Relapse-Remitting Multiple Sclerosis
Conditions
Brief summary
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.
Interventions
glatiramer acetate 20 mg
DRUGglatiramer acetate 40 mg
glatiramer acetate 40 mg
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Clinically definite MS with disease duration (from onset) of at least 6 months. 2. Subjects must have had at least 1 documented relapse within the last year prior to study entry. 3. Subjects must have at least 1 and not more than 15 gadolinium (Gd)-enhancing lesions on the screening MRI scan. 4. Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit. 5. Subjects must not have taken corticosteroids (IV, IM and/or PO) between the screening and baseline visits. 6. 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). 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 inclusive. 9. Subjects must be willing and able to give written informed consent prior to entering the study.
Exclusion criteria
1. Previous use of glatiramer acetate (oral or injectable). 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/or participation in an investigational drug study within 6 months prior to study entry. 5. Use of interferon agents within 60 days 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. Patients who experience a relapse between the screening (month -1) and baseline (month 0) visits. 10. Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse. 11. A known history of sensitivity to mannitol. 12. A known sensitivity to gadolinium. 13. Inability to successfully undergo MRI scanning.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total number of T1 Gd-enhancing lesions in T1-weighted images, as measured at months 7, 8 and 9 | — |
Countries
United States
Outcome results
None listed