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Neurology

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Department of Neurology

USF Health Department of Neurology’s Clinical Trials

  • Amyotrophic Lateral Sclerosis

    PTC857-CNS-001-ALS (CARDINALS)

    		 The CARDINALS study is a clinical trial looking at PTC857, Utreloxastat, in people living with ALS. PTC857 is a 15-lipoxygenase inhibitor, that may reduce oxidative stress in cells. The study will look at the effects of PTC857 compared to an inactive placebo, or sugar pill. The trial lasts up to 52 weeks with 24 weeks of random treatment with PTC857 or placebo. After the first 24 weeks patients who continue to be eligible will receive the active medication for an additional 28 weeks. Safety and tolerability will be assessed every other week at clinic visits.    For more information, please visit this website:  NCT05349721 To enroll in this study at USF please contact Sruthi Kommi Reddy at (813)974-9413

    HEALEY ALS Platform Trial - Master Protocol

    - Currently Enrolling

    		 The HEALEY ALS Platform Trial is a research trial that tests the safety and effectiveness of multiple treatments in ALS. A regimen is a specific course of treatment, each with a different study drug. Multiple different regimens may be active within the platform trial at the same time. If you qualify for the platform trial, you will be randomly assigned to a regimen (one treatment). You will have an equal chance of being assigned to any active regimen. However, if you complete a regimen and then choose to participate in another regimen, you will not be randomized to your first regimen again. Within a regimen, you will have a 3 in 4 chance of being assigned to the active drug group, and a 1 in 4 chance of being assigned to the placebo group. For more information, please visit this website:  NCT04297683 To enroll in this study at USF please contact Jessica Shaw at (813) 974-9413

  • Ataxia & Movement Disorders

    FA – ALCAR – Currently Enrolling

    The purpose of this study is to learn how treatment with acetyl-L-carnitine (ALCAR) will affect the hearts of patients with Friedreich's Ataxia as well as how it may affect other symptoms of Friedreich's Ataxia such as difficulties with balance, walking, or upper arm function.

     For more information please visit the website at https://clinicaltrials.gov/ct2/show/NCT01921868

    To enroll in this study at USF please contact Magee McGriff at 813-974-1414

    FA – Reata – Currently Enrolling

    This 2-part study will evaluate the efficacy, safety, and pharmacodynamics of omaveloxolone (RTA 408) in the treatment of patients with Friedreich's ataxia.

    For more information please visit the website at: https://clinicaltrials.gov/ct2/show/NCT02255435

    To enroll in this study at USF please contact Magee McGriff at 813-974-1414

    FA – COMS – Currently Enrolling

    This is a long-term study of the natural progression of disease in Friedreich’s Ataxia (FA)

     

    To enroll in this study at USF please contact Magee McGriff at 813-974-1414

    Retrotope RTMOTION – Ongoing Not Enrolling

    This is a study of a wearable gait device detecting movement in 3D in patients with movement disorders.

     

    To enroll in this study at USF please contact Magee McGriff at 813-974-1414

    SCA - IVIG 2014 – Currently Enrolling

    The purpose of this study is to learn how Intravenous Immune Globulin (IVIG) will affect Spinocerebellar Ataxia (SCA) symptoms and how it will affect motor and nervous system function in participants Subtypes of SCA to be examined will include SCA types 1, 2, 3, 6, 10 and 11.

    For more information please visit the website at:

    https://clinicaltrials.gov/ct2/show/NCT02287064

    To enroll in this study at USF please contact Magee McGriff at 813-974-1414

    FA - Gait and Balance – Currently Enrolling

    The purpose of this study is to assess gait and balance changes in Friedreich’s ataxia patients over the course of 12 months and correlate these changes to clinical measures of ataxia.

     

    To enroll in this study at USF please contact Magee McGriff at 813-974-1414

    PSP - BMS CN002-003 – Currently Enrolling

    The goal of this study is to evaluate the safety and tolerability of multiple doses of BMS-986168 in patients with PSP.

    For more information please visit the website at:

    https://clinicaltrials.gov/ct2/show/NCT02460094

    To enroll in this study at USF please contact Magee McGriff at 813-974-1414

    SCA - BHV4157-201 (Biohaven) – Start-up/Pending

    The purpose of this study is to compare the efficacy of BHV-4157 versus placebo on ataxia symptoms in subjects with spinocerebellar ataxia (SCA).

    For more information please visit the website at:

    https://clinicaltrials.gov/ct2/show/NCT02460094

    To enroll in this study at USF please contact Magee McGriff at 813-974-1414

    PSP - Abbvie M15-562 – Start-uo/Pending

    The purpose of this study is to assess the efficacy and long term safety and tolerability of ABBV-8E12 for up to 52 weeks in subjects with progressive supranuclear palsy (PSP).

