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Trial record 3 of 4 for:
Minocycline multiple sclerosis
Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline
This study has been completed.
Sponsor:
Teva Pharmaceutical Industries
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00203112
First received: September 13, 2005
Last updated: April 11, 2011
Last verified: April 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Relapse Remitting Multiple Sclerosis | Drug: glatiramer acetate with minocycline Drug: Glatiramer acetate with placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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). |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by Teva Pharmaceutical Industries:
Primary Outcome Measures:
- 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:
- Assessment of tolerability and safety [ Time Frame: 24 months ]
| Enrollment: | 44 |
| Study Start Date: | June 2004 |
| Study Completion Date: | July 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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®
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00203112
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203112
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
| Study Director: | Jean Godin, MD | Teva Neuroscience Canada |
More Information
Additional Information:
Publications:
| Responsible Party: | Jean-Louis Strill, MD, Teva Canada Innovation |
| ClinicalTrials.gov Identifier: | NCT00203112 History of Changes |
| Other Study ID Numbers: |
GA 9014 |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 11, 2011 |
Additional relevant MeSH terms:
|
Sclerosis Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting 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 Anti-Bacterial Agents Anti-Infective Agents Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on September 19, 2017