Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline
Information source: Teva Pharmaceutical Industries
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Relapse Remitting Multiple Sclerosis
Intervention: glatiramer acetate (Drug); minocycline (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Teva Pharmaceutical Industries Official(s) and/or principal investigator(s):
Jean Godin, MD, Study Director, Affiliation: Teva Neuroscience Canada
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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.
Locations and Contacts
Foothills Medical Centre, Calgary, Alberta T2N 2T9, Canada
Northern Alberta Clinical Trial Research Center, Edmonton, Alberta T6G 2C8, Canada
UBC Hospital MS Research, Vancouver, British Columbia V6T 2B5, Canada
CHUM - Hôpital Notre-Dame, Montreal, Quebec H2L 4M1, Canada
Additional Information
For more information on Multiple Sclerosis
Starting date: May 2004
Ending date: June 2006
Last updated: May 23, 2007
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