     

    To enroll%2%

  • Huntington’s Disease

    Enroll HD

    Ongoing - Currently Enrolling

    		 Enroll HD is an observational study for families effected by Huntington’s Disease. This study monitors how the disease materializes and changes over time in different individuals. This study is open to people with HD, as well as, those who are at-risk. The Enroll HD study is intended to speed up discoveries and develop new therapies for Huntington’s Disease. For more information on this study please visit the Enroll-HD’s website at: www.enroll-hd.org To enroll in this study at USF please contact RN Clinical Coordinator Kelly Elliott at (813)974 -6022 
    GENERATION HD2 A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen compared with Placebo in Participants With Prodromal and Early Manifest Huntington's Disease. This study will evaluate the safety, biomarkers, and efficacy of Tominersen compared with placebo in participants with prodromal and early manifest Huntington's Disease. To read more about this study please visit https://clinicaltrials.gov/ct2/show/NCT05686551 To enroll in this study at USF please contact Clinical Research Associate Youshra Ahmed at 813-974-3361 or yahmed42@usf.edu

    Gut Microbiome in Huntington Disease 

    Ongoing  

    		 The purpose of this study is to find out if there is a connection between the naturally occurring bacteria in our bodies and the progression of HD.    To enroll in this study at USF please contact Clinical Research Associate Youshra Ahmed at 813-974-3361 or yahmed42@usf.edu

    PROOF-HD 

    Active - Not Currently Enrolling

    		  Phase III clinical trial. The objective of this study is to determine whether treatment with pridopidine can affect the rate of functional status decline in HD compared to placebo.  For more information on this study please visit: https://huntingtonstudygroup.org/proof-hd/ To enroll in this study at USF please contact Clinical Research Associate Youshra Ahmed at 813-974-3361 or yahmed42@usf.edu

    SAGE-718 DIMENSION 

    Currently Enrolling

    		  Phase IIb clinical trial. The objective of this study is to evaluate the safety, tolerability, and dosing of branaplam, and to evaluate its effects on specific on biological and clinical measures in HD.  For more information on this study please visit: https://clinicaltrials.gov/ct2/show/NCT05111249  To enroll in this study at USF please contact Clinical Research Associate Youshra Ahmed at 813-974-3361 or yahmed42@usf.edu
    Virtual UHDRS (vUHDRS)

    This objective of this study is to determine whether gold standard clinical rating scales for HD are valid when done via a telehealth video visit. This study involves two in person visits and one virtual visit over the course of 4-6 weeks of involvement

    		   To enroll in this study at USF please contact Clinical Research Associate Youshra Ahmed at 813-974-3361 or yahmed42@usf.edu

  • Multiple Sclerosis

     AGNOS
    Enrolling -
    2022 - Present 

    		 Evaluate the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes https://clinicaltrials.gov/ct2/show/NCT05084638?term=agnos&draw=2&rank=1
    		 For more information please call Amber McPherson at (813) 974-9423

    ALITHIOS
    Ongoing - Not Currently Enrolling -    2018 -Present

    		 This is an extension study of the COMB-ASCLEPIOS study and the COMB-POLOS study which is evaluating the long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis https://clinicaltrials.gov/ct2/show/NCT03650114?term=alithios&draw=2&rank=1 
    		 For more information please call Amber McPherson at (813) 974-9423

    Brain Shuffle  Enrolling -      2021 - Present

    		 This is an open-label single ascending dose, phase I study investigating the safety, tolerability, immunogenicity, pharmokinetics, and pharmocodynamics of IV RO7121932 in patients with multiple sclerosis
    		 https://www.isrctn.com/ISRCTN16295177?q=brain%20shuttle&filters=&sort=&offset=2&totalResults=4&page=1&pageSize=10&searchType=basic-search
    		 For more information please call Amber McPherson at (813) 974-9423
    CONSONANCE
    Ongoing -
    Not Currently Enrolling -    2018 -Present    		 This is an Open-label, single-arm 4-year study evaluating effectiveness and safety of ocrelizumab treatment in patients with Progressive Multiple Sclerosis

    https://clinicaltrials.gov/ct2/show/NCT03523858?term=consonance&draw=2&rank=1 

    		 For more information please call Amber McPherson at (813) 974-9423 
    EMBOLD Ongoing  - 
    Not Currently Enrolling -   2021 - Present    		 This double-blind clinical trial is a evaluating the efficacy and safety of evobrutinib compared to teriflunomide in participants with relapsing multiple sclerosis 

    https://clinicaltrials.gov/ct2/show/NCT04338061?term=evobrutinib&recrs=d&type=Intr&cond=Multiple+Sclerosis&draw=2&rank=1

     

    		 For more information please call Amber McPherson at (813) 974-9423 

    EVOLUTION
    Ongoing -
    Not Currently Enrolling -
    2020 - Present

    		 This is an open-label, single-arm study evaluating the effectiveness and safety of ocrelizumab in patients with early stage relapsing remitting multiple sclerosis https://clinicaltrials.gov/ct2/show/NCT03085810?titles=ocrelizumab+in+patients+with+early+stage+relapsing+
    remitting+multiple+sclerosis&draw=2&rank=1

    		For more information please call Amber McPherson at (813) 974-9423

    FENHANCE - Enrolling -    2020 - Present

    		 This randomized double-blind trial is evaluating the efficacy and safety of fenebrutinib compared with teriflunomide in patients with relapsing multiple sclerosis
    https://fenstudies.com/fenhance/     		For more information please call Amber McPherson at (813) 974-9423
    FENTREPID  Enrolling -   2020 - Present This randomized double-blind trial is evaluating the efficacy and safety of fenebrutinib compared with ocrelizumab in patients with primary progressive multiple sclerosis https://fenstudies.com/fentrepid/

