A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved Dose

Teva Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Relapse-Remitting Multiple Sclerosis

Treatments

Drug: glatiramer acetate 40 mg

Drug: glatiramer acetate 20 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00202982

9006

Details and patient eligibility

About

This is a study to test if a new higher dose of Copaxone is more effective in treating relapsing-remitting multiple sclerosis than the currently available 20 mg dose.

Enrollment

90 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinically definite MS with disease duration (from onset) of at least 6 months.
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 must not have taken corticosteroids (IV, IM and/or PO) between the screening and baseline visits.
Subjects may be male or female. Women of child- bearing potential must practice a medically acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, or double-barrier method (condom or IUD with spermicide).
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 inclusive.
Subjects must be willing and able to give written informed consent prior to entering the study.

Exclusion criteria

Previous use of glatiramer acetate (oral or injectable).
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/or participation in an investigational drug study within 6 months prior to study entry.
Use of interferon agents within 60 days 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.
Patients who experience a relapse between the screening (month -1) and baseline (month 0) visits.
Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse.
A known history of sensitivity to mannitol.
A known sensitivity to gadolinium.
Inability to successfully undergo MRI scanning.