A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose
A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy, Tolerability and Safety of 40 mg of Copaxone in the Treatment of Relapsing-Remitting Multiple Sclerosis Patients
What it found
We found no results in the registry or in papers.
This trial finished 21 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Glatiramer acetate
Unknown
What it measured
Main measures
The total number of T1 Gd-enhancing lesions in T1-weighted images, as measured at months 7, 8 and 9
MRI lesions
Who could take part
Relapsing MS · 18 to 50 · EDSS 0 to 5
Show the full criteria
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Aug 2003
Main results due
Sept 2005
Finished
Sept 2005