Department of Neurology

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Clinical Trials

  • HEALEY ALS Platform Trial - Master Protocol

    - Enrolling Soon!

    		 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

    https://www.massgeneral.org/neurology/als/research/platform-trial

    		 To enroll in this study at USF please contact Sruthi Kommi Reddy at (813) 974-9413

    Updated: Oct 2024

  • 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 Health  please contact:
    Lucrectia Campbell or Paige Graham
    (813) 974-5909

    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 Health please contact:
    Lucrectia Campbell or Paige Graham
    (813) 974-5909

    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 Health  please contact:
    Lucretia Campbell or Paige Graham
    (813) 974-5909

    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 Health please contact:
    Lecretia Campbell or Paige Graham
    (813) 974-5909

    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 Health please contact:
    Lucretia Campbell or Paige Graham
    (813) 974-5909

    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 Health please contact:
    Lucretia Campbell or Paige Graham
    (813) 974-5909

    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 Health please contact:
    Lucretia Campbell or Paige Graham
    (813) 974-5909

    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 Health please contact:
    Lucretia Campbell or Paige Graham
    (813) 974-5909

    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 in this study at USF Health please contact: Lucretia Campbell or Paige Graham (813) 974-5909

  • 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

  • Adult Facial Pain Trials

    NOE-TGN-201

    Libra

    (Currently Enrolling)

    A Phase II/III, Multicentre, 8-week Run-in Phase Followed by a 12-Week, Prospective, Parallel-group, Double-blind, Randomized Withdrawal, Placebo-controlled Study, with a 52-Week Open Label Extension, to Evaluate the Efficacy and Safety of Daily 1.5 to 3.5 mg Basimglurant in Patients with Pain Associated with Trigeminal Neuralgia with Suboptimal Response to their Current Anti-pain Therapy.

    For more information please contact:

    Allyssa Sawyer at (813) 396-2736

    Adult Headache Trials

    M21-307

    Preclude

    (Active - 
    Not Currently Enrolling)

    Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX (Botulinum Toxin Type A) for the Prevention of Migraine in Subjects with Episodic Migraine.

    For more information please contact:

    Allyssa Sawyer at (813) 396-2736

    Pediatric Headache Trials

    H8H-MC-LAHV

    PIONEER-PEDS1

    (Currently Enrolling)

    A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1.

    For more information please contact:

    Justis Root at (813) 396-2282

    H8H-MC-LAHW

    PIONEER-PEDS2

    (Currently Enrolling)

    A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients with Migraine - PIONEER-PEDS2.

    For more information please contact:

    Justis Root at (813) 396-2282

    I5Q-MC-CGAS

    REBUILD-1

    (Currently Enrolling)

    A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age with Episodic Migraine – the REBUILD-1 Study.

    For more information please contact:

    Justis Root at (813) 396-2282

    I5Q-MC-CGAT

    REBUILD-2

    (Currently Enrolling)

    A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age with Chronic Migraine – the REBUILD-2 Study.

    For more information please contact:

    Justis Root at (813) 396-2282

    3110-305-002

    (Currently Enrolling)

    A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-attack Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17).

    For more information please contact:

    Allyssa Sawyer at (813) 396-2736

    3110-306-002

    (Currently Enrolling)

    A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17).

    For more information please contact:

    Allyssa Sawyer at (813) 396-2736

    P255-501 “ROAR”

    (Currently Enrolling)

    A Randomized, Double-Blind, Placebo-Controlled,

    Parallel-Group, Phase 4 Study to Evaluate the Efficacy and

    Safety of Qudexy® XR in the Prevention of Migraine in Children 6 to 11 Years of Age.

    For more information please contact:

    Allyssa Sawyer at (813) 396-2736

    19379A-Rejoin

    (Currently Enrolling)

    Long term, open label (dose blinded), extension study of eptinezumab in children and adolescents with chronic or episodic migraine.

    For more information please contact:

    Allyssa Sawyer at (813) 396-2736

    19357A- Prospect 1

    (Currently Enrolling)

    Interventional, randomized, double-blind, parallel-group,

    placebo-controlled study to evaluate the efficacy and safety of

    intravenous (IV) eptinezumab in pediatric patients (6 to

    17 years) for the preventive treatment of episodic migraine.

    For more information please contact:

    Allyssa Sawyer at (813) 396-2736

    19356A- Prospect 2

    (Currently Enrolling)

    Interventional, randomized, double-blind, parallel-group,

    placebo-controlled study to evaluate the efficacy and safety of IV

    eptinezumab in adolescents (12-17 years) for the preventive treatment of chronic migraine.

