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NCT00451204 · ClinicalTrials.gov registry record · Phase 2

A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS)

A Phase 2 study of Relapsing Remitting Multiple Sclerosis, sponsored by University of California, Los Angeles.

Completed
Registry status
Phase 2
Development phase
158
Enrollment target
16
Study locations

NCT00451204: Completed Phase 2 study of Relapsing Remitting Multiple Sclerosis, sponsored by University of California, Los Angeles.

NCT00451204 is a Phase 2 study of Relapsing Remitting Multiple Sclerosis that has completed, run by University of California, Los Angeles. The registered enrollment target is 158 participants, below the 196-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (19% lower). The trial reports 16 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00451204, a Phase 2 study of Relapsing Remitting Multiple Sclerosis, has completed, sponsored by University of California, Los Angeles.

COMPLETED
Registry status
Phase 2
Development phase
158 participants
Enrollment target
16
Study locations

Study 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.

Primary Outcome

A confirmed relapse was defined as new neurological symptoms or worsening of pre-existing symptoms, lasting at least 48 hours in a subject who had been neurologically stable or improving in the previous 30 days, accompanied by objective change in the neurological examination (worsening of 0.5 points on the EDSS or worsening by 1.0 or more points on the pyramidal, cerebellar, brainstem or visual functional system scores), not due to fatigue alone and not associated with fever or infection.

Conditions Studied

Relapsing Remitting Multiple Sclerosis

Interventions

  • DRUG Placebo
  • DRUG Estriol
  • DRUG Copaxone

Study Locations (16)

Arizona

  • Mayo Clinic - Scottsdale

California

  • University of California, Los Angeles - Los Angeles

Colorado

  • University of Colorado - Aurora

Illinois

  • University of Chicago - Chicago

Kansas

  • University of Kansas - Kansas City

Maryland

  • Johns Hopkins University - Baltimore

Minnesota

  • University of Minnesota - Minneapolis

Missouri

  • Washington University - St Louis

Trial Details

FieldValue
Enrollment Target 158 participants
Start Date 2007-03
Est. Completion 2014-07
Phase Phase 2
University of California, Los Angeles

897 total trials

What the finished NCT00451204 record still lists

NCT00451204 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 196-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (19% lower).

The record links to 1 condition, with Relapsing Remitting Multiple Sclerosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00451204 lists 16 locations in 16 states (Arizona, California, Colorado).

Frequently Asked Questions

What is clinical trial NCT00451204 about?

NCT00451204 is a clinical study titled "A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS)". 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.

What is the current status of trial NCT00451204?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 158 participants. The study started on 2007-03. Estimated completion is 2014-07.

What conditions does trial NCT00451204 study?

This clinical trial studies the following conditions: Relapsing Remitting Multiple Sclerosis.

What interventions are being tested in trial NCT00451204?

The interventions under investigation include: Placebo (DRUG), Estriol (DRUG), Copaxone (DRUG).

Who is sponsoring clinical trial NCT00451204?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00451204 being conducted?

This trial has 16 study locations across Arizona, California, Colorado, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Relapsing Remitting Multiple Sclerosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00451204's enrollment target sits among peer trials

158 8th of 25 higher than 18 of 25 other Relapsing Remitting Multiple Sclerosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Relapsing Remitting Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00451204, the US trial registry maintained by the National Library of Medicine. NCT00451204 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.