Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline

Phase 2

Completed

• Conditions: Relapse Remitting Multiple Sclerosis
• Interventions: Drug: glatiramer acetate with minocycline; Drug: Glatiramer acetate with placebo

• Registration Number: NCT00203112
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2006-06
• Study Completion: 2006-07
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-11
• Last Update Posted: 2011-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glatiramer Acetate injection with oral minocycline	glatiramer acetate with minocycline	Glatiramer Acetate 20mg with oral minocycline 100mg
Glatiramer Acetate with placebo	Glatiramer acetate with placebo	Glatiramer acetate injection 20mg with oral placebo

Primary Outcome Measures

Name	Time	Method
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.	24 months

Secondary Outcome Measures

Name	Time	Method
Assessment of tolerability and safety	24 months