This trial is active, not recruiting.

Condition multiple sclerosis
Treatments md1003 100mg capsule, placebo
Phase phase 3
Sponsor Medday SAS
Start date October 2013
End date January 2016
Trial size 144 participants
Trial identifier NCT02220933, 2013-002113-35, MD1003CT2013-02MS-SPI


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
MD1003 100mg capsules, 1 capsule tid for 24 months
md1003 100mg capsule
(Placebo Comparator)
Placebo capsule, 1 capsule tid for 12 months, then switch to MD1003 100mg capsule, 1 capsule tid for 12 months
md1003 100mg capsule

Primary Outcomes

Proportion of patients improved on either Expanded Disability Status Scale (EDSS) or time to walk 25 feet (TW25)
time frame: up to 24 months

Secondary Outcomes

Multiple Sclerosis Walking Scale (MSWS)
time frame: Baseline, 12 months, 24 months
Clinical Global Impression / Subject Global Impression (CGI / SGI)
time frame: 12 months, 24 months
Unidimensional Fatigue Impact Scale (U-FIS)
time frame: Baseline, 12 months, 24 months
Multiple Sclerosis Quality of Life Scale (SEP-59)
time frame: Baseline, 12 months, 24 months
Hole Peg Test (9-HPT)
time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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."

Additional Information

Official title Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study
Principal investigator Ayman Tourbah, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Medday SAS.