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

This study has been completed.

First Received on February 24, 2000. Last Updated on June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	University of Maryland
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004814

Purpose

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	Intervention	Phase
Multiple Sclerosis	Drug: copolymer 1	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Copolymer 1

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	250
Study Start Date:	October 1991

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004814

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of Maryland

Investigators

Study Chair:

Kenneth P. Johnson

University of Maryland

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00004814 History of Changes
Other Study ID Numbers:	199/12023, UMB-55901
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

multiple sclerosis
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases

Immune System Diseases
Pathologic Processes
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 12, 2012