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Trial record 3 of 4 for:    Minocycline multiple sclerosis
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Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline

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ClinicalTrials.gov Identifier: NCT00203112
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 12, 2011
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Study Description
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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.

Condition or disease Intervention/treatment Phase
Relapse Remitting Multiple Sclerosis Drug: glatiramer acetate with minocycline Drug: Glatiramer acetate with placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
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).
Study Start Date : June 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : July 2006

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Arms and Interventions
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Arm Intervention/treatment
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®


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Assessment of tolerability and safety [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203112


Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Director: Jean Godin, MD Teva Neuroscience Canada
More Information
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Additional Information:
For more information on Multiple Sclerosis  This link exits the ClinicalTrials.gov site

Publications of Results:

Responsible Party: Jean-Louis Strill, MD, Teva Canada Innovation
ClinicalTrials.gov Identifier: NCT00203112     History of Changes
Other Study ID Numbers: GA 9014
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 12, 2011
Last Verified: April 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