    		 For more information please call Amber McPherson at (813) 974-9423

    GAVOTTE  Enrolling -    2020 - Present

    		 This randomized double-blind trial is evaluating the efficacy, safety, and pharmokinetics of a higher dose of ocrelizumab in patients with primary progressive multiple sclerosis https://clinicaltrials.gov/ct2/show/NCT04548999?term=ocrelizumab%2C+higher&cond=Primary+Progressive+Multiple+Sclerosis&draw=2&rank=1

    		For more information please call Amber McPherson at (813) 974-9423
    GEMINI I/II 
    Ongoing -
    Not Currently Enrolling -    2020 - Present      		This is Phase 3, randomized double-blind trial evaluating the efficacy and safety of SAR442168 compared to teriflunomide in participants with relapsing multiple sclerosis  https://clinicaltrials.gov/ct2/show/NCT04410978?term=SAR442168&draw=2&rank=2

    		For more information please call Amber McPherson at (813) 974-9423 
    HERCULES  Ongoing -
    Not Currently Enrolling -    2020 - Present    		 This is Phase 3, randomized double-blind trial evaluating the efficacy and safety of SAR442168 compared to placebo in participants with secondary multiple sclerosis  https://clinicaltrials.gov/ct2/show/NCT04411641?term=SAR442168&cond=Secondary+Progressive+Multiple+Sclerosis&draw=2&rank=1

    		For more information please call Amber McPherson at (813) 974-9423
    ICP-CL-00112  Enrolling -    2021 - Present This is Phase 2, randomized placebo-controlled trial studying orelabrutinib in patients with relapsing-remitting multiple sclerosis to evaluate the efficacy, safety, tolerability, pharmokinetic and biological activity https://clinicaltrials.gov/ct2/show/NCT04711148?term=orelabrutinib&cond=Relapsing+Remitting+Multiple+Sclerosis&draw=2&rank=1

    		For more information please call Amber McPherson at (813) 974-9423
    LAMPETIA  Ongoing -
    Not Currently Enrolling -      2021 - Present    		 This is a Phase 2,  double-blind, randomized, placebo controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis
    		 https://clinicaltrials.gov/ct2/show/NCT04879628?term=sar441344&draw=2&rank=3
    		 For more information please call Amber McPherson at (813) 974-9423
     LTS16004 
    Ongoing -
    Not Currently Enrolling -
    2019 - Present     		 This is a Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis
    		 https://clinicaltrials.gov/ct2/show/NCT03996291?term=lts16004&draw=2&rank=1
    		 For more information please call Amber McPherson at (813) 974-9423
    MASTER-2 Enrolling -      2019 - Present Cladribine tablets: Observational evaluation of effectiveness and patient-reported outcomes in sub-optimally controlled patients previously taking oral disease-modifying drugs for relapsing forms of multiple sclerosis
    		 https://clinicaltrials.gov/ct2/show/NCT03933202?type=Obsr&cond=cladribine&draw=2&rank=8 
    		 For more information please call Amber McPherson at (813) 974-9423 

    MOVES-IT
    Enrolling -
    2022 - Present 

    		 This is a Phase 1 study of the safety and tolerability of single and multiple doses of ANK-700 in patients with relapsing-remitting multiple sclerosis
    		 https://clinicaltrials.gov/ct2/show/NCT04602390?term=ank-700&draw=2&rank=1  For more information please call Amber McPherson at (813) 974-9423 
    MUSETTE    Ongoing -
    Not Currently Enrolling -    2020 - Present     		 This randomized double-blind trial is evaluating the efficacy, safety, and pharmokinetics of a higher dose of ocrelizumab in patients with relapsing multiple sclerosis
    		 https://clinicaltrials.gov/ct2/show/NCT04544436?term=1800&type=Intr&cond=ocrelizumab&draw=2&rank=1
    		 For more information please call Amber McPherson at (813) 974-9423
    OCARINA I  Ongoing -
    Not Currently Enrolling -      2019 - Present    		 A Phase 1B, Open-label, Multi-center study to investigate the pharmakinetics, safety, and tolerability of subcutaneous ocrelizumab administration in patients with multiple sclerosis
    		 https://clinicaltrials.gov/ct2/show/NCT03972306?term=ocrelizumab%2C+subcutaneous&draw=2&rank=1  For more information please call Amber McPherson at (813) 974-9423
    OCARINA II
    Ongoing -
    Not Currently Enrolling -
    2022 - Present    		 This study will evaluate the pharmacokinetics, pharmacodynamics, safety, immunogenicity, and radiological and clinical effects of subcutaneous (SC) administration of ocrelizumab compared with the intravenous (IV) infusion of ocrelizumab in patients with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS)
    		 https://clinicaltrials.gov/ct2/show/NCT05232825?term=ocarina&draw=2&rank=1
    		 For more information please call Amber McPherson at (813) 974-9423
    OLIKOS
    Ongoing -
    Not Currently Enrolling -
    2021 - Present    		 This is a single-arm trial exploring the efficacy of ofatumumab therapy in patients with relapsing multiple sclerosis who discontinue anti-CD20 monoclonal antibody (aCD20mAB) therapy
    		 https://clinicaltrials.gov/ct2/show/NCT04486716?term=olikos&draw=2&rank=1
    		 For more information please call Amber McPherson at (813) 974-9423
    PASS     Ongoing -
    Not Currently Enrolling -    2017 - Present
    		 A prospective, multicenter, observational, post-authorization safety study to evaluate the long term safety profile of LEMTRADA® (alemtuzumab) treatment in patients with relapsing forms of multiple sclerosis
    		For more information please call Amber McPherson at (813) 974-9423  
    PERSEUS    Enrolling -    2020 - Present This is Phase 3, randomized double-blind trial evaluating the efficacy and safety of SAR442168 compared to placebo in participants with primary progressive multiple sclerosis  https://clinicaltrials.gov/ct2/show/NCT04458051?term=perseus&draw=2&rank=8

