CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 158 enrolled
Drug / intervention
Estriol +2 moredrug
Likely dose
Estriol 8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00451204
NCT00451204Phase 2Completed
CompareCT.gov

A Combination Trial of Copaxone Plus Estriol in RRMS

University of California, Los Angeles·interventional·Posted Mar 23, 2007·Updated Jun 16, 2016

In Brief

A Phase 2 clinical trial evaluating Estriol, Placebo, and 1 other intervention for Relapsing Remitting Multiple Sclerosis. Completed, enrolled 158 participants across 16 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Remitting Multiple Sclerosis
CountriesCanada, United States
CollaboratorsWashington University School of Medicine, University of Texas Southwestern Medical Center, Ohio State University, University of Medicine and Dentistry of New Jersey, University of Chicago, University of Utah, Johns Hopkins University, University of Kansas Medical Center, University of Minnesota, Mayo Clinic, University of Colorado, Denver, University of New Mexico, University of Pennsylvania, Dartmouth-Hitchcock Medical Center, National Multiple Sclerosis Society, National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 23, 2007
Enrollment StartMar 1, 2007
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 19.3 years ago

Interventions

Estrioldrug

Estriol 8 mg capsule, once per day, duration of treatment is 2 years

Placebodrug

Placebo capsule, once a day, treatment duration is 2 years

Copaxonedrug

Injection, once a day, all subjects