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Multiple SclerosisPhase 3MS-ONNCT02220244

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

A Phase 3 study testing MD1003 100mg capsule in people with Multiple Sclerosis, run by MedDay Pharmaceuticals SA at 20 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
MD1003 100mg capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
20 sitesin 2 countries
Study dates
Oct 2013to Jan 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

20 sites in 2 countries.

20 sites in 2 countries

France19 sites

  • Hopital Pellegrin

    Bordeaux, 33000

  • Hopital de la cote de Nacre

    Caen, 14000

  • Hopital Gabriel Montpied

    Clermont-Ferrand, 63000

  • Hopital general du Bocage

    Dijon, 21000

  • CHRU de Lille

    Lille, 59000

  • Hopital Pierre Wertheimer

    Lyon, 69000

  • Hopital de la Timone

    Marseille, 13000

  • Hopital Gui de Chauliac

    Montpellier, 34000

  • Hopital Central

    Nancy, 54000

  • Hopital Nord Laennec

    Nantes, 44000

  • Hopital Pasteur

    Nice, 06000

  • Centre hospitalier national d'ophtalmologie des Quinze Vingts

    Paris, 75012

  • Groupe hospitalier la Pitie-Salpetriere

    Paris, 75013

  • Fondation Rothschild

    Paris, 75019

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

    Poissy, 78300

  • Hopital Maison Blanche

    Reims, 51000

  • Hopital Pontchaillou

    Rennes, 35000

  • Hopital de Hautepierre

    Strasbourg, 67000

  • Hopital Purpan

    Toulouse, 31000

Other trials in France

United Kingdom1 site

  • UCL Institute of Neurology

    London, WC1N 3BG

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
MD1003 100mg capsule
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)
Medical subject headings
Multiple Sclerosis, Optic Neuritis, Vision Disorders, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MD1003 100mg capsuleDrug

Study groups in NCT02220244
Study groupRoleWhat they receive
MD1003ExperimentalMD1003 100mg capsule, 1 capsule TID for 12 months
Receives: Drug: MD1003 100mg capsule
PlaceboPlacebo comparatorPlacebo capsule, 1 capsule TID for 6 months, then switch to MD1003 100mg capsule, 1 capsule TID for 6 months
Receives: Drug: MD1003 100mg capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline, 6 months

Secondary outcomes (3)

  1. Visual field mean deviation change from baseline

    Visual field analyses are performed using the standard automated perimetry method

    Measured: Baseline, 6 months, 12 months

  2. 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

    Measured: Baseline, 6 months, 12 months

  3. Optical Coherence Tomography

    Values of RNFL thickness and macular volume

    Measured: Baseline, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2014 (estimated)
  2. Study startOct 2013
  3. Primary completionDec 2015
  4. Study completionJan 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02220244
Sponsor's protocol ID
MD1003CT2013-01MS-ON
Other IDs
2013-002112-27
Acronym
MS-ON
Status last verified
Mar 2017
First submitted
18 Aug 2014
Last updated
27 Mar 2017
Results posted
No
Data monitoring committee
Yes

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 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.

    PubMed 29808469

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MD1003 100mg capsule in people with Multiple Sclerosis, run by MedDay Pharmaceuticals SA at 20 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline of the best corrected visual acuity at 100% contrast (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02220244, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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