Clinical trial NCT00202982: A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved Dose
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapse-Remitting Multiple Sclerosis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The total number of T1 Gd-enhancing lesions in T1-weighted images, as measured at months 7, 8 and 9
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Center for Neurologic Study
state: California
city: Oceanside
country: United States
facility: North County Neurology Associates
state: California
city: Atlanta
country: United States
facility: The MS Center of Atlanta
state: Georgia
city: Northbrook
country: United States
facility: Consultants in Neurology, Ltd
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Baltimore
country: United States
facility: The Maryland Center for M.S.
state: Maryland
city: Farmington Hills
country: United States
facility: Michigan Institute of Neurological Disorders
state: Michigan
city: Golden Valley
country: United States
facility: The Minneapolis Clinic of Neurology, LTD
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: St. Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
city: Albuquerque
country: United States
facility: Clinical & Magnetic Resonance Research Ctr.
state: New Mexico
city: New York
country: United States
facility: MSSM - Corinne Goldsmith Dickinson Center for MS
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Neurological Associates
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: Salt Lake City
country: United States
facility: VAMC
state: Utah
city: Seattle
country: United States
facility: MS Hub Medical Group
state: Washington
city: Tacoma
country: United States
facility: Neurology & Neurosurgery
state: Washington
Study officials:
affiliation: The Cleveland Clinic
name: Jeffery Cohen, MD
role: STUDY_CHAIR
References: