Clinical trial NCT02220244: Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis
Official title: Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis (MS)
optic neuritis
visual defect
visual loss
relapsing remitting multiple sclerosis (RRMS)
primary progressive multiple sclerosis (PPMS)
secondary progressive multiple sclerosis (SPMS)
Lead sponsor: MedDay Pharmaceuticals SA
Sponsor class: INDUSTRY
First posted: 2014-08-19
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of the best corrected visual acuity at 100% contrast
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Visual field mean deviation change from baseline
timeFrame: Baseline, 6 months, 12 months
measure: Reappearance or improvement of the P00 wave on Visual Evoked Potential
timeFrame: Baseline, 6 months, 12 months
measure: Optical Coherence Tomography
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hopital Pellegrin
city: Caen
country: France
facility: Hopital de la cote de Nacre
city: Clermont Ferrand
country: France
facility: Hopital Gabriel Montpied
city: Dijon
country: France
facility: Hopital general du Bocage
city: Lille
country: France
facility: CHRU de Lille
city: Lyon
country: France
facility: Hopital Pierre Wertheimer
city: Marseille
country: France
facility: Hopital de la Timone
city: Montpellier
country: France
facility: Hopital Gui de Chauliac
city: Nancy
country: France
facility: Hopital Central
city: Nantes
country: France
facility: Hopital Nord Laennec
city: Nice
country: France
facility: Hopital Pasteur
city: Paris
country: France
facility: Centre hospitalier national d'ophtalmologie des Quinze Vingts
city: Paris
country: France
facility: Groupe hospitalier la Pitie-Salpetriere
city: Paris
country: France
facility: Fondation Rothschild
city: Poissy
country: France
facility: Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye
city: Reims
country: France
facility: Hopital Maison Blanche
city: Rennes
country: France
facility: Hopital Pontchaillou
city: Strasbourg
country: France
facility: Hopital de Hautepierre
city: Toulouse
country: France
facility: Hopital Purpan
city: London
country: United Kingdom
facility: UCL Institute of Neurology
Study officials:
affiliation: Hopital Maison Blanche
name: Ayman Tourbah, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MedDay Pharmaceuticals SA
name: Frederic Sedel, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.