Clinical trials: Demyelinating Diseases
- Condition Demyelinating Diseases
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Multiple Sclerosis, Relapsing-Remitting
A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)
The purpose of the study is to determine if cladribine tablets are a safe and effective treatment for relapsing-remitting multiple sclerosis (RRMS).
- Trial name
- CLARITY (NCT00213135)
- Testing
- Cladribine 5.25 mg/kg, Cladribine 3.5 mg/kg
- Volunteers
- 1,326 people
- Sponsor
- EMD Serono
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Efficacy and Safety Study of I10E in Treatment of Patients With CIDP
Primary objective: To assess the efficacy of I10E in improving the disability of patients with CIDP. Secondary objective: To assess the safety of I10E in patients with CIDP.
- Trial name
- PRISM (NCT02293460)
- Testing
- I10E
- Where
- 33 sites in France, Italy and 4 more
- Volunteers
- 44 people
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Multiple Sclerosis, Relapsing-Remitting
A Phase IV Study of Rebif ® 44mcg Administered Three Times Per Week by Subcutaneous Injection Compared With no Treatment in the Therapy of Relapsing Multiple Sclerosis After Mitoxantrone
In the course of therapy escalation, the multiple sclerosis (MS) subjects with high activity of disease receive mainly mitoxantrone.
- Trial name
- REMAIN (NCT01142466)
- Testing
- Interferon beta-1a (Rebif)
- Volunteers
- 30 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Multiple Sclerosis
Rebif® Pregnancy Registry
The objective for establishing the Rebif® Pregnancy Registry is to collect prospective outcomes data on women in the United States and Canada who have been exposed to Rebif® during their pregnancies.
- Trial name
- NCT00338741
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- EMD Serono
Multiple Sclerosis
Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis
The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β [IFN-β] or glatiramer Acetate [GA] in patients with multiple sclerosis [MS] with relapses.
- Trial name
- NCT00811395
- Testing
- Teriflunomide, Interferon-β [IFN-β], Glatiramer Acetate [GA]
- Where
- 7 sites in United States, Austria and 5 more
- Volunteers
- 182 people
- Sponsor
- Sanofi
Cerebral Adrenoleukodystrophy (CALD)
A Study of the Efficacy and Safety of Hematopoietic Stem Cells Transduced With Lenti-D Lentiviral Vector for the Treatment of Cerebral Adrenoleukodystrophy (CALD)
This trial assessed the efficacy and safety of autologous cluster of differentiation 34 (CD34+) hematopoietic stem cells, transduced ex-vivo with Lenti-D lentiviral vector (also called elivaldogene autotemcel or eli-cel), for the…
- Trial name
- NCT01896102
- Testing
- Lenti-D Drug Product (eli-cel)
- Where
- 8 sites in United States, Argentina and 4 more
- Volunteers
- 32 people
- Sponsor
- Genetix Biotherapeutics Inc.
Multiple Sclerosis
This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)
This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e.
- Trial name
- NCT03599245
- Testing
- Ocrelizumab
- Where
- 161 sites in Argentina, Belgium and 24 more
- Volunteers
- 1,055 people
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis
A Multicenter, Open-label, RebiSmart™ Autoinjector Ease of Use Study
The purpose of this study is to test the RebiSmart™ for ease of use multiple domains related to subject's acceptability and satisfaction reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects…
- Trial name
- Performs (NCT01036165)
- Testing
- RebiSmart™
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- EMD Serono
Multiple Sclerosis
Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis
Primary Objective: To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing…
- Trial name
- TERIKIDS (NCT02201108)
- Testing
- Teriflunomide
- Where
- 57 sites in United States, Belgium and 20 more
- Volunteers
- 166 people
- Sponsor
- Genzyme, a Sanofi Company
Fatigue in Multiple Sclerosis
Effect of Physical ACtivity in Fingolimod Treated patiEnts (PACE) With Relapsing-remitting Multiple Sclerosis
This study evaluated the effect of an individualized web-based physical training in fingolimod -treated patients.
- Trial name
- PACE (NCT01490840)
- Testing
- Physical exercise
- Where
- 32 sites in Germany
- Volunteers
- 178 people
- Sponsor
- Novartis Pharmaceuticals
Late Infantile Metachromatic Leukodystrophy
Long-term Metazym Treatment of Patients With Late Infantile Metachromatic Leukodystrophy (MLD)
This is a single center, open-label study of patients with late infantile MLD. All patients were previous treated 26 weeks in the phase I trial (EudraCT number: 2006-005341-11, NCT00418561).
- Trial name
- NCT00633139
- Testing
- Recombinant human Arylsulfatase A (rhASA)
- Where
- Denmark
- Volunteers
- 13 people
- Sponsor
- Shire
Multiple Sclerosis
Natalizumab (BG00002, Tysabri) Study in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
The primary objective of Part A is to determine the safety and tolerability of natalizumab administered over 24 weeks in Japanese participants with relapsing-remitting multiple sclerosis (MS).
- Trial name
- Tysabri Japan (NCT01440101)
- Testing
- Natalizumab (BG00002)
- Where
- 17 sites in Japan
- Volunteers
- 106 people
- Sponsor
- Biogen
Relapsing-remitting Multiple Sclerosis
Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif
The purpose of this study is to compare the injection site reaction and injection site pain after subcutaneous administration of either Betaferon 250µg or Rebif 44µg using different autoinjectors.
- Trial name
- NCT00317941
- Testing
- Betaferon/Betaseron, Rebif
- Where
- 59 sites in France
- Volunteers
- 220 people
- Sponsor
- Bayer
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder
A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)
The objectives of this time-to-event study were to assess the efficacy and safety of eculizumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who were anti-aquaporin-4 (AQP4)…
- Trial name
- NCT01892345
- Testing
- Eculizumab
- Where
- 70 sites in United States, Argentina and 16 more
- Volunteers
- 143 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Multiple Sclerosis
The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis
The primary objectives of this study were: to evaluate the effect of Tysabri® (natalizumab) on antibody responses after immunization with a neoantigen (keyhole limpet hemocyanin [KLH]) and a recall antigen (tetanus toxoid [Td])…
- Trial name
- NCT00536120
- Testing
- BG00002 (natalizumab), keyhole limpet hemocyanin (KLH), tetanus diphtheria toxoid vaccine (Td)
- Where
- 10 sites in United States
- Volunteers
- 60 people
- Sponsor
- Biogen
Multiple Sclerosis, Relapsing-Remitting
A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis
This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid [TT]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine [23-PPV] either unboosted or boosted…
- Trial name
- NCT02545868
- Testing
- 23-PPV, 13-PCV Booster, Influenza Vaccine
- Where
- 22 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- Hoffmann-La Roche
Inherited Metabolic Disorders (IMD)
MGTA-456 in Patients With Inherited Metabolic Disorders Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
This study is designed to assess the safety and efficacy of using MGTA-456 in patients with Inherited Metabolic Disorders (IMD) undergoing stem cell transplantation.
- Trial name
- NCT03406962
- Testing
- MGTA-456
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Magenta Therapeutics, Inc.
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
The intent of this study is to demonstrate the efficacy and safety of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in newly or previously diagnosed CIDP subjects.
- Trial name
- ICE (NCT00220740)
- Testing
- Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified, Albumin (Human) 25%, United States Pharmacopeia (USP)
- Where
- 32 sites in United States, Argentina and 8 more
- Volunteers
- 117 people
- Sponsor
- Grifols Therapeutics LLC
Multiple Sclerosis
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)
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 PPMS…
- Trial name
- GAVOTTE (NCT04548999)
- Testing
- Ocrelizumab, Antihistamine, Methylprednisolone
- Where
- 147 sites in United States, Argentina and 20 more
- Volunteers
- 769 people
- Sponsor
- Hoffmann-La Roche
Relapsing Multiple Sclerosis (RMS)
Effects of Cladribine Tablets on the PK of Microgynon®
The purpose of this study was to investigate the potential effects of cladribine on the pharmacokinetics (PK) of monophasic oral contraceptive microgynon® by assessment of its constituents, ethinyl estradiol (EE) and…
- Trial name
- NCT03745144
- Testing
- Cladribine, Microgynon®
- Where
- 7 sites in Germany, Poland
- Volunteers
- 28 people
- Sponsor
- Merck KGaA, Darmstadt, Germany