Department of Neurology
USF Health Department of Neurology’s Clinical Trials
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Amyotrophic Lateral Sclerosis
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
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: Jan 2024 -
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 Health please contact:
Lucrectia Campbell or Paige Graham
(813) 974-5909FA – 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) 974-5909FA – 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) 974-5909Retrotope 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) 974-5909SCA - 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:
To enroll in this study at USF Health please contact:
Lucretia Campbell or Paige Graham
(813) 974-5909FA - 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) 974-5909PSP - 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:
To enroll in this study at USF Health please contact:
Lucretia Campbell or Paige Graham
(813) 974-5909SCA - 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:
To enroll in this study at USF Health please contact:
Lucretia Campbell or Paige Graham
(813) 974-5909PSP - 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
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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
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
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
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
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
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
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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Headaches
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
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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
Ongoing - Not Currently Enrolling
2022 - PresentEvaluate 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 -PresentThis 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 -PresentThis 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 - PresentThis double-blind clinical trial is a evaluating the efficacy and safety of evobrutinib compared to teriflunomide in participants with relapsing multiple sclerosis
For more information please call Amber McPherson at (813) 974-9423 EVOLUTION
Ongoing -
Not Currently Enrolling -
2020 - PresentThis 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 - 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 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 - PresentThis 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 - PresentThis 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 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
LAMPETIA Ongoing -
Not Currently Enrolling - 2021 - PresentThis 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 - PresentThis 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 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 MOVES-IT
Ongoing - Not Currently Enrolling
2022 - PresentThis 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 - PresentThis 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 - PresentA 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 - PresentThis 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 - PresentThis 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 - PresentThis 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 - PresentThis 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 - PresentThis 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 - PresentThis 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
Myopathy studies: includes Dermatomyositis, Idiopathic Inflammatory Myopathy (IIM) and other myopathies
Updated Jan 2024
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) (RECLAIIM)
-Enrollment completeThe 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:
ARGX-113-2007 (ALKIVIA)
-Currently EnrollingThis 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:
To enroll in this study at USF please contact Jessica Shaw at (813)974-9413. Janssen IIM (SPIREA)
-Currently Enrolling
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:
To enroll in this study at USF please contact Jessica Shaw at (813)974-9413. Myasthenia Gravis studies
Updated Jan 2024
ALXN1720-MG-301 (PREVAIL)
-Currently EnrollingThe 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:
To enroll in this study at USF please contact Jessica Shaw at (813)974-9413. Cartesian MG-001
-Enrollment completeThis 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:
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 this website:
To enroll in this study at USF please contact Jessica Shaw at (813)974-9413. Regeneron NIMBLE study
-Currently EnrollingThe 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:
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:
To enroll in this study at USF please contact Jessica Shaw at (813)974-9413. Immunovant FLEX MG trial
-Currently Enrolling
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:
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 Jan 2024
More studies coming soon!!Myotonic Dystrophy type 1 (DM1) Studies
Updated Jan 2024
More studies coming soon!!
Upper Limb Spasticity studies
Updated Jan 2024
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:
To enroll in this study at USF please contact Jessica Shaw at (813)974-9413. -
Parkinson’s Disease
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
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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