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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00203086
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 29, 2010
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Study Description
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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
Relapsing Remitting Multiple Sclerosis

Study Design
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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 : October 2005
Actual Primary Completion Date : October 2009
Actual Study Completion Date : December 2009

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   20 Years to 57 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neurology Clinics
Criteria

Inclusion Criteria:

  • Participation & completion of the NC-100 Clinical Trial.
  • Able and willing to sign an Informed Consent.

Exclusion Criteria:

none

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203086


Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
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Study Director: Lillian Pardo, MD Teva Neuroscience, Inc.
More Information
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Responsible Party: Siyu Liu, Vice President, North American Innovative Research & Development and Head, Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00203086    
Other Study ID Numbers: PM025
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 29, 2010
Last Verified: April 2010
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases