A Study to Evaluate the Long Term Safety and Effectiveness of Novantrone Therapy Followed by Copaxone Treatment for Multiple Sclerosis
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00203086
Collaborator
(none)
30
50
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
30 participants
Observational Model:
Cohort
Time Perspective:
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
Study Start Date
:
Oct 1, 2005
Actual Primary Completion Date
:
Oct 1, 2009
Actual Study Completion Date
:
Dec 1, 2009
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 57 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participation & completion of the NC-100 Clinical Trial.
-
Able and willing to sign an Informed Consent.
Exclusion Criteria:
none
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
- Study Director: Lillian Pardo, MD, Teva Neuroscience, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00203086
Other Study ID Numbers:
- PM025
First Posted:
Sep 20, 2005
Last Update Posted:
Apr 29, 2010
Last Verified:
Apr 1, 2010
Additional relevant MeSH terms: