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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

1991-10-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Keywords

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multiple sclerosis neurologic and psychiatric disorders rare disease

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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copolymer 1

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Kenneth P. Johnson

Role: STUDY_CHAIR

University of Maryland

Other Identifiers

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UMB-55901

Identifier Type: -

Identifier Source: secondary_id

199/12023