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

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MD1003 100mg capsule
Sponsored by
MedDay Pharmaceuticals SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis (MS), optic neuritis, visual defect, visual loss, relapsing remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (SPMS)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Pellegrin
  • Hopital de la cote de Nacre
  • Hopital Gabriel Montpied
  • Hopital general du Bocage
  • CHRU de Lille
  • Hopital Pierre Wertheimer
  • Hopital de la Timone
  • Hopital Gui de Chauliac
  • Hopital Central
  • Hopital Nord Laennec
  • Hopital Pasteur
  • Centre hospitalier national d'ophtalmologie des Quinze Vingts
  • Groupe hospitalier la Pitie-Salpetriere
  • Fondation Rothschild
  • Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye
  • Hopital Maison Blanche
  • Hopital Pontchaillou
  • Hopital de Hautepierre
  • Hopital Purpan
  • UCL Institute of Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MD1003

Placebo

Arm Description

MD1003 100mg capsule, 1 capsule TID for 12 months

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

Outcomes

Primary Outcome Measures

Change from baseline of the best corrected visual acuity at 100% contrast
Best corrected visual acuity using the ETDRS logMar chart at 100% contrast

Secondary Outcome Measures

Visual field mean deviation change from baseline
Visual field analyses are performed using the standard automated perimetry method
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
Optical Coherence Tomography
Values of RNFL thickness and macular volume

Full Information

First Posted
August 18, 2014
Last Updated
March 23, 2017
Sponsor
MedDay Pharmaceuticals SA
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1. Study Identification

Unique Protocol Identification Number
NCT02220244
Brief Title
Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis
Acronym
MS-ON
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedDay Pharmaceuticals SA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MD1003
Arm Type
Experimental
Arm Description
MD1003 100mg capsule, 1 capsule TID for 12 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule, 1 capsule TID for 6 months, then switch to MD1003 100mg capsule, 1 capsule TID for 6 months
Intervention Type
Drug
Intervention Name(s)
MD1003 100mg capsule
Primary Outcome Measure Information:
Title
Change from baseline of the best corrected visual acuity at 100% contrast
Description
Best corrected visual acuity using the ETDRS logMar chart at 100% contrast
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Visual field mean deviation change from baseline
Description
Visual field analyses are performed using the standard automated perimetry method
Time Frame
Baseline, 6 months, 12 months
Title
Reappearance or improvement of the P00 wave on Visual Evoked Potential
Description
Two parameters will be evaluated: (1) presence of a clear P100 wave, (2) P100 latency
Time Frame
Baseline, 6 months, 12 months
Title
Optical Coherence Tomography
Description
Values of RNFL thickness and macular volume
Time Frame
Baseline, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Optic neuritis relapse within the three months before inclusion 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 New treatment introduced less than 3 months prior to inclusion or less than 1 month for Fampridine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman Tourbah, MD, PhD
Organizational Affiliation
Hopital Maison Blanche
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frederic Sedel, MD, PhD
Organizational Affiliation
MedDay Pharmaceuticals SA
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hopital de la cote de Nacre
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Hopital Gabriel Montpied
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Hopital general du Bocage
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hopital Pierre Wertheimer
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Hopital de la Timone
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Hopital Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Hopital Central
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Hopital Nord Laennec
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Hopital Pasteur
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Centre hospitalier national d'ophtalmologie des Quinze Vingts
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Groupe hospitalier la Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Fondation Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye
City
Poissy
ZIP/Postal Code
78300
Country
France
Facility Name
Hopital Maison Blanche
City
Reims
ZIP/Postal Code
51000
Country
France
Facility Name
Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Hopital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Hopital Purpan
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
UCL Institute of Neurology
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29808469
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.
Results Reference
derived
Links:
URL
http://medday-pharma.com
Description
Related Info

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

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