Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline

• ClinicalTrials.gov Identifier: NCT00203112
• Recruitment Status: Completed
• First Posted: September 20, 2005
• Last Update Posted: April 12, 2011
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Information provided by: Teva Branded Pharmaceutical Products R&D, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Relapse Remitting Multiple Sclerosis	Drug: glatiramer acetate with minocycline; Drug: Glatiramer acetate with placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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).
• Study Start Date: June 2004
• Actual Primary Completion Date: June 2006
• Actual Study Completion Date: July 2006

Arms and Interventions

Arm	Intervention/treatment
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®

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Assessment of tolerability and safety [ Time Frame: 24 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• 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

Sponsors and Collaborators

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

• Study Director: Jean Godin, MD; Teva Neuroscience Canada

More Information

Publications of Results:

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.

• Responsible Party: Jean-Louis Strill, MD, Teva Canada Innovation
• ClinicalTrials.gov Identifier: NCT00203112
• Other Study ID Numbers: GA 9014
• First Posted: September 20, 2005
• Last Update Posted: April 12, 2011
• Last Verified: April 2011

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Minocycline; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Glatiramer Acetate; (T,G)-A-L; Anti-Bacterial Agents; Anti-Infective Agents; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Immunosuppressive Agents; Antirheumatic Agents