| 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
|
| |
| |
| 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 |