- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00203112
Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline
April 11, 2011 updated by: Teva Branded Pharmaceutical Products R&D, Inc.
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
Status
Completed
Conditions
Intervention / Treatment
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:
- 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.
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:
|
Experimental: Glatiramer Acetate with placebo
Glatiramer acetate injection 20mg with oral placebo
|
Subcutaneous injection glatiramer acetate 20mg, with oral placebo
Other Names:
|
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
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Adjuvants, Immunologic
- Glatiramer Acetate
- (T,G)-A-L
- Minocycline
Other Study ID Numbers
- GA 9014
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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