Effect of MD1003 in Progressive Multiple Sclerosis (SPI2) (SPI2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02936037|
Recruitment Status : Active, not recruiting
First Posted : October 18, 2016
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: MD1003 100mg capsule Drug: PLACEBO||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||642 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Total duration of Part 1 is 27 months. The randomized double-blind placebo-controlled period ranges from 15 to 27 months depending upon the randomization date of an individual patient.
Once the last month 15 evaluation of the study has been completed, patients will switch to the active drug at the next planned visit. Participants and study personnel will remain blinded as to the original treatment assignment.
Maximum duration of double-blind period per patient will be no longer than 27 months.
At the last evaluation of Part 1 (Visit 11/Month 27) all participants will be offered active treatment in an open label extension for 39 additional months (From V11/M27 to V18/M66).
The purpose of the active drug extension is to further define the safety of MD1003.
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of MD1003 in Progressive Multiple Sclerosis: a Randomized Double Blind Placebo Controlled Study|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||June 2023|
Placebo Comparator: GROUP 1
Placebo capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.
an inactive substance
Experimental: GROUP 2
MD1003 capsule, 1 capsule tid (morning,noon and evening) for 15 months and up to 27 months.
Drug: MD1003 100mg capsule
Other Name: high dose biotin
- Proportion of patients improved on either Expanded Disability Status Scale (EDSS) or time to walk 25 feet (TW25) [ Time Frame: 15 months ]
Proportion of patients improved on either Expanded Disability Status Scale (EDSS) or time to walk 25 feet (TW25) :
- with decreased EDSS at M12 confirmed at M15 (where decreased EDSS is defined as a decrease of at least 1 point if initial EDSS from 3.5 to 5.5 and of at least 0.5 point if initial EDSS from 6 to 6.5)
- with improved TW25 of at least 20% at Month 12 and Month15
compared to the lowest of the two EDSS and TW25* scores among inclusion and randomization visits.
*The lowest TW25 value recorded among the four values obtained during the inclusion and randomization visits will be considered as the baseline TW25 value.
- Time to 12-Weeks Confirmed EDSS progression [ Time Frame: 3 to 27 months ]
12-weeks EDSS progression is defined by an increase of at least 1 point for baseline EDSS 3.5 to 5.5 and of at least 0.5 point for baseline EDSS 6 to 6.5 with respective confirmation 12 weeks later.
Date of 12-weeks confirmed EDSS progression will be the first date of an EDSS progression (as defined above) that is confirmed 12 weeks later.
- CGI-I score (clinical global impression of change - improvement), evaluated both by the patient (SGI) and by the evaluating physician (CGI) [ Time Frame: 15 months ]
- Mean change in TW25 between M0 and M15 [ Time Frame: 15 months ]
- Brain MRI changes between M0 and M15 [ Time Frame: 15 months ]
- Remote monitoring of ambulation [ Time Frame: 27 months ]
- (MSQOL54) & (CAREQOL-MS) subscores and composite scores [ Time Frame: 15 months ]
- Subscores of the Kurtzke functional score [ Time Frame: 15 months ]
- Symbol digit modalities test (SDMT) [ Time Frame: 15 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936037
|Principal Investigator:||Bruce Cree, MD, PHD||University of California, San Francisco|
|Study Director:||Frederic Sedel, MD, PHD||Medday Pharmaceuticals|