Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline

Relapse Remitting Multiple Sclerosis Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203112
• Other study ID #: GA 9014
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: April 11, 2011
• Start date: June 2004
• Est. completion date: July 2006

Study information

• Verified date: April 2011
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapse Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• glatiramer acetate with minocycline
Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg
• Glatiramer acetate with placebo
Subcutaneous injection glatiramer acetate 20mg, with oral placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

References & Publications (1)

Metz LM, Li D, Traboulsee A, Myles ML, Duquette P, Godin J, Constantin M, Yong VW; GA/minocycline study investigators. Glatiramer acetate in combination with minocycline in patients with relapsing--remitting multiple sclerosis: results of a Canadian, mult — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24 months	No
Secondary	Assessment of tolerability and safety		24 months	Yes

External Links

•   For more information on Multiple Sclerosis