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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004814
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
University of Maryland, College Park
Information provided by:
Office of Rare Diseases (ORD)

Brief Summary:


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.

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

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

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 identifier (NCT number): NCT00004814

Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Maryland, College Park
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Study Chair: Kenneth P. Johnson University of Maryland, College Park
Layout table for additonal information Identifier: NCT00004814    
Other Study ID Numbers: 199/12023
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
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents