Relapse-Remitting Multiple Sclerosis Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | September 2005 |
Est. primary completion date | September 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Clinical & Magnetic Resonance Research Ctr. | Albuquerque | New Mexico |
United States | The MS Center of Atlanta | Atlanta | Georgia |
United States | The Maryland Center for M.S. | Baltimore | Maryland |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Michigan Institute of Neurological Disorders | Farmington Hills | Michigan |
United States | The Minneapolis Clinic of Neurology, LTD | Golden Valley | Minnesota |
United States | Indiana University School of Medicine | Indianapolis | Indiana |
United States | Center for Neurologic Study | La Jolla | California |
United States | University of Tennessee | Memphis | Tennessee |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | MSSM - Corinne Goldsmith Dickinson Center for MS | New York | New York |
United States | Consultants in Neurology, Ltd | Northbrook | Illinois |
United States | North County Neurology Associates | Oceanside | California |
United States | Allegheny Neurological Associates | Pittsburgh | Pennsylvania |
United States | University of Rochester | Rochester | New York |
United States | VAMC | Salt Lake City | Utah |
United States | MS Hub Medical Group | Seattle | Washington |
United States | St. John's Mercy Medical Center | St. Louis | Missouri |
United States | Neurology & Neurosurgery | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
Teva Pharmaceutical Industries |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The total number of T1 Gd-enhancing lesions in T1-weighted images, as measured at months 7, 8 and 9 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01704183 -
Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis
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N/A |