Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis
NCT ID: NCT02220244
Last Updated: 2017-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
105 participants
INTERVENTIONAL
2013-10-31
2018-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of MD1003 in Spinal Progressive Multiple Sclerosis
NCT02220933
Effect of MD1003 in Progressive Multiple Sclerosis (SPI2)
NCT02936037
Efficacy of Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of MS After a Clinically Isolated Syndrome
NCT01817166
POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler
NCT01051817
Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis
NCT00097331
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MD1003
MD1003 100mg capsule, 1 capsule TID for 12 months
MD1003 100mg capsule
Placebo
Placebo capsule, 1 capsule TID for 6 months, then switch to MD1003 100mg capsule, 1 capsule TID for 6 months
MD1003 100mg capsule
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MD1003 100mg capsule
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Uni-or bilateral optic neuropathy with worst eye VA≤ 5/10 confirmed at 6 months
3. Worsening of visual acuity during the last three years
4. Informed consent prior to any study procedure
5. Patient aged 18-75 years
Exclusion Criteria
2. Normal RNFL at OCT
3. Presence of other ocular pathology (glaucoma, cataract, retinopathy, anterior uveitis, myopia\>7 dioptrics, intraocular pressure\>20 mm Hg, amblyopia, retinal or optic head abnormalities (drusen, tilted disc)
4. Bilateral visual acuity \<1/20
5. Visual impairment caused by ocular flutter or nystagmus
6. Pregnancy or childbearing potential woman without contraception
7. Any general chronic handicapping disease other than MS
8. New treatment introduced less than 3 months prior to inclusion or less than 1 month for Fampridine
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MedDay Pharmaceuticals SA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ayman Tourbah, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hopital Maison Blanche
Frederic Sedel, MD, PhD
Role: STUDY_DIRECTOR
MedDay Pharmaceuticals SA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hopital Pellegrin
Bordeaux, , France
Hopital de la cote de Nacre
Caen, , France
Hopital Gabriel Montpied
Clermont-Ferrand, , France
Hopital general du Bocage
Dijon, , France
CHRU de Lille
Lille, , France
Hopital Pierre Wertheimer
Lyon, , France
Hopital de la Timone
Marseille, , France
Hopital Gui de Chauliac
Montpellier, , France
Hopital Central
Nancy, , France
Hopital Nord Laennec
Nantes, , France
Hopital Pasteur
Nice, , France
Centre hospitalier national d'ophtalmologie des Quinze Vingts
Paris, , France
Groupe hospitalier la Pitie-Salpetriere
Paris, , France
Fondation Rothschild
Paris, , France
Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye
Poissy, , France
Hopital Maison Blanche
Reims, , France
Hopital Pontchaillou
Rennes, , France
Hopital de Hautepierre
Strasbourg, , France
Hopital Purpan
Toulouse, , France
UCL Institute of Neurology
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Tourbah A, Gout O, Vighetto A, Deburghgraeve V, Pelletier J, Papeix C, Lebrun-Frenay C, Labauge P, Brassat D, Toosy A, Laplaud DA, Outteryck O, Moreau T, Debouverie M, Clavelou P, Heinzlef O, De Seze J, Defer G, Sedel F, Arndt C. MD1003 (High-Dose Pharmaceutical-Grade Biotin) for the Treatment of Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Study. CNS Drugs. 2018 Jul;32(7):661-672. doi: 10.1007/s40263-018-0528-2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-002112-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MD1003CT2013-01MS-ON
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.