    		For more information please call Amber McPherson at (813) 974-9423 

    REMODEL-1
    Enrolling -
    2022 - Present

    		 This study will evaluate the pharmacokinetics, pharmacodynamics, safety, immunogenicity, and radiological and clinical effects of subcutaneous (SC) administration of ocrelizumab compared with the intravenous (IV) infusion of ocrelizumab in patients with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS)
    		 https://clinicaltrials.gov/ct2/show/NCT05147220?term=remibrutinib&draw=2&rank=1

    		 For more information please call Amber McPherson at (813) 974-9423 

    SOSTOS
    Enrolling -
    2023 - Present

    		 This study will assess the efficacy, safety and tolerability of ofatumumab 20mg sc monthly versus continued current therapy in relapsing-remitting multiple sclerosis after elevation of serum neurofilament light levels
    		 https://clinicaltrials.gov/ct2/show/NCT05090371?term=sostos&draw=2&rank=1
    		  
    SPHERES  Enrolling -      2022 - Present This registry aims to study the natural history of patients with neuromyelitis optica spectrum disorder(NMOSD), real-world effectiveness and safety of approved and off-label medications used in treatment of NMOSD and drug utilization treatment patterns https://clinicaltrials.gov/ct2/show/NCT04886492?term=spheres%2C+NMOSD&draw=2&rank=1

    		For more information please call Amber McPherson at (813) 974-9423 
    TG1101-RMS303      
    Not Currently Enrolling - 
    2019 - Present    		 This is a noncomparative extension trial to ULTIMATE, to investigate the long-term safety and tolerability of ublituxumab in patients with relapsing multiple sclerosis https://clinicaltrials.gov/ct2/show/NCT04130997?term=tg1101-rms303&draw=2&rank=1 
    		 For more information please call Amber McPherson at (813) 974-9423 
    TREAT MS    Enrolling -    2018 - Present This multi-center clinical trial is evaluating whether an "early aggressive" therapy approach, versus starting with a first-line therapy, influences risk of disease accumuluation https://clinicaltrials.gov/ct2/show/NCT03500328?term=ocrelizumab%2C+higher&cond=Multiple+Sclerosis%2C+Relapsing-Remitting&draw=2&rank=7
    		 For more information please call Amber McPherson at (813) 974-9423 
    Verismo    Ongoing -
    Not Currently Enrolling - 
    2019 - Present    		 This is an observational study of ocrelizumub-treated patients with multiple sclerosis to determine the incidence and mortality rates of breast cancer and other malignancies For more information please call Amber McPherson at (813) 974-9423  

  • Neuromuscular Disease

    Dermatomyositis studies

    Updated July 2023

    ALXN1210-DM-310 (FLEX)
    -Currently Enrolling

    		 This is a Phase 2/3, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in adult participants with dermatomyositis (DM).

    For more information, please visit this website: 

    NCT04999020

    		 To enroll in this study at USF please contact Jessica Shaw at (813)974-9413.
    A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) (RECLAIIM)
    -Currently Enrolling     		 The purpose of this study is to evaluate if the study drug (IgPro20, which is a mixture of antibodies) is effective in treating Dermatomyositis (DM). IgPro20 is available in the United States, Europe, Switzerland, Canada, Japan, and other countries under the brand name Hizentra® for other diseases. IgPro20 is a research medicine in this phase 3 study because it has not been approved yet to treat DM. Your study participation will include a screening period (for up to 2 months) followed by 15 site visits during a 52-week treatment period. You may receive either subcutaneous IgPro20 or Placebo during participation.

    For more information, please visit this website:  

    NCT04044690

    		 To enroll in this study at USF please contact Jessica Shaw at (813)974-9413.

    Idiopathic Inflammatory Myopathy (IIM)

    Updated July 2023
    ARGX-113-2007 (ALKIVIA) 
    -Currently Enrolling    		 This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in adult patients with Idiopathic Inflammatory Myopathy (IIM). People with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome [ASyS]) will be included in the study.

    For more information, please visit these websites:  

    NCT05523167

    Alkivia Study

    		 To enroll in this study at USF please contact Jessica Shaw at (813)974-9413.

    Janssen IIM (SPIREA)

    -Enrolling soon

    		 The SPIREA Study is evaluating the safety and efficacy of an investigational medication (a medication not approved for clinical use) when used with standard-of-care medications for adults with active IIM. 

    For more information, please visit these websites: 

    NCT05379634

    The Spirea Study

    		 To enroll in this study at USF please contact Jessica Shaw at (813)974-9413. 

