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.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00203086
First received: September 13, 2005
Last updated: April 27, 2010
Last verified: April 2010
  Purpose

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)
  Eligibility

Ages Eligible for Study:   20 Years to 57 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00203086

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

Additional Information:
No publications provided

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
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
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014