Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline

NCT00203112 | Completed Phase 2 DMC

• 1 other identifier: GA 9014
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Relapse Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (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.

  24 months

Secondary Outcomes (1)

• Assessment of tolerability and safety

  24 months

Study Arms (2)

Glatiramer Acetate injection with oral minocycline

ACTIVE COMPARATOR

Glatiramer Acetate 20mg with oral minocycline 100mg

Drug: glatiramer acetate with minocycline

Glatiramer Acetate with placebo

EXPERIMENTAL

Glatiramer acetate injection 20mg with oral placebo

Drug: Glatiramer acetate with placebo

Interventions

glatiramer acetate with minocycline DRUG

Subcutaneous injection glatiramer acetate 20mg, with oral minocycline 100mg

Also known as: Copaxone®

Glatiramer Acetate injection with oral minocycline

Glatiramer acetate with placebo DRUG

Subcutaneous injection glatiramer acetate 20mg, with oral placebo

Also known as: Copaxone®

Glatiramer Acetate with placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Related 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, multicenter, double-blind, placebo-controlled trial. Mult Scler. 2009 Oct;15(10):1183-94. doi: 10.1177/1352458509106779. Epub 2009 Sep 23.

  PMID: 19776092 RESULT

MeSH Terms

Interventions

Glatiramer Acetate; Minocycline

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Jean Godin, MD

  Teva Neuroscience Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2004
• Primary Completion: June 1, 2006
• Study Completion: July 1, 2006
• Last Updated: April 12, 2011

Record last verified: 2011-04