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Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis (MS-ON)

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ClinicalTrials.gov Identifier: NCT02220244
Recruitment Status : Active, not recruiting
First Posted : August 19, 2014
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
MedDay Pharmaceuticals SA

August 18, 2014
August 19, 2014
March 27, 2017
October 2013
December 2015   (Final data collection date for primary outcome measure)
Change from baseline of the best corrected visual acuity at 100% contrast [ Time Frame: Baseline, 6 months ]
Best corrected visual acuity using the ETDRS logMar chart at 100% contrast
Same as current
Complete list of historical versions of study NCT02220244 on ClinicalTrials.gov Archive Site
  • Visual field mean deviation change from baseline [ Time Frame: 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 [ Time Frame: Baseline, 6 months, 12 months ]
    Two parameters will be evaluated: (1) presence of a clear P100 wave, (2) P100 latency
  • Optical Coherence Tomography [ Time Frame: Baseline, 6 months, 12 months ]
    Values of RNFL thickness and macular volume
Same as current
Not Provided
Not Provided
 
Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis
Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked Placebo Controlled Study
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis
Drug: MD1003 100mg capsule
  • Experimental: MD1003
    MD1003 100mg capsule, 1 capsule TID for 12 months
    Intervention: Drug: MD1003 100mg capsule
  • Placebo Comparator: Placebo
    Placebo capsule, 1 capsule TID for 6 months, then switch to MD1003 100mg capsule, 1 capsule TID for 6 months
    Intervention: Drug: MD1003 100mg capsule
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 Sèze 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
105
Same as current
January 2018
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France,   United Kingdom
 
 
NCT02220244
MD1003CT2013-01MS-ON
2013-002112-27 ( EudraCT Number )
Yes
Not Provided
Not Provided
MedDay Pharmaceuticals SA
MedDay Pharmaceuticals SA
Not Provided
Principal Investigator: Ayman Tourbah, MD, PhD Hopital Maison Blanche
Study Director: Frederic Sedel, MD, PhD MedDay Pharmaceuticals SA
MedDay Pharmaceuticals SA
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP