Clinical trials: Demyelinating Disorders
Multiple Sclerosis, Relapsing-Remitting
A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration
Part 1: The primary objective is to evaluate the efficacy of natalizumab extended interval dosing (EID) (every 6 weeks [Q6W]) in participants who have previously been treated with natalizumab standard interval dosing (SID) (every…
- Trial name
- NCT03689972
- Testing
- Natalizumab
- Where
- 107 sites in United States, Australia and 9 more
- Volunteers
- 585 people
- Sponsor
- Biogen
Neuromyelitis Optica Spectrum Disorder
A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
This multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optica spectrum disorder (NMOSD) who completed open-label extension (OLE) period of…
- Trial name
- NCT04660539
- Testing
- satralizumab, azathioprine (AZA), mycophenolate mofetil (MMF)
- Where
- 53 sites in United States, Bulgaria and 16 more
- Volunteers
- 119 people
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis, Relapsing-Remitting
Natalizumab Re-Initiation of Dosing
The primary objectives of this study are to further evaluate the safety of natalizumab (Tysabri®) monotherapy by evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab, and to confirm the…
- Trial name
- NCT00306592
- Testing
- BG00002 (natalizumab)
- Where
- 63 sites in United States, Canada
- Volunteers
- 404 people
- Sponsor
- Biogen
X-Linked Adrenoleukodystrophy
Safety, Pharmacokinetics and Pharmacodynamics of NV1205 in Pediatric Male Subjects With Adrenoleukodystrophy
This is a phase I/II, open label dose escalation study of multiple dose levels of NV1205 with a long-term treatment phase.
- Trial name
- NCT03196765
- Testing
- Sobetirome (NV1205)
- Where
- 13 sites in Argentina, Australia and 6 more
- Sponsor
- NeuroVia, Inc.
Multiple Sclerosis
Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS)
The study is designed to determine the effect of weekly intramuscular (IM) administration of 30 mcg Avonex (interferon beta 1a) on safety parameters and gadolinium (Gd) enhanced and T2-weighted cranial magnetic resonance imaging…
- Trial name
- Avonex China (NCT01181115)
- Testing
- Avonex
- Where
- 10 sites in China
- Volunteers
- 60 people
- Sponsor
- Biogen
Progressive Multiple Sclerosis, Neuromyelitis Optica.
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica
Multiple sclerosis (MS) has been classically regarded as a chronic inflammatory autoimmune demyelinating disease of the central nervous system, along with a considerable pathological heterogeneity.
- Trial name
- NCT01364246
- Testing
- human umbilical cord mesenchymal stem cells
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.
Central Nervous System (CNS) Lesions, Brain Metastases
Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent
This Phase 2 clinical trial will study RVP-001, a new manganese-based MRI contrast agent, in people who are known to have gadolinium-enhancing central nervous system (CNS) lesions, for example brain tumors or multiple sclerosis.
- Conditions
- Central Nervous System (CNS) Lesions, Brain Metastases, Brain Neoplasms, Brain Neoplasms, Benign
- Trial name
- NCT06322342
- Testing
- RVP-001
- Where
- 5 sites in United States
- Volunteers
- 18 people
- Sponsor
- Reveal Pharmaceuticals Inc.
Multiple Sclerosis, Relapsing-Remitting
Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis
The purpose of this study is to determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis.
- Trial name
- NCT00235989
- Testing
- Interferon beta 1b (Betaseron, BAY86-5046)
- Where
- 17 sites in United States
- Volunteers
- 63 people
- Sponsor
- Bayer
Relapsing Remitting Multiple Sclerosis
Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).
Teva is developing a 40 mg/ml GA Injection, administered once daily under the skin, for the treatment of R-R MS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the…
- Trial name
- NCT00337779
- Testing
- Glatiramer Acetate (GA) 40 mg, glatiramer acetate 20 mg
- Volunteers
- 1,155 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Multiple Sclerosis
A Long-term Extension of Study GNC-401
This Phase II study is a monocenter, long-term extension study of study GNC-401 and will start after individual completion of Week 48 of the GNC-401 study. At entry, all patients will receive active treatment with temelimab.
- Trial name
- NCT05049161
- Testing
- Temelimab 18 mg/kg, Temelimab 36mg/kg, Temelimab 54 mg/kg
- Where
- Sweden
- Volunteers
- 33 people
- Sponsor
- GeNeuro Innovation SAS
Multiple Sclerosis, Muscle Spasticity
Comparison of Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex® (Tizanidine Hydrochloride Tablets) Taken While in the Fed State (Just After a Meal) and in the Fasted State (Before a Meal) in Patients With Moderate to Severe Spasticity.
