Status:
UNKNOWN
Effect of MD1003 in Spinal Progressive Multiple Sclerosis
Lead Sponsor:
MedDay Pharmaceuticals SA
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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."
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2018
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT02220933
Start Date
October 1 2013
End Date
January 1 2018
Last Update
March 27 2017
Active Locations (17)
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1
Hopital Pellegrin
Bordeaux, France, 33000
2
Hopital de la cote de Nacre
Caen, France, 14000
3
Hopital Gabriel Montpied
Clermont-Ferrand, France, 63000
4
Hopital general du Bocage
Dijon, France, 21000