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NCT00203086 Clinical Trial

A Study to Evaluate the Long Term Safety and Effectiveness of Novantrone Therapy Followed by Copaxone Treatment for Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00203086
Other study ID # PM025
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated April 27, 2010
Start date October 2005
Est. completion date December 2009

Study information
Verified date April 2010
Source Teva Pharmaceutical Industries
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Therapeutics Products Directorate
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 57 Years
Eligibility Inclusion Criteria:

- Participation & completion of the NC-100 Clinical Trial.

- Able and willing to sign an Informed Consent.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Teva Pharmaceutical Industries
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