Trials / Completed
CompletedNCT00004814
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Copolymer 1 for Relapsing-Remitting Multiple Sclerosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 250 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | copolymer 1 |
Timeline
- Start date
- 1991-10-01
- First posted
- 2000-02-25
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00004814. Inclusion in this directory is not an endorsement.