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COMPLETED Phase 3

A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

NCT00363857 · View on ClinicalTrials.gov ↗

Study Summary

A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States.

Interventions

  • DRUG Ropinirole

Study Locations (20)

California

  • GSK Investigational Site — Berkeley
  • GSK Investigational Site — La Jolla
  • GSK Investigational Site — Northridge
  • GSK Investigational Site — Oxnard
  • GSK Investigational Site — Redondo Beach
  • GSK Investigational Site — Santa Monica
  • GSK Investigational Site — Stanford

Alabama

  • GSK Investigational Site — Alabaster
  • GSK Investigational Site — Birmingham
  • GSK Investigational Site — Jasper
  • GSK Investigational Site — Tuscaloosa

Florida

  • GSK Investigational Site — Boca Raton
  • GSK Investigational Site — Largo
  • GSK Investigational Site — Pembroke Pines
  • GSK Investigational Site — St. Petersburg

Arizona

  • GSK Investigational Site — Phoenix
  • GSK Investigational Site — Phoenix

Arkansas

  • GSK Investigational Site — Little Rock

Colorado

  • GSK Investigational Site — Aurora

Connecticut

  • GSK Investigational Site — Danbury

Trial Details

FieldValue
Enrollment Target 360 participants
Start Date 2003-08
Est. Completion 2004-05
Phase Phase 3

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00363857

The ClinicalTrials.gov registry entry for NCT00363857 describes a study currently listed as completed. It is categorized as Phase 3, 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 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Restless Legs Syndrome appearing as the primary indexed condition, and to 1 intervention — of which Ropinirole 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: NCT00363857 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Alabama, Florida. 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 NCT00363857 about?

NCT00363857 is a clinical study titled "A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome". A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States.

What is the current status of trial NCT00363857?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 360 participants. The study started on 2003-08. Estimated completion is 2004-05.

What conditions does trial NCT00363857 study?

This clinical trial studies the following conditions: Restless Legs Syndrome, Restless Legs Syndrome (RLS). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00363857?

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

Who is sponsoring clinical trial NCT00363857?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00363857 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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