Informations générales (source: ClinicalTrials.gov)
Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study (MS-SPI)
Interventional
Phase 3
MedDay Pharmaceuticals SA (Voir sur ClinicalTrials)
octobre 2013
janvier 2018
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI POISSY ST-GERMAIN | Contact (sur clinicalTrials) | ||||
| HOPITAL FONDATION A. DE ROTHSCHILD | vendredi 21 juin 2024 | Contact (sur clinicalTrials) | |||
| IFSI DU GROUPE HOSP. PITIÉ SALPÉTRIÈRE | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hopital Central - 54000 - Nancy - France | Contact (sur clinicalTrials) | ||||
| Hopital de la cote de Nacre - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
| Hopital Gabriel Montpied - 63000 - Clermont Ferrand - France | Contact (sur clinicalTrials) | ||||
| Hopital general du Bocage - 21000 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Hopital Gui de Chauliac - 34000 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Hopital Hautepierre - 67000 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Hopital Maison Blanche - 51000 - Reims - France | Contact (sur clinicalTrials) | ||||
| Hopital Nord Laennec - 44000 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Hopital Pasteur - 06000 - Nice - France | Contact (sur clinicalTrials) | ||||
| Hopital Pellegrin - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Hopital Pierre Wertheimer - 69000 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hopital Purpan - 31000 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hopital de la Timone - 13000 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Hopital Pontchaillou - 35000 - Rennes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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."