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12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome ((CR-RLS))

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00373542
First Posted: September 8, 2006
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
September 7, 2006
September 8, 2006
October 12, 2017
October 2006
June 2007   (Final data collection date for primary outcome measure)
Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 12 Change from baseline in sleep Latency at Week 12. [ Time Frame: 12 Weeks ]
  • Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 8
  • Change from baseline in Wake Time During Sleep (WTDS) at Week 8.
Complete list of historical versions of study NCT00373542 on ClinicalTrials.gov Archive Site
Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes. [ Time Frame: 12 Weeks ]
Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes.
Not Provided
Not Provided
 
12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome
A 12-Week, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (RLS) in RLS Patients With Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Restless Legs Syndrome (RLS)
  • Restless Legs Syndrome
Drug: ropinirole CR-RLS
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
June 2007
June 2007   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • provided written informed consent.
  • Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
  • Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM.
  • Sleep efficiency <85% OR Latency to persistent sleep >20 minutes.

Exclusion criteria:

  • Secondary RLS
  • Primary sleep disorder
  • Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
  • Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
  • Use of any prohibited medication.
Sexes Eligible for Study: All
18 Years to 79 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00373542
RRL103660
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP