This trial is active, not recruiting.

Condition multiple sclerosis
Treatment md1003 100mg capsule
Phase phase 3
Sponsor Medday SAS
Start date October 2013
End date December 2015
Trial size 105 participants
Trial identifier NCT02220244, 2013-002112-27, MD1003CT2013-01MS-ON


The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the visual improvement of patients suffering from chronic visual loss resulting from multiple sclerosis related optic neuritis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
MD1003 100mg capsule, 1 capsule TID for 12 months
md1003 100mg capsule
(Placebo Comparator)
Placebo capsule, 1 capsule TID for 6 months, then switch to MD1003 100mg capsule, 1 capsule TID for 6 months
md1003 100mg capsule

Primary Outcomes

Change from baseline of the best corrected visual acuity at 100% contrast
time frame: Baseline, 6 months

Secondary Outcomes

Visual field mean deviation change from baseline
time frame: Baseline, 6 months, 12 months
Reappearance or improvement of the P00 wave on Visual Evoked Potential
time frame: Baseline, 6 months, 12 months
Optical Coherence Tomography
time frame: Baseline, 6 months, 12 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: 1. Diagnosis criteria of MS fulfilling revised Mc Donald criteria (2010) 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: 1. Optic neuritis relapse within the three months before inclusion 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

Additional Information

Official title Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked Placebo Controlled Study
Principal investigator Ayman Tourbah, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Medday SAS.