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| Sponsored by: |
Teva Pharmaceutical Industries |
| Information provided by: | Teva Pharmaceutical Industries |
| ClinicalTrials.gov Identifier: | NCT00203086 |
Purpose
It is thought that treating Multiple Sclerosis with Novantrone for a short period of time prior to treatment with Copaxone may enhance the onset effect of Copaxone.
| Condition | Intervention | Phase |
|
Relapse Remitting Multiple Sclerosis |
Drug: glatiramer acetate Drug: mitoxantrone |
Phase IV |
| MedlinePlus related topics: | Multiple Sclerosis |
| Drug Information available for: | Mitoxantrone hydrochloride Mitoxantrone Copolymer 1 |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | A Multi-Centered, Two Arm, Open Label Extension Study (to Protocol NC-100) to Evaluate the Long-Term Safety and Efficacy of Short-Term Induction Treatment With Mitoxantrone (Novantrone®) Preceding Treatment With Glatiramer Acetate (Copaxone®) vs. Chronic Treatment With Glatiramer Acetate Alone in Relapsing Forms of Multiple Sclerosis |
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2005 |
| Study Completion Date: | December 2007 |
Multi-centered, follow-up safety and efficacy study with clinic visits at 24 and 36 months. Subjects completing the NC-100 clinical trial will be treated per the physician's usual clinical practice which may involve use of prescribed commercial products® administered in accordance with prescribing information
Eligibility
| Ages Eligible for Study: | 20 Years to 57 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| United States, Arizona | |||||
| Barrow Neurological Institute | |||||
| Phoenix, Arizona, United States, 85013 | |||||
| United States, Vermont | |||||
| University of Vermont | |||||
| Burlington, Vermont, United States, 05401 | |||||
| Canada, Quebec | |||||
| Montreal Neurological Institute and Hospital | |||||
| Montreal, Quebec, Canada, H3A 2B4 | |||||
| Teva Pharmaceutical Industries |
| Study Director: | Lillian Pardo, MD | Teva Neuroscience, Inc. |
More Information
For more information about Multiple Sclerosis
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For more information about Teva Neuroscience
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| Study ID Numbers: | PM 025 |
| First Received: | September 13, 2005 |
| Last Updated: | September 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00203086 |
| Health Authority: | United States: Food and Drug Administration; Canada: Therapeutics Products Directorate |
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