Department of Neurology

USF Health Department of Neurology’s Clinical Trials

  • Amyotrophic Lateral Sclerosis

    Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)

    - Currently Enrolling

    		 Radicava® (edarvone) is a drug approved by the FDA as a treatment for ALS in May of 2017. The study Sponsor, Mitsubishi Tanabe Pharma America (MTPA), manufactures and markets the drug. Edaravone has been shown to slow the loss of physical function in ALS. In this research study we want to learn what changes happen in patients with Amyotrophic Lateral Sclerosis (ALS) that can be seen in the blood and urine when they take Edaravone. These changes are called biomarkers. Because, ALS is not the same in all people, this study hopes to find biomarkers to show why Edaravone is slowing ALS symptom progression. If you decide to join this research study, it will take you about 24 weeks to complete the study (this does not include the time needed for insurance approval for Edaravone). During this time, we will ask you to make 8 study visits. For more information, please visit this website:  NCT04259255 To enroll in this study at USF please contact Jessica Shaw at 813-974-9413

    Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS (MT-1186-A02)

    - Currently Enrolling

    		 The main purpose of this research study is to test whether an experimental drug called edaravone, is effective as treatment against ALS, and if it is safe and well tolerated when given to patients with your illness. The study will compare the efficacy and safety of two different dosing regimens of oral forms of edaravone. For more information, please visit this website:   NCT04569084 To enroll in this study at USF please contact Jessica Shaw at 813-974-9413.

    A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS) (COURAGE-ALS)

    - Currently Enrolling

    		 The main purpose of this research study is to evaluate the efficacy and safety of reldesemtiv. By efficacy, we mean the effect of taking reldesemtiv and your ability to perform certain functional assessments. By safety, we mean the collection of information about whether there are any negative symptoms and/or side effects that may result from taking reldesemtiv. Additionally, this research study will evaluate the pharmacokinetics (PK) of reldesemtiv (how much reldesemtiv gets into the blood stream and how long it takes the body to get rid of it). If you agree to participate, your participation in the study will be about 52 weeks. For more information, please visit this website:  NCT04944784 To enroll in this study at USF please contact Naraly Requena 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

    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

    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

    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

    VIBRANT-HD 

    Currently Enrolling

    		  Phase II clinical trial. The objective of this study is to evaluate the effect of SAGE-718 on measures of cognitive function in HD.  For more information on this study please visit: https://clinicaltrials.gov/ct2/show/NCT05107128 To enroll in this study at USF please contact Clinical Research Associate Youshra Ahmed at 813-974-3361

  • Multiple Sclerosis

    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
    ARTIOS
    Currently Enrolling -    2020 - Present    		 This is a single-arm, open label study evaluating the effectiveness of ofatumumab treatment in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or
    fingolimod therapy    		 https://clinicaltrials.gov/ct2/show/NCT04353492?term=artios&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
    BTKI Extension
    Ongoing - Not Currently Enrolling -    2019 -Present    		 This is a Phase 2b dose-finding study for SAR442168, a Burton's tyrosine kinase inhibitor, in participants 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 
    CONSONANCE
    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 Enrolling -    2021 - Present This is a double-blind, placebo-controlled dose escalation study with open-label extension evaluating the safety and efficacy of ATA188 in subjects with progressive multiple sclerosis https://clinicaltrials.gov/ct2/show/NCT03283826?term=embold&draw=2&rank=1

    		For more information please call Amber McPherson at (813) 974-9423 
    ENSEMBLE    Ongoing - Not Currently Enrolling -    2017 - 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
    ESTEEM  Ongoing - Not Currently Enrolling -    2014 -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/NCT02047097

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

    EVOLUTION Ongoing - Not Currently Enrolling -    2020 - 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

    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  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  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  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
    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 
    MUSETTE    Ongoing - Not Currently Enrolling -    2019 - 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      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
    Ocre-Up  Enrolling -  2018-Present A single-center prospective measurement of upper extremity function in multiple sclerosis patients with advanced disability treated with Ocrevus™
    		 https://clinicaltrials.gov/ct2/show/NCT03562975?term=ocre-up&rank=1
    		 For more information please call Amber McPherson at (813) 974-9423
    OPERA I/II Ongoing - Not Currently Enrolling  Parallel group study to evaluate the efficacy and safety of Ocrelizumab in comparison to interferon Beta-1A (Rebif) in patients with relapsing MS. https://clinicaltrials.gov/ct2/show/NCT01412333?term=ocrelizumab%2C+beta-1a&draw=2&rank=1  For more information please call Amber McPherson at (813) 974-9423 
    OPTIMUM-LT  Ongoing - Not Currently Enrolling -    2017 - Present Multicenter, non-comparative extension to OPTIMUM, to investigate the long-term safety, tolerability, and control of disease of ponesimod in subjects with relapsing multiple sclerosis https://clinicaltrials.gov/ct2/show/NCT03232073?term=optimum-lt&draw=2&rank=1   For more information please call Amber McPherson at (813) 974-9423 
    PASS     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 

    RELEASE Enrolling -    2021 - Present

    		 This is a double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of Nabiximols oromucosal spray as an add-on therapy in patients with spasticity due to multiple sclerosis https://clinicaltrials.gov/ct2/show/NCT04203498?term=nabiximols%2C+spasticity&cond=Multiple+Sclerosis&draw=2&rank=3

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

    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.

    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:  NCT04259255  To enroll in this study at USF please contact Jessica Shaw at 813-974-9413.

    CIDP ADHERE Study (ARGX 1802) 

    – Currently Enrolling 

    		 The main goal of this study is to look at the effect and the safety of a subcutaneous formulation of drug called “efgartigimod PH20 SC” in people with chronic inflammatory demyelinating polyneuropathy (CIDP). Another goal of the study is to collect information on how well efgartigimod works, how your body processes efgartigimod, what efgartigimod does to your body, and how your immune system reacts to efgartigimod. You will also be asked about your quality of life and how you feel. The study will last up to 80 weeks and has 2 parts. “Stage A” and “Stage B”. About 360 people will take part in Stage A and up to 180 of the people from Stage A will also take part in Stage B. In Stage A, each subject will receive efgartigimod. A dummy drug that we call placebo will not be used. This means that you will get efgartigimod in Stage A. In Stage B, efgartigimod will be compared to placebo.  For more information, please visit this website:   NCT04281472 To enroll in this study at USF please contact Jessica Shaw at 813-974-9413.

    Registry of 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
         

  • 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

    Cavion Absence Epilepsy
    Currently Enrolling    		 This is a research study of an experimental drug called CX-8998 for adolescents and young adults who have absence epilepsy. The purpose of this study is to learn whether CX-8998 has any side effects when given for 27 days in total daily doses of 4 milligrams (mg) to 20 mg per day.

    For more information on this study please visit the website: https://clinicaltrials.gov/ct2/show/NCT03406702

    http://https//www.centerwatch.com/clinical-trials/listings/212730/a-phase-2a-safety-tolerability-pharmacokinetics-and-quantitative-eeg-study-of-cx-8998-in-adolescents-and-young-adults-with-generalized-epileptic-syndromes-with-absence-seizures/

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

     X-TOLE 

    Currently Enrolling

     

    X-TOLE Study is a Phase 2 double-blind study that is underway for patients with focal epilepsy currently taking between 1 and 3 anti-epileptic drugs that are still experiencing frequent seizures. Three doses of the investigational drug are being evaluated and some patients will be assigned to a placebo. The study includes a 2-month baseline and a 2-month randomized, double-blind treatment period followed by an optional open-label extension phase for up to 1 year

     

     For more information on this study please visit the website: http://https//clinicaltrials.gov/ct2/show/NCT03796962?term=XPF-008&draw=2&rank=3

    http://https//www.centerwatch.com/clinical-trials/listings/220957/a-randomized-double-blind-placebo-controlled-multicenter-study-to-evaluate-the-safety-tolerability-and-efficacy-of-xen1101-as-adjunctive-therapy-in-focal-onset-epilepsy/

    http://https//www.xtolestudy.com/

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

     SK Life YKP3089 

    Currently Enrolling

    		  This trial is intended to study the safety and effectiveness of an new anti-epileptic drug (AED) on Primary Generalized Tonic-Clonic (PGTC) Seizures. Eligible Subjects will continue to take their usual AEDs and receive either cenobamate or placebo. The treatment period is 22 weeks and there is a 3 week follow up period. Subjects who complete may be eligible for an extension study and will not have to complete the follow up period.  For more information on this study please visit the website: http://https//clinicaltrials.gov/ct2/show/NCT03678753?term=ykp3089&draw=2&rank=7 To enroll in this study at USF please contact Tara McTigue at (813)259-0826

     Realize Trial

    Currently Enrolling

    		  The purpose of this study is to assess the efficacy, safety, and tolerability profile of CVL-865 as adjunctive treatment in participants with drug-resistant focal onset seizures. Eligible Subjects will receive either CVL-865 or placebo.  The study treatment period is 25 weeks, and the subject will need to come to the study center at least 7 times over this period, including a screening visit.  For more information on this study please visit the website: http://https//clinicaltrials.gov/ct2/show/NCT04244175?term=cerevel&draw=2&rank=5 To enroll in this study at USF please contact Tara McTigue at (813)259-0826

     PAS NeuroPace 

    Currently Enrolling 

    		  This is a post-approval study (PAS) of the RNS System device, which is the first FDA-approved closed loop responsive neurostimulator designed to reduce the frequency of seizures in individuals with partial onset seizures. This study is a 5 year, non-randomized, open-label observational study that will collect data regarding safety and efficacy of the RNS System as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures.  For more information on this study please visit the website: http://https//clinicaltrials.gov/ct2/show/NCT02403843?term=neuropace&draw=4&rank=8 To enroll in this study at USF please contact Tara McTigue at (813)259-0826