Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Relapse Remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: glatiramer acetate with minocycline
* Drug: Glatiramer acetate with placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically definite MS as defined by Poser et al. (Ann. Neurol. 1983) with disease duration (from onset) of at least 6 months. Subjects must have a relapsing-remitting disease course. Subjects must have had at least 1 documented relapse within the last year prior to study entry. Subjects must have at least 1 and not more than 15 gadolinium (Gd)-enhancing lesions on the screening MRI scan. Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit. Subjects may be male or female. Women of child- bearing potential must use a contraceptive method deemed reliable by the investigator. Subjects must be between the ages of 18 and 50 years inclusive. Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5.0 inclusive. Subjects must be willing and able to give written informed consent prior to entering the study. Exclusion Criteria: Previous use of injectable glatiramer acetate. Previous use of cladribine. Previous use of immunosuppressive agents in the last 6 months. Use of experimental or investigational drugs, including I.V. immunoglobulin and statins, within 6 months prior to study entry. Use of interferon agents or minocycline within 4 months prior to the screening visit. Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry. Previous total body irradiation or total lymphoid irradiation (TLI). Pregnancy or breast feeding. Subjects who experience a relapse between the screening (month -1) and baseline (month 0) visits. 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). A known history of sensitivity to mannitol. Contraindication to or known history of sensitivity to tetracyclines. A known history of sensitivity to gadolinium. Inability to successfully undergo MRI scanning.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glatiramer Acetate injection with oral minocycline<br>Glatiramer Acetate 20mg with oral minocycline 100mg | Drug: glatiramer acetate with minocycline<br>* Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg<br>* Other names: Copaxone®;|
| Experimental: Glatiramer Acetate with placebo<br>Glatiramer acetate injection 20mg with oral placebo | Drug: Glatiramer acetate with placebo<br>* Subcutaneous injection glatiramer acetate 20mg, with oral placebo<br>* Other names: Copaxone®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of tolerability and safety |  | 24 months |