Title
Effect of MD1003 in Spinal Progressive Multiple Sclerosis
Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study
Phase
Phase 3Lead Sponsor
MedDay PharmaceuticalsStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Multiple SclerosisIntervention/Treatment
biotin ...Study Participants
144The 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.
Placebo capsule, 1 capsule tid for 12 months, then switch to MD1003 100mg capsule, 1 capsule tid for 12 months
Inclusion Criteria: Diagnosis criteria of secondary or primary progressive MS with clinical evidence of spastic paraparesis fulfilling revised McDonald criteria (2010) and Lublin criteria (1996) Progression of the EDSS during the past two years of at least 1 point if EDSS from 4.5 to 5.5 and at least 0.5 point if EDSS from 6 to 7 EDSS score from 4.5 to 7 (measured away from a relapse and confirmed at 6 months) Informed consent prior to any study procedure Patient aged 18-75 years Exclusion Criteria: Any general chronic handicapping disease other than MS Intensive physical therapy program within the 3 months prior to inclusion Impossibility to perform the TW25 test New treatment introduced less than 3 months prior to inclusion or less than 1 month for Fampridine Pregnancy or woman with childbearing potential without contraception Evidence of inflammatory activity of the disease defined as "clinical evidence of a relapse during the year before inclusion or evidence of new gadolinium-enhanced lesions on a brain MRI performed the year before inclusion."
