Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis

Phase 3

• Conditions: Multiple Sclerosis
• Interventions: Drug: MD1003 100mg capsule

• Registration Number: NCT02220244
• Lead Sponsor: MedDay Pharmaceuticals SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-08-18
• Study First Submitted QC: 2014-08-18
• Study First Posted: 2014-08-19
• Primary Completion: 2015-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-27
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MD1003	MD1003 100mg capsule	MD1003 100mg capsule, 1 capsule TID for 12 months
Placebo	MD1003 100mg capsule	Placebo capsule, 1 capsule TID for 6 months, then switch to MD1003 100mg capsule, 1 capsule TID for 6 months

Primary Outcome Measures

Name	Time	Method
Change from baseline of the best corrected visual acuity at 100% contrast	Baseline, 6 months	Best corrected visual acuity using the ETDRS logMar chart at 100% contrast

Secondary Outcome Measures

Name	Time	Method
Visual field mean deviation change from baseline	Baseline, 6 months, 12 months	Visual field analyses are performed using the standard automated perimetry method
Reappearance or improvement of the P00 wave on Visual Evoked Potential	Baseline, 6 months, 12 months	Two parameters will be evaluated: (1) presence of a clear P100 wave, (2) P100 latency
Optical Coherence Tomography	Baseline, 6 months, 12 months	Values of RNFL thickness and macular volume

Trial Locations

Locations (20)

Hopital Pontchaillou; 🇫🇷 Rennes, France

Hopital Pierre Wertheimer; 🇫🇷 Lyon, France

UCL Institute of Neurology; 🇬🇧 London, United Kingdom

Hopital Pellegrin; 🇫🇷 Bordeaux, France

Hopital general du Bocage; 🇫🇷 Dijon, France

Hopital de la Timone; 🇫🇷 Marseille, France

Hopital de la cote de Nacre; 🇫🇷 Caen, France

Centre hospitalier national d'ophtalmologie des Quinze Vingts; 🇫🇷 Paris, France

CHRU de Lille; 🇫🇷 Lille, France

Hopital Gui de Chauliac; 🇫🇷 Montpellier, France

Hopital Gabriel Montpied; 🇫🇷 Clermont Ferrand, France

Hopital Nord Laennec; 🇫🇷 Nantes, France

Hopital Pasteur; 🇫🇷 Nice, France

Groupe hospitalier la Pitie-Salpetriere; 🇫🇷 Paris, France

Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye; 🇫🇷 Poissy, France

Hopital Maison Blanche; 🇫🇷 Reims, France

Fondation Rothschild; 🇫🇷 Paris, France

Hopital Purpan; 🇫🇷 Toulouse, France

Hopital Central; 🇫🇷 Nancy, France

Hopital de Hautepierre; 🇫🇷 Strasbourg, France