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NCT00373542 · ClinicalTrials.gov registry record · Phase 4

12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome

A Phase 4 study of Restless Legs Syndrome and Restless Legs Syndrome (RLS), sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 4
Development phase
39
Enrollment target
20
Study locations

NCT00373542 is a Phase 4 study of Restless Legs Syndrome and Restless Legs Syndrome (RLS) that has completed, run by GlaxoSmithKline. The registered enrollment target is 39 participants, below the 94-participant average among 14 other Restless Legs Syndrome trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT00373542, a Phase 4 study of Restless Legs Syndrome and Restless Legs Syndrome (RLS), has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 4
Development phase
39 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.

Interventions

  • DRUG ropinirole CR-RLS

Study Locations (20)

Florida

  • GSK Investigational Site - Brandon
  • GSK Investigational Site - Pembroke Pines
  • GSK Investigational Site - St. Petersburg

Georgia

  • GSK Investigational Site - Atlanta
  • GSK Investigational Site - Austell
  • GSK Investigational Site - Macon

Alabama

  • GSK Investigational Site - Jasper
  • GSK Investigational Site - Tuscaloosa

California

  • GSK Investigational Site - Anaheim
  • GSK Investigational Site - San Diego

Colorado

  • GSK Investigational Site - Greenwood
  • GSK Investigational Site - Wheat Ridge

Illinois

  • GSK Investigational Site - Elk Grove Village
  • GSK Investigational Site - Normal

Kansas

  • GSK Investigational Site - Lenexa
  • GSK Investigational Site - Topeka

Arizona

  • GSK Investigational Site - Phoenix

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2006-10
Est. Completion 2007-06
Phase Phase 4

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT00373542

The ClinicalTrials.gov registry entry for NCT00373542 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 94-participant average among 14 other Restless Legs Syndrome trials with a reported enrollment target (59% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Restless Legs Syndrome appearing as the primary indexed condition, and to 1 intervention - of which ropinirole CR-RLS is the first listed.

NCT00373542 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, Georgia, Alabama.

Frequently Asked Questions

What is clinical trial NCT00373542 about?

NCT00373542 is a clinical study titled "12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome". The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.

What is the current status of trial NCT00373542?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 39 participants. The study started on 2006-10. Estimated completion is 2007-06.

What conditions does trial NCT00373542 study?

This clinical trial studies the following conditions: Restless Legs Syndrome, Restless Legs Syndrome (RLS).

What interventions are being tested in trial NCT00373542?

The interventions under investigation include: ropinirole CR-RLS (DRUG).

Who is sponsoring clinical trial NCT00373542?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00373542 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.

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

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