MS-ON
What it found
The main measure did not show a significant benefit.
“The study did not meet its primary endpoint, as the mean change in the primary endpoint was nonsignificantly larger (p = 0.66) with MD1003 (- 0.061 logMAR, + 3.1 letters) than with placebo (- 0.036 logMAR, + 1.8 letters).”Read by software from the paper's abstract
month 6
| Group | n | Value |
|---|---|---|
| MD1003 | 65 | - 0.061 logMAR, + 3.1 letters |
| Placebo | 28 | - 0.036 logMAR, + 1.8 letters |
p = 0.66
Read by software from the paper's abstract
What was tested
Treatment tested
- MD1003 100mg capsule
- Biotin
What it measured
Main measures
Change from baseline of the best corrected visual acuity at 100% contrast
Baseline, 6 months
VisionMean change in best corrected visual acuity (logMAR) at 100% contrast between baseline and month 6 of the diseased eye (where the diseased eye is defined as the eye with the worst visual acuity (<5/10) at baseline and with evidence of worsening during the past three years)
Vision
Other measures (4)
Visual field mean deviation change from baseline
Baseline, 6 months, 12 months
Reappearance or improvement of the P00 wave on Visual Evoked Potential
Baseline, 6 months, 12 months
Myelin repairOptical Coherence Tomography
Baseline, 6 months, 12 months
Retina scans (OCT)1. A Fisher’s exact test will be used to compare the proportions of patients with improvement of VA of the diseased eye of at least 0.3 logMAR at M6
Who could take part
Relapsing and progressive · 18 to 75
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Effects of Phenytoin on the Retinal Ganglion Cell-Inner Plexiform Layer in Acute Optic Neuritis: Analysis of a Phase II Randomized Trial.Neurology · 2025
Results
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
The study did not meet its primary endpoint, as the mean change in the primary endpoint was nonsignificantly larger (p = 0.66) with MD1003 (- 0.061 logMAR, + 3.1 letters) than with placebo (- 0.036 logMAR, + 1.8 letters).
Read by software from the paper's abstract
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History
Started
Oct 2013
Main results due
Dec 2015
Finished
Jan 2018
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