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

Primary Purpose

Relapse-Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
glatiramer acetate 20 mg
glatiramer acetate 40 mg
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapse-Remitting Multiple Sclerosis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Center for Neurologic Study
  • North County Neurology Associates
  • The MS Center of Atlanta
  • Consultants in Neurology, Ltd
  • Indiana University School of Medicine
  • The Maryland Center for M.S.
  • Michigan Institute of Neurological Disorders
  • The Minneapolis Clinic of Neurology, LTD
  • University of Minnesota
  • St. John's Mercy Medical Center
  • Clinical & Magnetic Resonance Research Ctr.
  • MSSM - Corinne Goldsmith Dickinson Center for MS
  • University of Rochester
  • Cleveland Clinic Foundation
  • Geisinger Medical Center
  • Allegheny Neurological Associates
  • University of Tennessee
  • VAMC
  • MS Hub Medical Group
  • Neurology & Neurosurgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

glatiramer acetate 20 mg

glatiramer acetate 40 mg

Arm Description

glatiramer acetate 20 mg

glatiramer acetate 40 mg

Outcomes

Primary Outcome Measures

The total number of T1 Gd-enhancing lesions in T1-weighted images, as measured at months 7, 8 and 9

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
January 12, 2010
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00202982
Brief Title
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

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapse-Remitting Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
glatiramer acetate 20 mg
Arm Type
Active Comparator
Arm Description
glatiramer acetate 20 mg
Arm Title
glatiramer acetate 40 mg
Arm Type
Active Comparator
Arm Description
glatiramer acetate 40 mg
Intervention Type
Drug
Intervention Name(s)
glatiramer acetate 20 mg
Intervention Description
glatiramer acetate 20 mg
Intervention Type
Drug
Intervention Name(s)
glatiramer acetate 40 mg
Intervention Description
glatiramer acetate 40 mg
Primary Outcome Measure Information:
Title
The total number of T1 Gd-enhancing lesions in T1-weighted images, as measured at months 7, 8 and 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffery Cohen, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Center for Neurologic Study
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
North County Neurology Associates
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
The MS Center of Atlanta
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Consultants in Neurology, Ltd
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
The Maryland Center for M.S.
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Michigan Institute of Neurological Disorders
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
The Minneapolis Clinic of Neurology, LTD
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
St. John's Mercy Medical Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Clinical & Magnetic Resonance Research Ctr.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
MSSM - Corinne Goldsmith Dickinson Center for MS
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Allegheny Neurological Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
VAMC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
MS Hub Medical Group
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Neurology & Neurosurgery
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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