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

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

This study has been completed.
Information provided by Office of Rare Diseases (ORD)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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.

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 Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Multiple Sclerosis

Intervention ^†

Drug: copolymer 1

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

250

Start Date ^†

October 1991

Completion Date

Eligibility 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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00004814

Organization ID

199/12023

Secondary IDs ^††

UMB-55901

Study Sponsor ^†

National Center for Research Resources (NCRR)

Collaborators ^††

University of Maryland

Investigators ^†

Study Chair:

Kenneth P. Johnson

University of Maryland

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

January 1997

First Received Date ^†

February 24, 2000

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.