Multiple Sclerosis Clinical Trial
— MS-ONOfficial title:
Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked Placebo Controlled Study
| Verified date | March 2017 |
| Source | MedDay Pharmaceuticals SA |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 105 |
| Est. completion date | January 2018 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 | Fondation Rothschild | Paris | |
| France | Groupe hospitalier la Pitie-Salpetriere | 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 | |
| United Kingdom | UCL Institute of Neurology | London |
| Lead Sponsor | Collaborator |
|---|---|
| MedDay Pharmaceuticals SA |
France, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline of the best corrected visual acuity at 100% contrast | Best corrected visual acuity using the ETDRS logMar chart at 100% contrast | Baseline, 6 months | |
| Secondary | Visual field mean deviation change from baseline | Visual field analyses are performed using the standard automated perimetry method | Baseline, 6 months, 12 months | |
| Secondary | Reappearance or improvement of the P00 wave on Visual Evoked Potential | Two parameters will be evaluated: (1) presence of a clear P100 wave, (2) P100 latency | Baseline, 6 months, 12 months | |
| Secondary | Optical Coherence Tomography | Values of RNFL thickness and macular volume | Baseline, 6 months, 12 months |
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