Clinical trials: Demyelinating Diseases
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
Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis
This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS).
- Trial name
- KATHAROS (NCT06444113)
- Testing
- Ofatunumab
- Where
- 15 sites in United States, Germany and 3 more
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
This is a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.
- Trial name
- ADHERE (NCT04281472)
- Testing
- efgartigimod PH20 SC in stage B
- Where
- 216 sites in United States, Austria and 23 more
- Volunteers
- 322 people
- Sponsor
- argenx
Relapsing Multiple Sclerosis, Clinically Isolated Syndrome
Study to Assess Changes in Immunoglobulins in Patients With Relapsing Multiple Sclerosis Treated With Anti-CD20 Therapies
This was an observational retrospective cohort study using electronic medical records (EMRs) to study immunoglobulin levels over time among patients with relapsing forms of multiple sclerosis (MS) newly initiating anti-CD20…
- Conditions
- Relapsing Multiple Sclerosis, Clinically Isolated Syndrome, Relapsing-remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
- Trial name
- NCT06526000
- Where
- United States
- Volunteers
- 326 people
- Sponsor
- Novartis
Relapsing Multiple Sclerosis
A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk
The primary objective of the lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms…
- Trial name
- PROVIDE (NCT06143514)
- Testing
- No intervention
- Where
- 5 sites in United States
- Volunteers
- 16 people
- Sponsor
- TG Therapeutics, Inc.
Relapsing Remitting Multiple Sclerosis RRMS
A 3-year Multi-center Study to Describe Changes of OCT Parameters Under Treatment With Gilenya®
This was a 3-year, prospective, multi-center, open-label study to describe the long term changes of optical coherence tomography (OCT) parameters in RRMS patients under treatment with Fingolimod.
- Trial name
- PASSOS (NCT01705236)
- Testing
- Fingolimod
- Where
- 10 sites in Germany, Switzerland
- Volunteers
- 87 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)
This is a multicenter, longitudinal, single-arm, open-label study to describe the change from baseline in cognitive processing speed, measured by the SDMT, in subjects with RMS treated with ozanimod HCl 1 mg at 3 years.
- Trial name
- ENLIGHTEN (NCT04140305)
- Testing
- RPC-1063
- Where
- 61 sites in United States, Canada and 1 more
- Volunteers
- 188 people
- Sponsor
- Celgene
Central Neuropathic Pain, Multiple Sclerosis
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 capsules in the treatment of central neuropathic pain in participants with multiple sclerosis.
- Trial name
- PRIME (NCT01324232)
- Testing
- AVP-923-45, AVP-923-30, AVP-923-20
- Where
- 72 sites in United States, Argentina and 3 more
- Volunteers
- 209 people
- Sponsor
- Avanir Pharmaceuticals
Multiple Sclerosis, Relapsing-Remitting
An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-remitting MS
The purpose of this study is to determine the difference in preventing a relapse between Betaseron and Avonex. Patients with RRMS currently treated with Avonex will be randomized into 2 equal-size arms; one arm will continue on…
- Trial name
- ABOVE (NCT00206648)
- Testing
- Betaferon/Betaseron
- Where
- 53 sites in United States, Canada
- Volunteers
- 271 people
- Sponsor
- Bayer
Spasticity With Multiple Sclerosis
Evaluation of the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis
This study will be conducted to evaluate the effect of multiple doses of nabiximols compared with placebo on a clinical measure of velocity-dependent muscle tone in the lower limbs (Lower Limb Muscle Tone-6 [LLMT-6]) in…
- Trial name
- RELEASE MSS5 (NCT04984278)
- Testing
- Nabiximols
- Where
- 30 sites in United States, Czechia and 3 more
- Volunteers
- 56 people
- Sponsor
- Jazz Pharmaceuticals
Multiple Sclerosis
Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) "Prevention of Relapse of Multiple Sclerosis"
The purpose of this study is to evaluate the safety and efficacy of Copaxone subcutaneous injection syringe (hereinafter referred to as Copaxone) in patients with multiple sclerosis in the routine clinical setting.
- Trial name
- NCT03209479
- Testing
- Glatiramer acetate
- Where
- Japan
- Volunteers
- 1,332 people
- Sponsor
- Teva Takeda Pharma Ltd.
X-Linked Adrenoleukodystrophy
A Study to Prospectively Assess Disease Progression in Male Children With X-ALD
This is a non-interventional, multi-center study that follows general principles of periodic assessment of X-ALD patients in routine practice.
- Trial name
- NCT03278899
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- NeuroVia, Inc.
Neuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD)
Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)
The objectives of this study are to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of satralizumab in participants with NMO and NMOSD.
- Trial name
- NCT02073279
- Testing
- Satralizumab
- Where
- 58 sites in United States, Bulgaria and 13 more
- Volunteers
- 95 people
- Sponsor
- Hoffmann-La Roche
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder
An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients
The purpose of this study is to determine whether eculizumab long-term use is safe and effective in patients with relapsing NMO.
- Trial name
- NCT02003144
- Testing
- eculizumab
- Where
- 69 sites in United States, Argentina and 18 more
- Volunteers
- 119 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Multiple Sclerosis
An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis
Clinical study BCD-132-4/MIRANTIBUS is an international, multicenter, randomized, double-blind, double-masked study using an active reference drug (teriflunomide).
- Trial name
- MIRANTIBUS (NCT05385744)
- Testing
- BCD-132, Teriflunomide
- Where
- Russia
- Volunteers
- 336 people
- Sponsor
- Biocad
Multiple Sclerosis, Relapsing-Remitting
A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered Subcutaneously to Japanese Participants With Relapsing-Remitting Multiple Sclerosis
The primary objective of this study is to evaluate the efficacy of natalizumab 300 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) administrations up to 24 weeks in Japanese participants with relapsing-remitting multiple…
- Trial name
- NCT05265728
- Testing
- Natalizumab
- Where
- 12 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Biogen
Multiple Sclerosis
Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
This is a phase I, double-blind, placebo controlled, parallel group, dose-escalating, randomised study designed to assess and compare the safety and tolerability, PK, and immunogenicity of GNbAC1 administered as a single dose at…
- Trial name
- NCT03574428
- Testing
- GNbAC1
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GeNeuro Australia PTY Ltd
Multiple Sclerosis
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)
This is a randomized, double-blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with RMS…
- Trial name
- MUSETTE (NCT04544436)
- Testing
- Ocrelizumab, Antihistamine, Methylprednisolone
- Where
- 120 sites in United States, Argentina and 19 more
- Volunteers
- 864 people
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis, Relapsing-remitting
A Observational, Prospective Study to Assess the Impact of Fatigue in the Quality of Life of Patients With Multiple Sclerosis in Argentina
This is an observational, non-controlled, multicentric, prospective study planned to be conducted in 66 subjects diagnosed with multiple sclerosis (MS) in 20 centres of Argentina.
- Trial name
- NCT01080001
- Where
- Argentina
- Volunteers
- 71 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Relapsing-Remitting Multiple Sclerosis
An fMRI Study of Treatment Optimization Comparing Two Disease Modifying Therapies Used to Treat Relapsing Remitting Multiple Sclerosis
Impaired short term memory, attention and concentration lapses, and slower processing of information occur in up to 40-65% of patients with Multiple Sclerosis (MS).
- Trial name
- NCT00398528
- Testing
- Glatiramer acetate, (Copaxone®), IFN-β-1a, (Avonex®)
- Where
- 5 sites in United States
- Volunteers
- 48 people
- Sponsor
- Neurognostics