Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, MS, EDSS
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.
Interventions
DRUGPlacebo
Sponsors
MedDay Pharmaceuticals SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients improved on either Expanded Disability Status Scale (EDSS) or time to walk 25 feet (TW25) | 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) or \- 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multiple Sclerosis Walking Scale (MSWS) | 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) | 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). |
| Multiple Sclerosis Quality of Life Scale (SEP-59) | 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) | 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. |
| Unidimensional Fatigue Impact Scale (U-FIS) | Baseline, 12 months, 24 months | The U-FIS has 22-items measuring the impact of fatigue. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Brain MRI | 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. |
Countries
France
Outcome results
None listed