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

NCT02220244 | Unknown Phase 3 DMC

• 2 other identifiers: MD1003CT2013-01MS-ON2013-002112-27
• Study Type: interventional
• Target: 105
• Locations: 2 countries
• Sites: 20

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Optical Coherence Tomography

  Baseline, 6 months, 12 months

Study Arms (2)

MD1003

EXPERIMENTAL

MD1003 100mg capsule, 1 capsule TID for 12 months

Drug: MD1003 100mg capsule

Placebo

PLACEBO COMPARATOR

Placebo capsule, 1 capsule TID for 6 months, then switch to MD1003 100mg capsule, 1 capsule TID for 6 months

Drug: MD1003 100mg capsule

Interventions

MD1003 100mg capsule DRUG

MD1003; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis criteria of MS fulfilling revised Mc Donald criteria (2010)
• Uni-or bilateral optic neuropathy with worst eye VA≤ 5/10 confirmed at 6 months
• Worsening of visual acuity during the last three years
• Informed consent prior to any study procedure
• Patient aged 18-75 years

You may not qualify if:

• Normal RNFL at OCT
• 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)
• Bilateral visual acuity \<1/20
• Visual impairment caused by ocular flutter or nystagmus
• Pregnancy or childbearing potential woman without contraception
• Any general chronic handicapping disease other than MS

Sponsors & Collaborators

• MedDay Pharmaceuticals SA: lead

Study Sites (20)

Hopital Pellegrin

Bordeaux, 33000, France

Location

Hopital de la cote de Nacre

Caen, 14000, France

Location

Hopital Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

Hopital general du Bocage

Dijon, 21000, France

Location

CHRU de Lille

Lille, 59000, France

Location

Hopital Pierre Wertheimer

Lyon, 69000, France

Location

Hopital de la Timone

Marseille, 13000, France

Location

Hopital Gui de Chauliac

Montpellier, 34000, France

Location

Hopital Central

Nancy, 54000, France

Location

Hopital Nord Laennec

Nantes, 44000, France

Location

Hopital Pasteur

Nice, 06000, France

Location

Centre hospitalier national d'ophtalmologie des Quinze Vingts

Paris, 75012, France

Location

Groupe hospitalier la Pitie-Salpetriere

Paris, 75013, France

Location

Fondation Rothschild

Paris, 75019, France

Location

Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye

Poissy, 78300, France

Location

Hopital Maison Blanche

Reims, 51000, France

Location

Hopital Pontchaillou

Rennes, 35000, France

Location

Hopital de Hautepierre

Strasbourg, 67000, France

Location

Hopital Purpan

Toulouse, 31000, France

Location

UCL Institute of Neurology

London, WC1N 3BG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29808469 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Optic Neuritis; Vision Disorders; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Ayman Tourbah, MD, PhD

  Hopital Maison Blanche

  PRINCIPAL INVESTIGATOR

• Frederic Sedel, MD, PhD

  MedDay Pharmaceuticals SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 19, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2018
• Last Updated: March 27, 2017

Record last verified: 2017-03

Locations

FR (19); GB (1)