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COMPLETED Phase 2

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

NCT00451204 · View on ClinicalTrials.gov ↗

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.

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00451204

The ClinicalTrials.gov registry entry for NCT00451204 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 829 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00451204 reports 16 study locations spanning 16 distinct geographic areas — top geographies include Arizona, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00451204?

The interventions under investigation include: Placebo (DRUG), Estriol (DRUG), Copaxone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00451204?

This trial is sponsored by University of California, Los Angeles, which has 829 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial