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Trial record 1 of 1 for:    NCT02220244
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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 : Unknown
Verified March 2017 by MedDay Pharmaceuticals SA.
Recruitment status was:  Active, not recruiting
First Posted : August 19, 2014
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
MedDay Pharmaceuticals SA

Tracking Information
First Submitted Date  ICMJE August 18, 2014
First Posted Date  ICMJE August 19, 2014
Last Update Posted Date March 27, 2017
Actual Study Start Date  ICMJE October 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis
Official Title  ICMJE Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked Placebo Controlled Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Drug: MD1003 100mg capsule
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 18, 2014)
105
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2018
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02220244
Other Study ID Numbers  ICMJE MD1003CT2013-01MS-ON
2013-002112-27 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MedDay Pharmaceuticals SA
Study Sponsor  ICMJE MedDay Pharmaceuticals SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ayman Tourbah, MD, PhD Hopital Maison Blanche
Study Director: Frederic Sedel, MD, PhD MedDay Pharmaceuticals SA
PRS Account MedDay Pharmaceuticals SA
Verification Date March 2017

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