Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis
NCT ID: NCT00219908
Last Updated: 2005-12-22
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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TERMINATED
PHASE2
124 participants
INTERVENTIONAL
1999-07-31
2006-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Interventions
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Mitoxantrone
Eligibility Criteria
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Inclusion Criteria
* Clinical disease satisfying the Poser criteria (Amdmt n°4)
* relapsing-remitting disease (Amdmt N°4)
* at least 2 exacerbations within the preceding 12 months, having left sequelae,
* MRI activity at inclusion expressed by at least one gadolinium-enhanced lesion (cranial MRI with 0.1mmol/kg gadolinium),
* a significant disability at inclusion: EDSS score between 2.5 and 5.5 (Amdt N° 4)
* written informed consent
Exclusion Criteria
* use of an insufficiency effective contraceptive method,
* general immunosuppressive therapy using cyclophosphamide, mitoxantrone,or total lymphoid irradiation
* treatment with azathioprine during the 3 months preceding the study
* clinical relapse or intensive corticosteroid treatment within the 30 days preceding inclusion,
* associated disease (psychiatric disorder, depressive statenot controlled by appropriate drug therapy, history of heart disease at inclusion examination
18 Years
45 Years
No
Sponsors
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Bayer
INDUSTRY
Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Farmades, Italy
UNKNOWN
Rennes University Hospital
OTHER
Principal Investigators
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Gilles EDAN, Professor
Role: STUDY_DIRECTOR
CHU Rennes
Locations
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Hôpital Cote de Nacre
Caen, , France
Hôpital Gabriel Montpied
Clermont-Ferrand, , France
CHU Henri Mondor
Créteil, , France
Hôpital Général
Dijon, , France
CHU Limoges
Limoges, , France
Institut Catholique de Lille
Lomme, , France
Pierre Weitheimer Hospital
Lyon, , France
Chu Timone
Marseille, , France
Centre Guy de Chauliac
Montpellier, , France
CHU Hôpital Central
Nancy, , France
CHU
Nice, , France
CHU Pitié-Salpétrière
Paris, , France
Hôpital Saint-Anne
Paris, , France
Centre Fondation Rotschild
Paris, , France
Tenon Hospital
Paris, , France
CHU Strasbourg
Strasbourg, , France
CHU Purpan
Toulouse, , France
Psichiatriche dell'Università di Bari, Policlinico
Bari, , Italy
Dipartimento di Scienze Neurologiche e Psichiatriche
Florence, , Italy
Hospedal Civile
Gallarate, , Italy
Neuroriabilitazione dell'Università
Genova, , Italy
Fondazionz SAN Raffaele del monte tabor
Milan, , Italy
Clinica Neurologica Università di Torino
Torino, , Italy
Countries
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Other Identifiers
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981166
Identifier Type: -
Identifier Source: org_study_id