    Myasthenia Gravis studies

    Updated July 2023
    Myasthenia Gravis Inebilizumab Trial (MINT) Myasthenia Gravis
    -Currently Enrolling     		MINT is a clinical research study exploring an investigational drug for people with Myasthenia Gravis (MG). By participating, you may receive and investigational study drug (called Inebilizumab) designed to target the source of MG by reducing the activity of cells that produce antibodies and improve communication between your nerves and muscles.

    For more information, please visit this website:  

    NCT04524273

    		To enroll in this study at USF please contact Jessica Shaw at (813)974-9413.

    ALXN1720-MG-301 (PREVAIL)
    -Currently Enrolling

    		 The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of generalized MG (gMG) in adults with autoantibodies against acetylcholine receptor (AChR). 

    For more information, please visit these websites: 

    NCT05556096

    Prevail Study

    		 To enroll in this study at USF please contact Jessica Shaw at (813)974-9413.

    ALXN2050-MG-201 (ExpanD)
    -Currently Enrolling

    		 This study will evaluate the efficacy and safety of ALXN2050 (120 milligrams [mg], 180 mg) in participants with generalized myasthenia gravis (gMG).Safety will be monitored throughout the study.

    For more information, please visit these websites: 

    NCT05218096

    ExpanD study

    		 To enroll in this study at USF please contact Jessica Shaw at (813)974-9413.

    Cartesian MG-001
    -Currently Enrolling

    		 This is a Phase IIb study to evaluate the safety and preliminary efficacy of Descartes-08 CAR T-cells in patients with Generalized Myasthenia Gravis.

    For more information, please visit this website:

    NCT04146051

    		 To enroll in this study at USF please contact Jessica Shaw at (813)974-9413.

    Participants With Generalized Myasthenia Gravis Treated With C5 Inhibition Therapies 

    -Currently Enrolling

    		 This study focuses on people with gMG who have used a certain class of medications. The class is called complement component 5 (C5) inhibition therapies (referred to as “C5IT”). Soliris® is an example of a C5IT. This study will take place at several study doctor’s offices across the United States. We plan to include up to 500 participants. We will follow study participants for up to 5 years. 

    For more information, please visit this website:   

    NCT04202341

    		 To enroll in this study at USF please contact Jessica Shaw at (813)974-9413.
    Regeneron NIMBLE study
    -Currently Enrolling    		 The goal of this study is to evaluate the effect of pozelimab + cemdisiran on daily functioning that is impacted by signs and symptoms in patients with symptomatic generalized myasthenia gravis (gMG).

    For more information, please visit this website:   

    NCT05070858

    		 To enroll in this study at USF please contact Jessica Shaw at (813)974-9413.

    Janssen Pediatric MG (VIBRANCE)

    -Currently Enrolling

    		 The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (<) 18 years of age, the safety and tolerability of treatment with nipocalimab in children and adolescents and to evaluate the pharmacokinetics (PK) of nipocalimab in children and adolescents with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing, stable standard-of-care therapy. 

    For more information, please visit these websites:    

    NCT05265273

    https://globaltrialfinder.janssen.com/trial/CR109137

    		 To enroll in this study at USF please contact Jessica Shaw at (813)974-9413.

    Immunovant FLEX MG trial

    -Enrolling soon!

    		 The FLEX Study is a Phase 3 clinical trial to assess the efficacy and safety of an investigational at home injectable drug as induction and maintenance therapy for adults with Generalized Myasthenia Gravis (gMG). 

    For more information, please visit these websites:  

    NCT05403541

    https://flex.researchstudytrial.com 

    		 To enroll in this study at USF please contact Jessica Shaw at (813)974-9413.

    Neuropathy Studies - includes Multifocal Motor Neuropathy (MMN)

    Updated July 2023

     

     ARDA
    -Currently Enrolling

    		 This is a phase 2, randomized, double-blinded, placebo-controlled, parallel-group, multicenter trial to evaluate the safety and efficacy of 2 dose regimens of ARGX-117 versus placebo, in participants with Multifocal Motor Neuropathy (MMN) previously stabilized with IVIg (intravenous immunoglobulin).

    For more information, please visit these websites: 

    NCT05225675

    Arda Study

    		 To enroll in this study at USF please contact Jessica Shaw at (813)974-9413.

    DM1 Studies

    Updated July 2023

     HBS-101-CL-005

    -Currently Enrolling

    		 Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1. 

    For more information, please visit this website: 

    NCT04886518

    		 To enroll in this study at USF please contact Jessica Shaw at (813)974-9413.

    Upper Limb Spasticity studies

    Updated July 2023

    Dysport® and Botox® in Adults With Upper Limb Spasticity (DIRECTION)

    -Currently Enrolling

    		 This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at optimal doses according to approved prescribing information of each product.

    For more information, please visit this website: 

    NCT04936542

    		 To enroll in this study at USF please contact Jessica Shaw at (813)974-9413.

  • Parkinson’s Disease

    Biotie

    This clinical trial to an adjunctive medication to reduce end of dose wearing off in PD patients (Tozadenant). Placebo controlled with Open Label Extension

    For more information please visit the website at: www.biotie.com

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Civitas

    This clinical trial to an adjunctive medication to reduce end of dose wearing off in PD patients (Inhaled Levodopa). Open Label Extension trial

     

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Cynapsus

    This clinical trial to an adjunctive medication to reduce end of dose wearing off in PD patients (Sublingual ApoMorphine).Open Label Extension trial.

