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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Copolymer 1 for Relapsing-Remitting Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00004814
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
University of Maryland, College Park
Information provided by:
Office of Rare Diseases (ORD)

Study Description
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Brief Summary:

OBJECTIVES:

I. Compare tolerance to and therapeutic impact of copolymer 1, a mixture of synthetic polypeptides, with placebo in patients with relapsing-remitting multiple sclerosis.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: copolymer 1 Phase 3

Detailed Description:

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.

One group receives copolymer 1, a mixture of synthetic polypeptides composed of 4 amino acids, subcutaneously each day for 2 years.

The other group receives an injection of placebo daily for 2 years.


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : October 1991

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Clinically or laboratory-supported definite multiple sclerosis
  • Neurologically stable for at least 30 days prior to entry Expanded Disability Status Scale score no greater than 5
  • At least 2 documented relapses within 2 years prior to entry Onset of first relapse at least 1 year prior to randomization

--Prior/Concurrent Therapy--

  • Biologic therapy: No prior copolymer 1
  • Immunosuppressive therapy: No prior cytotoxic immunosuppressives, i.e.: Azathioprine Cyclophosphamide Cyclosporine At least 30 days since corticosteroids
  • Radiotherapy: No prior lymphoid irradiation

--Patient Characteristics--

  • Not HIV or HTLV-I seropositive No insulin-dependent diabetes mellitus No Lyme disease No requirement for aspirin or chronic nonsteroidal anti-inflammatory drugs No pregnant or nursing women Adequate contraception required of fertile women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004814


Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Maryland, College Park
Investigators
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Study Chair: Kenneth P. Johnson University of Maryland, College Park
More Information
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ClinicalTrials.gov Identifier: NCT00004814     History of Changes
Other Study ID Numbers: 199/12023
UMB-55901
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 1997
Keywords provided by Office of Rare Diseases (ORD):
multiple sclerosis
neurologic and psychiatric disorders
rare disease
Additional relevant MeSH terms:
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Glatiramer Acetate
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
(T,G)-A-L
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents