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Polysomnography Study of GSK1838262 (XP13512) Extended Release Tablets Versus Placebo in Restless Legs Syndrome (RLS) and Associated Sleep Disturbance
This study has been completed.
Study NCT00748098   Information provided by GlaxoSmithKline
First Received: September 5, 2008   Last Updated: November 19, 2009   History of Changes

September 5, 2008
November 19, 2009
October 2008
July 2009   (final data collection date for primary outcome measure)
Change from baseline to end of each treatment period in Wake Time During Sleep (WTDS) measured by polysomnography [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change from baseline to end of each treatment period in Wake Time During Sleep (WTDS) measured by polysomnography
Complete list of historical versions of study NCT00748098 on ClinicalTrials.gov Archive Site
  • Change from baseline to end of each treatment period in Periodic Limb Movements associated with Arousal per hour (PLMAI) measured by polysomnography [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes.
 
Polysomnography Study of GSK1838262 (XP13512) Extended Release Tablets Versus Placebo in Restless Legs Syndrome (RLS) and Associated Sleep Disturbance
Study RXP110908, a Polysomnography Study of GSK1838262 (XP13512) Extended Release Tablets Versus Placebo in the Treatment of Restless Legs Syndrome (RLS) and Associated Sleep Disturbance

The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study
Restless Legs Syndrome (RLS)
  • Drug: GSK1838262 Extended Release Tablets
  • Drug: Placebo
  • Other: GSK1838262 extended release tablets for Treatment Period 1 followed by Placebo for Treatment Period 2
  • Other: Placebo for Treatment Period 1 followed by GSK1838262 for Treatment Period 2
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
136
July 2009
July 2009   (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 15 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
  • Have history of RLS symptoms at least 15 nights/month.
  • Minimum average of 15 Periodic Limb Movements during Sleep per hour (measured using actigraphy).

Exclusion criteria:

  • Secondary RLS
  • Primary sleep disorder
  • Sleep apnea
  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00748098
Study Director, GSK
RXP110908
GlaxoSmithKline
 
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2009

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