    For more information please visit the website at: www.sunovion.com

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Intec

    This clinical trial to evaluate the efficacy of an Accordion Pill style medication with less doses and reduce OFF time. Placebo controlled with Open Label Extension

     

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Pfizer

    This clinical trial aims to reduce OFF time and reduce Sinemet dosing. Placebo Controlled with an Open Label Extension

    For more information please visit the website at: www.pfizer.com

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Pfizer

    This clinical trial is for Early PD patients on MAOB medication. Placebo Controlled.

     

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    MJFF

    Observational trial for people of Ashkenzani Jewish Decent or first degree relatives with PD

    For more information please visit the website at: www.michaeljfox.org

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Lundbeck

    Medication to control Orthostatic Hypotension in Parkinson's Disease patients. Placebo Controlled

    For more information please visit the website at: www.lundbeck.com

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    NIH

    Early PD patients within 3 years diagnosis currently not on treatment. Placebo Controlled.

     

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Impax

    This trial is to assess the Pharmacokeinetics in patients with Advanced Parkinson's Disease

    For more information please visit the website at: www.impaxpharma.com

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Neuroderm

    Sinemet delivered through a subcutaneous infusion as an adjunct to oral Sinemet

    For more information please visit the website at www.neuroder.com

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    Sunovion

    Medication to control halluncinations in patients with Advanced Parkinson's Disease. Placebo controlled

    For more information please visit the website at www.sunovion.com

    To enroll in this study at USF please contact Claudia Rocha at 813-396-0757

    PD and ED - Sagene2014 – Currently Enrolling

    The purpose of this study is to see if selegiline and tadalafil (generic for Cialis®) results in an improvement in Erectile dysfunction (ED) in male patients with Parkinson's disease (PD) and moderate ED. Male PD patients who have an incomplete response to tadalafil alone will be given both medications to see if the addition of selegiline improves ED symptoms more than tadalafil alone. It is common practice for a medical doctor to prescribe these two drugs to a patient like you. However, there have been no studies conducted to examine the effects of these medications when taken together.

    For more information please visit the website at: https://clinicaltrials.gov/ct2/show/NCT02225548

    To enroll in this study at USF please contact Magee McGriff at 813-974-1414

    PD - Emory-LRRK2 – Currently Enrolling

     

     

    To enroll in this study at USF please contact Magee McGriff at 813-974-1414

    PD - B7601011 (Pfizer Early PD) – Currently Enrolling

    This study is intended to evaluate the effect of PF-06649751 on safety and efficacy in a population of patients with early stage Parkinson’s disease.

     

    To enroll in this study at USF please contact Magee McGriff at 813-974-1414
    PD – ND0612H Clinical Trial for a liquid carbidopa/levodopa formulation is delivered by subcutaneous infusion via a small pump worn on a belt or placed in a pocket to alleviate motor fluctuations in people with Parkinson’s Disease. This study is a one year open-label study in which all patients receive ND0612.Given the very high level of interest in this therapy the enrollment period is expected to be only a few weeks, probably only extending until the end of August.   To enroll in this study at USF please contact Leigh Harrell at 813-396-0786.

    PSP - BMS CN002-004 (extension) – On-going Currently Not Enrolling

    The goal of this study is to evaluate long-term safety and pharmacokinetics during multiple IV infusions of BMS-986168 in PSP patients. In addition to demonstrating multiple dose long-term safety and tolerability, BMS-986168 is expected to lower free eTau concentrations in the CSF of these patients. This study will also evaluate the progression of PSP patients treated with BMS-986168 on pharmacodynamic (PD) endpoints as well as clinical, magnetic resonance imaging (MRI), and eye tracking assessments.

    For more information please visit the website at:

    https://clinicaltrials.gov/ct2/show/NCT02658916

    To enroll in this study at USF please contact Magee McGriff at 813-974-1414

  • Stroke

    ARCADIA

    Currently Enrolling

    		 Multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients with cryptogenic stroke. The purpose of this study is to determine if apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy. 

    For more information on this study please visit this website: https://clinicaltrials.gov/ct2/show/NCT03192215

    To enroll in this study at USF please contact Tara McTigue at (813)259-0826

     BMS CV010 Factor IX inhibitor

    Currently Enrolling

    		  A Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Response-Adaptive Dose- Ranging Study of BMS-986177, an Oral Factor XIa Inhibitor, for the Prevention of New Ischemic Stroke or New Silent Brain Infarction in Patients Receiving Aspirin and Clopidogrel Following Acute Non-Hemorrhagic Stroke or Transient Ischemia Attack (TIA). The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention.  For more information on this study please visit this website: http://https//clinicaltrials.gov/ct2/show/NCT03766581?term=CV010-031&draw=2&rank=1 To enroll in this study at USF please contact Tara McTigue at (813)259-0826

