Effect of MD1003 in Spinal Progressive Multiple Sclerosis (MS-SPI)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study|
- Proportion of patients improved on either Expanded Disability Status Scale (EDSS) or time to walk 25 feet (TW25) [ Time Frame: up to 24 months ]
Proportions of patients in each treatment arm:
- with decreased EDSS at M9 confirmed at Month12 (where decreased EDSS is defined as a decrease of at least 0.5 point if initial EDSS from 6 to 7 and a decrease of at least 1 point if initial EDSS from 4.5 to 5.5)
- with improved TW25 of at least 20% at Month 9 and Month12
compared to the best EDSS and TW25 scores among screening visit (Month-1) and randomization visit (baseline)
- Multiple Sclerosis Walking Scale (MSWS) [ Time Frame: Baseline, 12 months, 24 months ]The 12‐item multiple sclerosis walking scale (MSWS‐12) is a self‐report measure of the impact of MS on the individual's walking ability.
- Clinical Global Impression / Subject Global Impression (CGI / SGI) [ Time Frame: 12 months, 24 months ]
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
The clinical global impression will be assessed by the patient (subject global impression, SGI) and by the clinician (clinician global impression, CGI).
- Unidimensional Fatigue Impact Scale (U-FIS) [ Time Frame: Baseline, 12 months, 24 months ]The U-FIS has 22-items measuring the impact of fatigue.
- Multiple Sclerosis Quality of Life Scale (SEP-59) [ Time Frame: Baseline, 12 months, 24 months ]The SEP-59 is a multidimensional health-related quality of life measure that combines 36 generic items and 29 MS-specific items into a single instrument.
- Hole Peg Test (9-HPT) [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months ]The 9-HPT apparatus comprises a container with nine pegs and an empty pegboard with nine holes, set three by three. The pegs must be picked up one at a time and placed in the holes as quickly as possible until all holes are filled. Then, without pausing, the pegs should be removed one at a time, again as quickly as possible. This should be performed twice for each hand. If a peg falls onto the table, the peg should be picked up with the hand which is being tested. If a peg falls onto the floor, it is picked up by the examiner. The time is recorded in seconds, starting as the patient picks up the first peg and ending when the last peg drops into the container.
- Brain MRI [ Time Frame: Baseline, 12 months ]Brain MRI using at least T2 and T1 sequences with gadolinium injection will be performed in a subset of 72 patients i.e 24 in the placebo group and 48 in the treated group, at study onset and after 12 months. Safety of MD1003 will be assessed by comparing novel T2 hypersignals as well as T1 post-gadolinium enhancing lesions in the two groups.
|Actual Study Start Date:||October 2013|
|Estimated Study Completion Date:||January 2018|
|Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
MD1003 100mg capsules, 1 capsule tid for 24 months
|Drug: MD1003 100mg capsule|
Placebo Comparator: Placebo
Placebo capsule, 1 capsule tid for 12 months, then switch to MD1003 100mg capsule, 1 capsule tid for 12 months
|Drug: MD1003 100mg capsule Drug: Placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02220933
|Bordeaux, France, 33000|
|Hopital de la cote de Nacre|
|Caen, France, 14000|
|Hopital Gabriel Montpied|
|Clermont Ferrand, France, 63000|
|Hopital general du Bocage|
|Dijon, France, 21000|
|Hopital Pierre Wertheimer|
|Lyon, France, 69000|
|Hopital de la Timone|
|Marseille, France, 13000|
|Hopital Gui de Chauliac|
|Montpellier, France, 34000|
|Nancy, France, 54000|
|Hopital Nord Laennec|
|Nantes, France, 44000|
|Nice, France, 06000|
|Groupe hospitalier la Pitié-Salpêtrière|
|Paris, France, 75013|
|Paris, France, 75019|
|Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye|
|Poissy, France, 78300|
|Hopital Maison Blanche|
|Reims, France, 51000|
|Rennes, France, 35000|
|Strasbourg, France, 67000|
|Toulouse, France, 31000|
|Principal Investigator:||Ayman Tourbah, MD, PhD||Hopital Maison Blanche, Reims, France|
|Study Director:||Frederic Sedel, MD, PhD||Medday SAS, Paris, France|