- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02220933
Effect of MD1003 in Spinal Progressive Multiple Sclerosis (MS-SPI)
Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Bordeaux, France, 33000
- Hôpital Pellegrin
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Caen, France, 14000
- Hôpital de la Côte de Nacre
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Clermont Ferrand, France, 63000
- Hôpital Gabriel Montpied
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Dijon, France, 21000
- Hopital general du Bocage
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Lyon, France, 69000
- Hopital Pierre Wertheimer
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Marseille, France, 13000
- Hôpital de la Timone
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Montpellier, France, 34000
- Hopital Gui de Chauliac
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Nancy, France, 54000
- Hôpital Central
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Nantes, France, 44000
- Hôpital Nord Laennec
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Nice, France, 06000
- Hopital PASTEUR
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Paris, France, 75019
- Fondation Rothschild
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Paris, France, 75013
- Groupe Hospitalier La Pitie-Salpetriere
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Poissy, France, 78300
- Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye
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Reims, France, 51000
- Hôpital Maison Blanche
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Rennes, France, 35000
- Hôpital Pontchaillou
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Strasbourg, France, 67000
- Hôpital Hautepierre
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Toulouse, France, 31000
- Hopital Purpan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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."
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MD1003
MD1003 100mg capsules, 1 capsule tid for 24 months
|
|
Placebo Comparator: Placebo
Placebo capsule, 1 capsule tid for 12 months, then switch to MD1003 100mg capsule, 1 capsule tid for 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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) 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) |
up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 12 months, 24 months
|
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). |
12 months, 24 months
|
Unidimensional Fatigue Impact Scale (U-FIS)
Time Frame: Baseline, 12 months, 24 months
|
The U-FIS has 22-items measuring the impact of fatigue.
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Baseline, 12 months, 24 months
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Multiple Sclerosis Quality of Life Scale (SEP-59)
Time Frame: Baseline, 12 months, 24 months
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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.
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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
|
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.
|
Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline, 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayman Tourbah, MD, PhD, Hôpital Maison Blanche, Reims, France
- Study Director: Frederic Sedel, MD, PhD, Medday SAS, Paris, France
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD1003CT2013-02MS-SPI
- 2013-002113-35 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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