Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004814
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Randomized Double-Blind Placebo-Controlled Study of Copolymer 1 for Relapsing-Remitting Multiple Sclerosis
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1997-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMB-55901 | None | None | None |