Effect of MD1003 in Spinal Progressive Multiple Sclerosis
NCT ID: NCT02220933
Last Updated: 2017-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
144 participants
INTERVENTIONAL
2013-10-31
2018-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MD1003
MD1003 100mg capsules, 1 capsule tid for 24 months
MD1003 100mg capsule
Placebo
Placebo capsule, 1 capsule tid for 12 months, then switch to MD1003 100mg capsule, 1 capsule tid for 12 months
MD1003 100mg capsule
Placebo
Interventions
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MD1003 100mg capsule
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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."
18 Years
75 Years
ALL
No
Sponsors
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MedDay Pharmaceuticals SA
INDUSTRY
Responsible Party
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Principal Investigators
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Ayman Tourbah, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hopital Maison Blanche, Reims, France
Frederic Sedel, MD, PhD
Role: STUDY_DIRECTOR
Medday SAS, Paris, France
Locations
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Hopital Pellegrin
Bordeaux, , France
Hopital de la cote de Nacre
Caen, , France
Hopital Gabriel Montpied
Clermont-Ferrand, , France
Hopital general du Bocage
Dijon, , France
Hopital Pierre Wertheimer
Lyon, , France
Hopital de la Timone
Marseille, , France
Hopital Gui de Chauliac
Montpellier, , France
Hopital Central
Nancy, , France
Hopital Nord Laennec
Nantes, , France
Hopital Pasteur
Nice, , France
Groupe hospitalier la Pitié-Salpêtrière
Paris, , France
Fondation Rothschild
Paris, , France
Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye
Poissy, , France
Hopital Maison Blanche
Reims, , France
Hopital Pontchaillou
Rennes, , France
Hopital Hautepierre
Strasbourg, , France
Hopital Purpan
Toulouse, , France
Countries
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Other Identifiers
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2013-002113-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MD1003CT2013-02MS-SPI
Identifier Type: -
Identifier Source: org_study_id
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