Effect of MD1003 in chronic visual loss related to optic neuritis in multiplesclerosis: a pivotal randomized double masked placebo controlled study - MS-O

MEDDAY Pharmaceuticals SA0 个研究点目标入组 105 人开始时间: 2015年8月7日最近更新: 2017年7月3日

适应症

试验速览

暂无简介。

•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

发起方

MEDDAY Pharmaceuticals SA