Effect of MD1003 on visuel impairement of multiple sclerosis
- Conditions
- chronic visual loss related to optic neuritis in multiple sclerosisMedDRA version: 20.0Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10030942Term: Optic neuritisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-002112-27-GB
- Lead Sponsor
- MEDDAY Pharmaceuticals SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 105
1. Signed and dated written inform consent form in accordance with local regulations: having freely given their written informed consent to participate in the study.
2. Diagnosis criteria of MS fulfilling the actualised Mc Donald criteria (2010)
3. Uni-or bilateral optic neuropathy with worst eye VA= 5/10 confirmed at 6 months
4. Worsening of visual acuity during the last three years (at least 1/10 point)
5. Patient aged 18-75 years
6. Likely to be able to participate in all scheduled evaluations and complete all required study procedures.
7. In the opinion of the investigator, the patient will be compliant and have a high probability of completing the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1. Optic neuritis relapse within the three months before inclusion
2. Presence of other ocular pathology (glaucoma, cataract, retinopathy, anterior uveitis, myopia>7 d, intraocular pressure>20 mm Hg, amblyopia, retinal or optic head abnormalities (drusen, dysversion…)
3. Bilateral visual acuity <1/20
4. Visual impairment caused by ocular flutter or nystagmus
5. Patients with uncontrolled hepatic disorder, renal or cardiovascular disease, or cancer
6. Patients with hypersensitivity to biotin or MD1003’s excipients
7. Patients treated with any new medication for MS (immunomodulators, immunosuppressive) but fampridine, initiated less than 3 months prior to inclusion
8. Treatment with fampridine initiated less than 1 month prior to inclusion
9. Laboratory tests out of normal range according to the reference laboratory values. Deviations may be accepted if considered clinically insignificant for the conduct of study by the investigator,
10. Patients with history or presence of alcohol abuse or drug addiction,
11. Pregnant or breast-feeding women,
12. Women of childbearing age without effective contraception (oral pill or IUCD),
13. Patients likely to be non-compliant to the study procedures or for whom a long-term follow-up seems to be difficult to achieve.
14. Normal RNFL at OCT
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the superiority of biotin 300 mg/day over placebo in the<br>visual improvement of patients suffering from chronic visual loss after<br>optic neuritis related to multiple sclerosis;Secondary Objective: To evaluate the safety of high doses of Biotin;Primary end point(s): The primary endpoint is the mean change in best corrected visual acuity (logMAR) at 100% contrast between baseline and month 6 of the diseased eye (where the diseased eye is defined as the eye with the worst visual acuity (<5/10) at baseline and with evidence of worsening during the past three years).;Timepoint(s) of evaluation of this end point: The primary and secondary endpoints will be assessed both at the end of the placebo-controlled period (M6) and at the end of the extension phase (M12, M24, M36 and M48). During long term extension phase of 18 months, the visual acuity (ETDRS) will be assessed every 6 months.
- Secondary Outcome Measures
Name Time Method