Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451204
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2007-03-22
Brief Title:
A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis RRMS
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
A Combination Trial of Copaxone Plus Estriol in RRMS
Status:
COMPLETED
Status Verified Date:
2016-05
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:
Estriol-MS
Brief Summary:
This is a double-blinded placebo controlled study of estriol pills versus placebo pills in relapsing remitting multiple sclerosis The study treatment will be an added on to Copaxone injections in all subjects The primary outcome measure is a reduction in relapses
Detailed Description:
Multiple sclerosis MS relapses are known to be significantly decreased during pregnancy This proposal will establish whether oral treatment with estriol the major estrogen of pregnancy induces a decrease in relapses in relapsing remitting multiple sclerosis RRMS subjects when used in combination with injectable Copaxone Previously in a pilot study it has been demonstrated that treatment of RRMS subjects with oral estriol for six months resulted in a significant reduction in gadolinium enhancing lesions on serial brain MRIs Annals of Neurology 2002 52421-428 and caused a favorable shift in immune responses Journal of Immunology 2003 1716267-6274 This is an add-on study aiming to extend these previous findings by treating longer and focusing on clinical outcomes The combination of Copaxone injection plus estriol pill 8 mg per day will be compared to Copaxone injection plus placebo pill in a double blind trial The duration of treatment will be two years and the primary outcome measure will be relapse rate Other outcomes will include disability measures and brain MRI outcomes Safety measures blood tests and gynecologic evaluations will also be followed and correlations will be made between serum estriol levels with efficacy and safety The overall goal of this study will be the development of a new oral treatment estriol for RRMS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RG3915 | OTHER_GRANT | NMSS | httpsreporternihgovquickSearchR01NS051591 |
| R01NS051591 | NIH | None | None |