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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02220244 |
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Date of registration:
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18/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis
MS-ON |
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Scientific title:
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Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked Placebo Controlled Study |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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105 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02220244 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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France
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United Kingdom
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Contacts
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Name:
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Frederic Sedel, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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MedDay Pharmaceuticals SA |
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Name:
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Ayman Tourbah, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hopital Maison Blanche |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: MD1003 100mg capsule
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Primary Outcome(s)
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Change from baseline of the best corrected visual acuity at 100% contrast
[Time Frame: Baseline, 6 months]
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Secondary Outcome(s)
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Reappearance or improvement of the P00 wave on Visual Evoked Potential
[Time Frame: Baseline, 6 months, 12 months]
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Visual field mean deviation change from baseline
[Time Frame: Baseline, 6 months, 12 months]
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Optical Coherence Tomography
[Time Frame: Baseline, 6 months, 12 months]
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Secondary ID(s)
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MD1003CT2013-01MS-ON
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2013-002112-27
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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