     MOST

    Currently Enrolling

    		  Multi-arm Optimization of Stroke Thrombolysis (MOST): a blinded, randomized controlled adaptive, multi-arm, adjunctive-thrombolysis efficacy trial in ischemic stroke.   The primary efficacy objective of the MOST trial is to determine if argatroban (100µg/kg bolus followed by 3µg/kg per minute for 12 hours) or eptifibatide (135µg/kg bolus followed by 0.75µg/kg/min infusion for two hours) results in improved 90-day modified Rankin scores (mRS) as compared with placebo in acute ischemic stroke (AIS) patients treated with 0.9mg/kg IV rt-PA within three hours of symptom onset.  For more information on this study please visit this website: http://https//clinicaltrials.gov/ct2/show/NCT03735979?term=Multi-arm+Optimization+of+Stroke+Thrombolysis&draw=2&rank=1 To enroll in this study at USF please contact Tara McTigue at (813)259-0826

     CHARM

    Currently Enrolling

    		  Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction  For more information on this study please visit this wesbite: http://https//clinicaltrials.gov/ct2/show/NCT03735979?term=Multi-arm+Optimization+of+Stroke+Thrombolysis&draw=2&rank=1 To enroll in this study at USF please contact Tara McTigue at (813)259-0826

     Pisces (Stem cells) 

    Currently Enrolling

    		  A Randomized, Placebo-Controlled Study of the Efficacy and Safety of Intracerebral Stem Cells (CTX0E03) in Subjects with Disability Following an Ischemic Stroke   To enroll in this study at USF please contact Tara McTigue at (813)259-0826

    TCSD-S 

    Currently Enrolling 

    		  Disparities in Transition of Care after Acute Stroke Hospitalization: The Transition of Care Stroke Disparity Study. This study is identifying the disparities in care for patients who are discharged directly home after acute stroke.  For more information on this study please visit this website: http://https//clinicaltrials.gov/ct2/show/NCT03452813?cond=TCSD-S&draw=2&rank=1 To enroll in this study at USF please contact Tara McTigue at (813)259-0826

     Sleep SMART 

    Currently Enrolling

    		  Sleep for Stroke Management And Recovery Trial. Use of Cpap machine after ischemic stroke   The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.  For more information on this study please visit this website: http://https//clinicaltrials.gov/ct2/show/NCT03812653?term=Sleep+SMART&draw=2&rank=1 To enroll in this study at USF please contact Tara McTigue at (813)259-0826

    ASPIRE

    Currently Enrolling

    		 Anticoagulation for Stroke Prevention and Recovery after ICH. The goal of this study is to determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF).  For more information on this study please visit the website: http://https//clinicaltrials.gov/ct2/show/NCT03907046?term=Anticoagulation+for+Stroke+Prevention+and+Recovery+after+ICH&draw=2&rank=1 To enroll in this study at USF please contact Tara McTigue at (813)259-0826
     Pacific-Stroke (Bayer) (Pending) The purpose of this study is to try to find the best dose of the study drug to give to participants and to look at how well BAY 2433334 works in preventing another stroke, whether the study drug is safe for the participants, and how it affects the body. This study is also done to learn how the study drug moves into, through and out of the body.  For more information on this study please visit the website: http://https//clinicaltrials.gov/ct2/show/NCT04304508?term=Pacific-Stroke&draw=2&rank=1 To enroll in this study at USF please contact Tara McTigue at (813)259-0826

  • Epilepsy

     

    CVL-865-SZ-001 (REALIZE)  Currently Enrolling

     

    Research study testing an experimental drug called CVL-865 for adults (18 to 75 years old) with focal epilepsy who still experience seizures despite taking medication. The trial aims to determine if adding CVL-865 to current anti-seizure medications can improve seizure control while assessing safety.

     

    For more information on this study please visit the website: https://clinicaltrials.gov/study/NCT04244175?term=CVL-865-SZ-001&rank=1

    Realize Trial

    		 For additional information about potential enrollment please contact:        Marina Azevedo:  (813) 230-2323      Ana Omura:          (813) 259-8524

     

    EQU2-02 (EQUILIBRIUM) Currently Enrolling

    		 Research study investigating an experimental drug called EQU-001 for adults (18 to 65 years old) with focal epilepsy who continue to have seizures despite medication. The trial aims to evaluate if adding EQU-001 to current anti-seizure medications can improve seizure control while ensuring safety.

    For more information on this study please visit the website: https://clinicaltrials.gov/study/NCT05473442?term=EQU-202%20EQUILIBRE&rank=1

    Equilibre Biopharmaceuticals Trial 

    		 For additional information about potential enrollment please contact:        Marina Azevedo:  (813) 230-2323      Ana Omura:          (813) 259-8524

    GWEP19022 (ILLUMINATE) Currently Enrolling

    		 Safety study for individuals with Lennox-Gastaut Syndrome, Dravet Syndrome, or Tuberous Sclerosis Complex who receive or will start Epidiolex therapy. The trial focuses on evaluating the safety of Epidiolex and monitoring any associated risks.
    		 For more information on this study please visit the website: https://clinicaltrials.gov/study/NCT05044819?term=GWEP19022&rank=1 For additional information about potential enrollment please contact:        Marina Azevedo:  (813) 230-2323      Ana Omura:          (813) 259-8524
    LP352-201 (LONGBOARD) Currently Enrolling 
    		 Research study testing an experimental drug called LP352 for patients (12 to 65 years old) with Developmental and epileptic encephalopathy (DEE) such as Lennox-Gastaut Syndrome, Dravet Syndrome, and Tuberous Sclerosis Complex. The trial aims to determine if adding LP352 to current anti-seizure medications can improve seizure control
    		 For more information on this study please visit the website: https://clinicaltrials.gov/study/NCT05364021?term=LP352-201%20&rank=2
    		 For additional information about potential enrollment please contact:        Marina Azevedo:  (813) 230-2323      Ana Omura:          (813) 259-8524
    YKP509C003 (CARISBAMATE) Currently Enrolling
    		 Research study investigating an experimental drug called YKP509 for individuals (4 to 55 years old) diagnosed with Lennox-Gastaut Syndrome and experiencing drop seizures. The trial aims to evaluate if adding YKP509 to current anti-seizure medications can effectively improve drop seizure control.
    		 For more information on this study please visit the website: https://clinicaltrials.gov/study/NCT05219617?term=YKP509C003&rank=1 For additional information about potential enrollment please contact:        Marina Azevedo:  (813) 230-2323      Ana Omura:          (813) 259-8524

    NP100016 (NAUTILUS Trial)      Currently Enrolling 

    		 Research study assessing the effectiveness of a device called Responsive Neurostimulation System (RNS)* for individuals (12 years and older) with idiopathic generalized epilepsy (IGE) who experience generalized tonic-clonic seizures (GTCs). The trial evaluates if the RNS system, in addition to current anti-seizure medications, can improve seizure control.  *The RNS system is currently FDA approved for patients diagnosed with focal epilepsy (when seizures come from one side of the brain).

    For more information on this study please visit the website: https://clinicaltrials.gov/study/NCT05147571?term=nautilus&rank=1

    NAUTILUS Epilepsy Study 

    		 For additional information about potential enrollment please contact:        Marina Azevedo:  (813) 230-2323      Ana Omura:          (813) 259-8524
    YKP3089C025 (Xcopri Trial)   Currently Enrolling 
    		 Research study investigating a drug called Cenobamate (Xcopri) for adults (18 years and older) diagnosed with idiopathic generalized epilepsy (IGE) and experiencing primary generalized tonic-clonic seizures (GTCs). The trial aims to determine if adding Cenobamate to current anti-seizure medications can improve seizure control.
    		 For more information on this study please visit the website: https://clinicaltrials.gov/study/NCT03678753?term=YKP3089C025&rank=2  For additional information about potential enrollment please contact:        Marina Azevedo:  (813) 230-2323      Ana Omura:          (813) 259-8524
    1024SE3003 (RAISE Trial)    Currently Enrolling
    		 Research study testing an experimental drug called Ganaxolone for patients (12 years and older) diagnosed with Status Epilepticus (SE), a prolonged seizure condition. The trial assesses whether administering Intravenous (IV) Ganaxolone can effectively terminate ongoing seizure activity in individuals with Status Epilepticus, while monitoring safety. 

    For more information on this study please visit the website: https://classic.clinicaltrials.gov/ct2/show/NCT04391569

    Marinus Pharmaceuticals 

    		 For additional information about potential enrollment please contact:        Marina Azevedo:  (813) 230-2323      Ana Omura:          (813) 259-8524
    EP0162      (STARS Trial)  Currently Enrolling      The STARS (Stand Together Against pRolonged Seizures) Research Study is a clinical trial for a drug called Alprazolam, which is sometimes used to treat seizures. This study aims to determine if Alprazolam, administered via a Staccato Inhaler Device, will work to stop prolonged seizures that last more than 3 minutes. 

    For more information on this study please visit the website: https://clinicaltrials.gov/study/NCT05077904?term=EP0162%20STACCATO&rank=1

    UCB STARS Trial 

    		 For additional information about potential enrollment please contact:        Marina Azevedo:  (813) 230-2323      Ana Omura:          (813) 259-8524
    REMI-01-23 (REMI Trial) Currently Enrolling
    		 A study for adults aged 18 to 70 years old who have a history of seizures, including epileptic, non-epileptic or unknown seizures. Participants in this study experience seizures and their healthcare provider has recommended an at-home electroencephalogram (EEG). This study aims to investigate whether an extended EEG duration (REMI) yields a higher number of detected events compared to a standard EEG.

    For more information on this study please visit the website: https://clinicaltrials.gov/study/NCT05818930?term=remi%20epitel&rank=1

    Epitel

    		 For additional information about potential enrollment please contact:        Marina Azevedo:  (813) 230-2323      Ana Omura:          (813) 259-8524
    STUDY005226 (NELLI Trial)  Currently Enrolling 
    		 This is a research study of an experimental device called Nelli for individuals who have a history of seizures with a motor component, including epileptic, non-epileptic or unknown seizures. Participants in this study experience seizures that involve some form of body movement, and their healthcare provider has recommended an at-home electroencephalogram (EEG) to monitor their brain activity during these episodes. The purpose of this study is assess if the NELLI artificial intelligence device can correctly identify seizures.
    		 For more information on this study please visit the website: https://www.neuroeventlabs.fi/
    		 For additional information about potential enrollment please contact:        Marina Azevedo:  (813) 230-2323      Ana Omura:          (813) 259-8524
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