Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline

NCT ID: NCT00203112

Last Updated: 2011-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2006-07-31

Brief Summary

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.

Conditions

Relapse Remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Glatiramer Acetate injection with oral minocycline

Glatiramer Acetate 20mg with oral minocycline 100mg

Group Type: ACTIVE_COMPARATOR

glatiramer acetate with minocycline

Intervention Type: DRUG

Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg

Glatiramer Acetate with placebo

Glatiramer acetate injection 20mg with oral placebo

Group Type: EXPERIMENTAL

Glatiramer acetate with placebo

Intervention Type: DRUG

Subcutaneous injection glatiramer acetate 20mg, with oral placebo

Interventions

glatiramer acetate with minocycline

Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg

Intervention Type: DRUG

Glatiramer acetate with placebo

Subcutaneous injection glatiramer acetate 20mg, with oral placebo

Intervention Type: DRUG

Other Intervention Names

Copaxone®; Copaxone®

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Teva Canada Innovation

Principal Investigators

Jean Godin, MD

Role: STUDY_DIRECTOR

Teva Neuroscience Canada

References

Metz LM, Li D, Traboulsee A, Myles ML, Duquette P, Godin J, Constantin M, Yong VW; GA/minocycline study investigators. Glatiramer acetate in combination with minocycline in patients with relapsing--remitting multiple sclerosis: results of a Canadian, multicenter, double-blind, placebo-controlled trial. Mult Scler. 2009 Oct;15(10):1183-94. doi: 10.1177/1352458509106779. Epub 2009 Sep 23.

Reference Type: RESULT

PMID: 19776092 (View on PubMed)

Other Identifiers

GA 9014

Identifier Type: -

Identifier Source: org_study_id