    For more information please contact:

    Allyssa Sawyer at (813) 396-2736

    CLIN-52120-463

    C-BEOND

    		  

    A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study with Extension Phase to Evaluate the Efficacy and Safety of Dysport for the Prevention of Chronic Migraine in Adult Participants.

    		  

    For more information please contact:

    Allyssa Sawyer at (813)396-2736

  • 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 Contact HD Center at 813-974-6022  option 2

    SAGE-718 PURVEIW  Ongoing -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 Contact HD Center at 813-974-6022  option 2

  • AGNOS
    Ongoing - Not Currently 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

    cosMOG   Enrolling Soon!

    		 A randomized, double-blind, placebo-controlled, Phase 3 study evaluating the efficacy and safety of rozanolixizumab in participants with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD)
    		 https://clinicaltrials.gov/study/NCT05063162?term=mog001&rank=1
    		 To enroll in this study please contact Amber McPherson at (813) 974-9423
    ENHANCE  Enrolling 2023-Present This is an open-label trial evaluating the efficacy when transitioning from current anti-CD20 therapy to ublituxumab
    		 https://clinicaltrials.gov/study/NCT05877963?cond=Multiple%20Sclerosis&intr=Ublituximab&rank=1
    		 To enroll in this study please contact Amber McPherson at (813) 974-9423

    FENHANCE - Ongoing - Not Currently 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  Ongoing - Not Currently 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

    FREXALT  Currently Enrolling 2024-Present

    		 This randomized, double-blind, Phase 3 study is comparing efficacy and safety of frexalimab (SAR441344) to teriflunomide in adult participants with relapsing forms of multiple sclerosis
    		 https://clinicaltrials.gov/study/NCT06141473?intr=sar441344&rank=6
    		 To enroll in this study please contact Amber McPherson at (813) 974-9423

    FUSION  Currently Enrolling 2024-Present

    		 This 2-part, multicenter, randomized, blinded, active-controlled phase 2 study will evaluate the safety and efficacy of BIIB091 Monotherapy and BIIB091 combination therapy with diroximel fumarate in participants With relapsing multiple sclerosis
    		 https://clinicaltrials.gov/study/NCT05798520?term=BIIB091&checkSpell=false&rank=3
    		 To enroll in this study please contact Amber McPherson at (813) 974-9423

    GAVOTTE 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 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) 974-9427
    ICP-CL-00112 Ongoing - Not Currently 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
    J3K-MC-KIAB(b)     2024 - Present
    		 This is  an adaptive phase 2a/2b, randomized, double-blind, parallel-group study to investigate the safety and efficacy of LY3541860 compared to placebo in slowing the occurrence of new T1 gadolinium-enhancing lesions in adult participants with relapsing multiple sclerosis
    		 https://clinicaltrials.gov/study/NCT06220669?cond=Multiple%20Sclerosis&intr=LY3541860&rank=1
    		 To enroll in this study please contact 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
    LTS17043  Ongoing - Not Currently Enrolling 2021-Present
    		 An interventional, Phase 3 extension study to investigate long-term safety and tolerability of tolebrutinib in participants with relapsing multiple sclerosis, primary progressive multiple sclerosis, or non-relapsing secondary progressive multiple sclerosis
    		 https://clinicaltrials.gov/study/NCT06372145?term=lts17043&rank=1
    		 For more information please call Amber McPherson at (813) 974-9421

    MASTER-2 Ongoing - Not Currently 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 - 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
    OPTIS  Enrolling 2024-Present
    		 This study will evaluate the performance and safety of a digital tool for the unsupervised self-assessment ofneuromyelitis optica spectrum disorder (NMOSD)compared to  standard in-clinic assessments
    		 https://clinicaltrials.gov/study/NCT05566769?term=NMOSDCOPILOT&rank=1
    		 To enroll in this study please contact 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 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 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

  • Myopathy studies: includes Dermatomyositis, Idiopathic Inflammatory Myopathy (IIM) and other myopathies

    Updated Oct 2024
    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:  

    NCT05523167

    Alkivia Study

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

    Myasthenia Gravis studies

    Updated Oct 2024

     ARGX-113-2308 (ADAPT-SERON)

    -Currently Enrolling

    		 More details coming soon! 

    For more information, please visit: 

     NCT06298552     		To enroll in this study at USF please contact Alexis Flores at (813)974-9413.

     CNP-106-5.001

    -Currently Enrolling

    		 More details coming soon! 

    For more information, please visit: 

    NCT06106672

    		  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 (ALXN-MG-501)

    -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:   

    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:   

    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:    

    NCT05265273

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

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

    DNTH103-MG-201 (MAGIC)

    -Currently Enrolling

    		 More details coming soon! 

    For more information, please visit:  

     NCT06282159

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

    MS700568_0183_ (MyClad)

    -Enrolling Soon!

    		 More details coming soon! 

    For more information, please visit:

    NCT06463587

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

    NMD670-02-0002 (SYNAPSE-MG)

    -Enrolling Soon!

    		 More details coming soon!

    For more information, please visit:

    NCT06414954

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

     ARGX-113-2315 (ADAPT OCULUS)

    -Enrolling Soon!

    		 More details coming soon!

    For more information, please visit:

    NCT06558279

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

    Neuropathy Studies - includes Multifocal Motor Neuropathy (MMN) and Chronic inflammatory demyelinating neuropathy (CIDP)

    Updated Oct 2024

    DNTH103-MMN-201 (MOMENTUM)

    -Enrolling Soon

    		 More details coming soon!

    For more information, please visit:

     

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

    Myotonic Dystrophy type 1 (DM1) Studies

    Updated Oct 2024

    Avidity AOC-1001-CS3 "HARBOR"

    -Enrolling soon!

    		 More details coming soon! 

    For more information, please visit:  

    NCT06411288

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

    Sanofi DFI17808

    -Enrolling soon!

    		 More details coming soon! 

    For more information, please visit:

     

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

    Spasticity studies

    Updated Oct 2024

    Efgartigimod for Stiff Person Syndrome (ESPS)

    -Enrolling soon!

    		 More details coming soon! 

    For more information, please visit:

    NCT06528392

    		 To enroll in this study at USF please contact Jessica Shaw at (813)974-9413.
  • Cerevance (CVN424-203)

    This study will examine the potential of CVN424 to improve motor and non-motor functions in individuals with early untreated Parkinson’s Disease (PD).

    Status: Recruiting

    For more information, review the study record:     

    https://clinicaltrials.gov/study/NCT06006247?spons=Cerevance&rank=2

    To enroll in this study at USF please contact:

    Erica Botting (813) 974-8026

    CVL-751-PD-003

    Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations (TEMPO-3) 

    The purpose of this study is to assess the effect of tavapadon on the change from baseline in total daily hours of "on" time without troublesome dyskinesia in L-Dopa-treated participants with Parkinson's Disease (PD) who are experiencing motor fluctuations.

    Status: Recruiting

    For more information, please visit:

    https://clinicaltrials.gov/study/NCT04542499?term=robert%20hauser&rank=1

    To enroll in this study at USF please contact:

    Erica Botting (813) 974-8026
    283PD201 LUMA, Biogen 

    A Study to Assess the Safety of BIIB122 Tablets and if it Can Flow the Worsening of Early-Stage Parkinson’s Disease in Participants Between the Ages of 30 and 80 (LUMA)

    Status: Recruiting

    For more information, please visit:

    https://clinicaltrials.gov/study/NCT05348785?term=robert%20hauser&rank=7 

    To enroll in this study at USF please contact:

    Erica Botting (813) 974-8026
    Fixed-Dose Trial in Early Parkinson’s Disease (PD) (TEMPO-1) 

    The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.

    Status: Recruiting 

    For more information, please visit:

    https://clinicaltrials.gov/study/NCT04201093?term=robert%20hauser&rank=8 

    To enroll in this study at USF please contact:

    Erica Botting (813) 974-8026
    PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort (PPMI) 

    The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.

    Status: Recruiting

    For more information, please visit

    https://clinicaltrials.gov/study/NCT04477785?term=robert%20hauser&rank=9

    To enroll in this study at USF please contact:

    Erica Botting (813) 974-8026
    Everest, Jazz 

    A Study to Assess the Safety and Efficacy of JZP385 in the Treatment of Adults with Moderate to Severe Essential Tremor (ET)

    Status: Recruiting

    For more information, please visit:

    https://clinicaltrials.gov/study/NCT05122650?term=jzp385-201&rank=1 

    To enroll in this study at USF please contact:

    Erica Botting (813) 974-8026

    Patagonia, Jazz

    A study of suvecaltamide in adults with moderate to severe residual tremor in Parkinson’s Disease

    Status: Recruiting 

    For more information, please visit:

    https://clinicaltrials.gov/study/NCT05642442?term=jzp385-202&rank=1

    To enroll in this study at USF please contact:

    Erica Botting (813) 974-8026

    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:

    Erica Botting (813) 974-8026

    STEM - Parkinson’s Disease 

    This is a double-blinded, controlled, randomized clinical trial (RCT) to establish the safety and efficacy of a non-invasive neuromodulation device for treating symptoms associated with Parkinson's disease.

    Status: Recruiting

    For more information, please visit:

    https://clinicaltrials.gov/study/NCT04797611?term=SNS-PD-002&rank=1&limit=10 

    To enroll in this study at USF please contact:

    Erica Botting (813) 974-8026

  • 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: 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: 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