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

This study has been completed.
Information provided by:
Teva Pharmaceutical Industries Identifier:
First received: September 13, 2005
Last updated: April 27, 2010
Last verified: April 2010
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 Phase
Relapsing Remitting Multiple Sclerosis
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Teva Pharmaceutical Industries:

Enrollment: 30
Study Start Date: October 2005
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   20 Years to 57 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neurology Clinics

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00203086

Sponsors and Collaborators
Teva Pharmaceutical Industries
Study Director: Lillian Pardo, MD Teva Neuroscience, Inc.
  More Information

Additional Information:
Responsible Party: Siyu Liu, Vice President, North American Innovative Research & Development and Head, Teva Neuroscience Identifier: NCT00203086     History of Changes
Other Study ID Numbers: PM025 
Study First Received: September 13, 2005
Last Updated: April 27, 2010
Health Authority: United States: Food and Drug Administration
Canada: Therapeutics Products Directorate

Additional relevant MeSH terms:
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
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents
Antirheumatic Agents processed this record on October 25, 2016