A Study to Evaluate the Long Term Safety and Effectiveness of Novantrone Therapy Followed by Copaxone Treatment for Multiple Sclerosis
April 27, 2010 updated by: Teva Branded Pharmaceutical Products R&D, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
30
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 57 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Neurology Clinics
Description
Inclusion Criteria:
- Participation & completion of the NC-100 Clinical Trial.
- Able and willing to sign an Informed Consent.
Exclusion Criteria:
none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Lillian Pardo, MD, Teva Neuroscience, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
April 29, 2010
Last Update Submitted That Met QC Criteria
April 27, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PM025
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.