Clinical trials: Demyelinating Disorder
Multiple Sclerosis
A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients
The primary purpose of this study is to demonstrate pharmacokinetic bioequivalence of ofatumumab injected by Pre-filled Syringe (PFS) versus Auto-Injector (AI) devices and thereby establish a bridge between the ongoing Phase 3…
- Trial name
- NCT03560739
- Testing
- ofatumumab with PRF, ofatumumab with AI
- Where
- 41 sites in United States, Austria and 7 more
- Volunteers
- 284 people
- Sponsor
- Novartis Pharmaceuticals
Neuromyelitis Optica
High Frequency Impulse Therapy for Neuropathic Pain in NMOSD
The aim of this study is to determine whether self-administered, at-home use of a transcutaneous electrical nerve stimulating device is an effective, acceptable and feasible method of relief from neuropathic pain among patients…
- Trial name
- NCT04614454
- Testing
- High Frequency Impulse Therapy
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Massachusetts General Hospital
Multiple Sclerosis
Wearable Lower Extremity Exoskeleton to Promote Walking in Persons With Multiple Sclerosis
The purpose of this study is to investigate whether a wearable robotic exoskeleton can help people with multiple sclerosis (MS) to walk again.
- Trial name
- NCT02519244
- Testing
- Ekso® (Wearable lower limb exoskeleton)
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- The University of Texas Health Science Center, Houston
Immune Reconstitution Inflammatory Syndrome, Leukoencephalopathy, Progressive Multifocal
Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)
The objectives of this study are to explore the effects of administering high-dose corticosteroids to participants who developed progressive multifocal leukoencephalopathy (PML) while on natalizumab as measured by time-course…
- Trial name
- IRIS (NCT01211665)
- Testing
- Methylprednisolone, Prednisolone
- Where
- 3 sites in United States, Germany
- Volunteers
- 3 people
- Sponsor
- Biogen
Multiple Sclerosis
Study of Oral Fampridine-SR in Multiple Sclerosis
To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.
- Trial name
- NCT00127530
- Testing
- Fampridine-SR
- Where
- 34 sites in United States, Canada
- Volunteers
- 300 people
- Sponsor
- Acorda Therapeutics
Multiple Sclerosis
Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple Sclerosis
The primary objective of the study is to assess the effect of long-term treatment with prolonged-release fampridine (BIIB041) 10 mg twice daily on the physical component scale (PCS) of the Short Form 36 Health Status…
- Trial name
- ENABLE (NCT01480076)
- Testing
- Fampridine
- Where
- 59 sites in Australia, Belgium and 7 more
- Volunteers
- 901 people
- Sponsor
- Biogen
Neuromyelitis Optica, Devic's Disease
An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica
The purpose of this study is to determine if the drug eculizumab reduces the attack rate and improves outcome in patients with neuromyelitis optica.
- Trial name
- NCT00904826
- Testing
- Eculizumab
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Mayo Clinic
Multiple Sclerosis, Cognitive Impairment
Exercise Training Effects on Cognition and Brain Function in Multiple Sclerosis: Project EXACT
Cognitive impairment is highly prevalent, poorly-managed, and disabling in persons with MS and exercise training might represent a promising approach to manage this symptom of the disease.
- Trial name
- NCT03677440
- Testing
- Treadmill Walking Exercise Training, Stretching-and-Toning Exercise Training
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Kessler Foundation
Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis
A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MS
The purpose of this study is to examine the effect of treatment with fampridine in patients with secondary progressive MS (SPMS) or primary progressive MS (PPMS) with upper limb dysfunction (as defined by a 9-HPT time of between…
- Trial name
- NCT02208050
- Testing
- Fampridine
- Where
- 2 sites in Ireland
- Volunteers
- 64 people
- Sponsor
- University College Dublin
Relapsing-remitting Multiple Sclerosis
COMparison Between All immunoTherapies for Multiple Sclerosis.
The overarching goal of this study is to determine whether rituximab (RTX) offers effectiveness and safety advantages over other commonly used approved Disease-Modifying Drugs (DMT) in the largest real-world population-based…
- Trial name
- COMBAT-MS (NCT03193866)
- Testing
- Rituximab
- Where
- Sweden
- Volunteers
- 3,526 people
- Sponsor
- Karolinska Institutet
Neuropathic Pain, Chronic Pain
Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis
This study will determine whether treatment with an extended-release opioid or topical lidocaine is effective in relieving distal symmetric lower extremity burning pain associated with multiple sclerosis (MS).
- Conditions
- Neuropathic Pain, Chronic Pain, Multiple Sclerosis
- Trial name
- NCT00414453
- Testing
- Lidocaine patch 5%, Extended-release oxycodone
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- University of Rochester
Multiple Sclerosis
Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis
The purpose of this study is to evaluate if monthly natalizumab, initiated after delivery, is effective in preventing postpartum relapses.
- Trial name
- NAPPREMS (NCT03046251)
- Testing
- Natalizumab
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- State University of New York at Buffalo
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
This study is an extension study to the pivotal study IgPro20_3003 (NCT01545076). The purpose of this extension study is to investigate the long-term treatment of CIDP with IgPro20, with regard to safety and efficacy.
- Trial name
- NCT02027701
- Testing
- IgPro20
- Where
- 33 sites in United States, Australia and 9 more
- Volunteers
- 82 people
- Sponsor
- CSL Behring
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis
The purpose of this study is to better understand the mechanism of action (MoA) of cladribine tablets by exploring the effect on central nervous system (CNS) and blood biomarkers relevant in the relapsing forms of multiple…
- Trial name
- CLOCK-MS (NCT03963375)
- Testing
- Cladribine
- Where
- 5 sites in United States
- Volunteers
- 47 people
- Sponsor
- Gregory Wu
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP
Adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who have completed study 161403 will be able to take part in this study.
- Trial name
- NCT02955355
- Testing
- HYQVIA
- Where
- 35 sites in United States, Argentina and 16 more
- Volunteers
- 85 people
- Sponsor
- Baxalta now part of Shire
Multiple Sclerosis, Relapsing-Remitting, Clinically Isolated Syndrome
Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis
The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.
- Trial name
- OLTERMS (NCT00595920)
- Testing
- Tovaxin
- Where
- 27 sites in United States
- Volunteers
- 116 people
- Sponsor
- Opexa Therapeutics, Inc.
Infantile Refsum's Disease, Zellweger Syndrome
Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid
OBJECTIVES: I. To Evaluate the therapeutic efficacy of cholic acid during provision of compassionate treatment to patients with identified inborn errors of bile acid synthesis and metabolism II.
- Conditions
- Infantile Refsum's Disease, Zellweger Syndrome, Adrenoleukodystrophy, Peroxisomal Disorders
- Trial name
- NCT00007020
- Testing
- Cholic Acids
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Multiple Sclerosis
Efficacy and Safety of GTR in Comparison to Copaxone®
The purpose of this study is demonstrate that efficacy and safety of Synthon's glatiramer acetate (GTR) is equivalent to Copaxone® (Teva) in patients with relapsing remitting multiple sclerosis
- Trial name
- GATE (NCT01489254)
- Testing
- Glatiramer Acetate (GTR), Glatiramer Acetate (Copaxone®)
- Where
- 133 sites in United States, Belarus and 17 more
- Volunteers
- 794 people
- Sponsor
- Synthon BV
Metachromatic Leukodystrophy (MLD)
Metazym for the Treatment of Patients With Late Infantile Metachromatic Leukodystrophy (MLD)
Objectives: The overall objective is to evaluate the safety, efficacy and pharmacokinetics (PK) of rhASA treatment in patients with late infantile MLD.
- Trial name
- NCT00418561
- Testing
- rhASA - Dose Level 1, rhASA - Dose Level 2, rhASA - Dose Level 3
- Where
- Denmark
- Volunteers
- 13 people
- Sponsor
- Shire
Multiple Sclerosis
Collection of Blood Samples From Patients With Relapsing MS Who Developed ITP After Receiving Lemtrada
Primary Objective: To collect blood samples in a new cohort of Relapsing Forms of Multiple Sclerosis (RMS) participants who had developed immune thrombocytopenic purpura (ITP) after LEMTRADA treatment, for future Deoxyribonucleic…
- Trial name
- LEMTRADA-ITP (NCT03784898)
- Testing
- Blood draw for future biomarker analysis
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Genzyme, a Sanofi Company