Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00203112
First received: September 13, 2005
Last updated: April 11, 2011
Last verified: April 2011
  Purpose

This study investigates the add-on effect of oral minocycline in subjects treated with daily injection of Copaxone. Copaxone and minocycline are thought to have differential modes of actions that may complement each other in treating MS symptoms.


Condition Intervention Phase
Relapse Remitting Multiple Sclerosis
Drug: glatiramer acetate with minocycline
Drug: Glatiramer acetate with placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Centered, Randomized, Double-Blind, Placebo-Controlled, Parallel Study Assessing the Add-on Effect of Minocycline in Relapsing-Remitting Multiple Sclerosis (RR-MS) Subjects Treated With Glatiramer Acetate (GA).

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • To evaluate the add-on treatment effect of oral minocycline in subjects treated with daily injection of GA as reflected by number of MRI T1 Gd-enhancing lesions in T1-weighted images. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of tolerability and safety [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: June 2004
Study Completion Date: July 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glatiramer Acetate injection with oral minocycline
Glatiramer Acetate 20mg with oral minocycline 100mg
Drug: glatiramer acetate with minocycline
Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg
Other Name: Copaxone®
Experimental: Glatiramer Acetate with placebo
Glatiramer acetate injection 20mg with oral placebo
Drug: Glatiramer acetate with placebo
Subcutaneous injection glatiramer acetate 20mg, with oral placebo
Other Name: Copaxone®

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinically definite MS as defined by Poser et al. (Ann. Neurol. 1983) with disease duration (from onset) of at least 6 months.
  2. Subjects must have a relapsing-remitting disease course.
  3. Subjects must have had at least 1 documented relapse within the last year prior to study entry.
  4. Subjects must have at least 1 and not more than 15 gadolinium (Gd)-enhancing lesions on the screening MRI scan.
  5. Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit.
  6. Subjects may be male or female. Women of child- bearing potential must use a contraceptive method deemed reliable by the investigator.
  7. Subjects must be between the ages of 18 and 50 years inclusive.
  8. Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5.0 inclusive.
  9. Subjects must be willing and able to give written informed consent prior to entering the study.

Exclusion Criteria:

  1. Previous use of injectable glatiramer acetate.
  2. Previous use of cladribine.
  3. Previous use of immunosuppressive agents in the last 6 months.
  4. Use of experimental or investigational drugs, including I.V. immunoglobulin and statins, within 6 months prior to study entry.
  5. Use of interferon agents or minocycline within 4 months prior to the screening visit.
  6. Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry.
  7. Previous total body irradiation or total lymphoid irradiation (TLI).
  8. Pregnancy or breast feeding.
  9. Subjects who experience a relapse between the screening (month -1) and baseline (month 0) visits.
  10. Significant medical or psychiatric condition that affects the subject's ability to give informed consent, or to complete the study, or any condition which the investigator feels may interfere with participation in the study (e.g. alcohol or drug abuse).
  11. A known history of sensitivity to mannitol.
  12. Contraindication to or known history of sensitivity to tetracyclines.
  13. A known history of sensitivity to gadolinium.
  14. Inability to successfully undergo MRI scanning.
  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: NCT00203112

Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Director: Jean Godin, MD Teva Neuroscience Canada
  More Information

Publications:
Responsible Party: Jean-Louis Strill, MD, Teva Canada Innovation
ClinicalTrials.gov Identifier: NCT00203112     History of Changes
Other Study ID Numbers: GA 9014
Study First Received: September 13, 2005
Last Updated: April 11, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Copolymer 1
Minocycline
Adjuvants, Immunologic
Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2015