This study is being conducted to compare the impact of somnolence (sleepiness) on cognition (awareness) as well as the safety and effectiveness of tizanidine hydrochloride capsules versus Zanaflex® (tizanidine hydrochloride…
- Conditions
- Multiple Sclerosis, Muscle Spasticity, Spinal Cord Injury, Stroke
- Trial name
- NCT00047580
- Testing
- tizanidine hydrochloride capsule
- Where
- 16 sites in United States
- Volunteers
- 120 people
- Sponsor
- Elan Pharmaceuticals
NMO Spectrum Disorder
Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)
The objectives of this phase Ib study are to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenic profiles of B001 in subjects with aquaporin-4 antibody (AQP4-IgG) positive NMOSD.
- Trial name
- NCT05145361
- Testing
- B001 injection
- Where
- 4 sites in China
- Volunteers
- 45 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
A First-in-Patient Clinical Trial of KINE-101 in Patients With Corticosteroid-Refractory CIDP
This is a multicenter, open-label, single-dose, dose-escalation study evaluating the safety and tolerability of intravenous (IV) KINE-101 in patients with corticosteroid-refractory chronic inflammatory demyelinating…
- Trial name
- NCT07343310
- Testing
- KINE-101
- Where
- 2 sites in South Korea
- Volunteers
- 9 people
- Sponsor
- Kine Sciences Co., Ltd.
Multiple Sclerosis
Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis
Multiple sclerosis (MS) is a chronic inflammatory disease associated with central nervous system (CNS) demyelination and subsequent axonal degeneration. Multiple sclerosis exhibits an unpredictable and variable clinical course.
- Trial name
- NCT01517282
- Testing
- MOR103
- Where
- 5 sites in Germany, Poland and 1 more
- Volunteers
- 32 people
- Sponsor
- MorphoSys AG
Multiple Sclerosis
A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
The main purpose of this study is to assess the bioequivalence of ocrelizumab SC test formulation to the marketed ocrelizumab SC reference formulation in participants with either relapsing multiple sclerosis (RMS) or primary…
- Trial name
- PORTAMENTO (NCT07074886)
- Testing
- Ocrelizumab Test Formulation, Ocrelizumab Reference Formulation
- Where
- 49 sites in United States, Argentina and 7 more
- Volunteers
- 193 people
- Sponsor
- Hoffmann-La Roche
Relapsing Forms of Multiple Sclerosis
A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone or With Diroximel Fumarate (DRF) in Adults With Relapsing Forms of Multiple Sclerosis (MS)
In this study, researchers will learn more about a study drug called BIIB091 in participants with MS who may be experiencing relapses. It is a 2-part study.
- Trial name
- FUSION (NCT05798520)
- Testing
- BIIB091, DRF
- Where
- 77 sites in United States, Bulgaria and 8 more
- Volunteers
- 127 people
- Sponsor
- Biogen
Multiple Sclerosis
Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis
Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once per day for 7 days is a safe and will induce a therapeutic effect in multiple sclerosis (MS) patients.
- Trial name
- NCT02034188
- Testing
- Umbilical cord mesenchymal stem cells
- Where
- Panama
- Volunteers
- 20 people
- Sponsor
- Translational Biosciences
Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive
Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple Sclerosis
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the safety, tolerability and activity of ibudilast administered twice daily over a 96 week period in subjects with…
- Trial name
- NCT01982942
- Testing
- ibudilast
- Where
- 28 sites in United States
- Volunteers
- 255 people
- Sponsor
- MediciNova
Relapsing-Remitting Multiple Sclerosis (RRMS)
A Study for Tysabri Participant Preference
The primary objective of this study is to collect, evaluate and compare data on participant preference between subcutaneous (SC) and intravenous (IV) natalizumab.
- Trial name
- NCT05304520
- Testing
- Natalizumab
- Where
- 40 sites in Germany
- Volunteers
- 318 people
- Sponsor
- Biogen
Leukodystrophy, Globoid Cell
An Observational Study of Pediatric Subjects With Globoid Cell Leukodystrophy (GLD)
The objective of this study is to evaluate the natural history of disease progression in infants with globoid cell leukodystrophy (GLD).
- Trial name
- NCT01093105
- Sponsor
- Shire