Effect of MD1003 in Spinal Progressive Multiple Sclerosis

Launched by MEDDAY PHARMACEUTICALS SA · Aug 19, 2014

Keywords

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Gender

ALL

Eligibility criteria

• 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."