BIP_Sage PPMC 547-SSE-301
BIP Sage PPMC 547-SSE-301-A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects with Super-Refractory Status Epilepticus
The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the disability of patients suffering from progressive multiple sclerosis and especially those with gait impairment.
-Patients aged 18-65 years old with diagnosis of primary or secondary progressive MS (PPMS or SPMS) with documented evidence of clinical disability progression within the 2 years prior to inclusion.
Key Exclusion Criteria:
-Clinical evidence of a relapse in 24 months prior to inclusion.
-Treatment with any product containing biotin as single ingredient within six months prior to inclusion (multivitamin supplementation authorized if biotin < 1mg per day).
-Concomitant treatment with fampridine at inclusion or in the 30 days prior to inclusion.
-New immunosuppressive/immunomodulatory drug initiated less than 90 days prior to inclusion.
-Treatment with botulinium toxin (except for cosmetic purpose) initiated within 6 months prior to inclusion.
**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Evan Fertig, M.D.
- Providence Portland Medical Center