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

This study has been completed.
Sponsor:
Collaborator:
University of Maryland
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004814
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: January 1997
  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 3

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

Resource links provided by NLM:


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
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 April 16, 2014