Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline

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).

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glatiramer Acetate injection with oral minocycline
Glatiramer Acetate 20mg with oral minocycline 100mg
Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg
Other Names:
  • Copaxone®
Experimental: Glatiramer Acetate with placebo
Glatiramer acetate injection 20mg with oral placebo
Subcutaneous injection glatiramer acetate 20mg, with oral placebo
Other Names:
  • Copaxone®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of tolerability and safety
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

April 12, 2011

Last Update Submitted That Met QC Criteria

April 11, 2011

Last Verified

April 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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