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

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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

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 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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U.S. FDA Resources





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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:


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
Study Director: Lillian Pardo, MD Teva Neuroscience, Inc.

Additional Information:
Responsible Party: Siyu Liu, Vice President, North American Innovative Research & Development and Head, Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00203086     History of Changes
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:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Glatiramer Acetate
Mitoxantrone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action