Last updated: 11/07/2018 18:14:20
Polysomnography study of GSK1838262 (XP13512) extended release tablets versus placebo in Restless Legs Syndrome (RLS) and associated sleep disturbance
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from baseline to end of each treatment period in Wake Time During Sleep (WTDS) measured by polysomnography
Timeframe: 4 weeks
Secondary outcomes:
Change from baseline to end of each treatment period in Periodic Limb Movements associated with Arousal per hour (PLMAI) measured by polysomnography
Timeframe: 4 weeks
Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes.
Timeframe: 4 weeks
Interventions:
Drug: Placebo
Drug: GSK1838262 Extended Release Tablets
Enrollment:
136
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
J. Winkelman, R. Bogan, M. Schmidt, J. Hudson, S. DeRossett, C. Hill-Zabala. A randomized, placebo-controlled polysomnography study of gabapentin enacarbil in subjects with RLS. [Mov Disord]. 2011;26(11):2065-2072.
M Calloway; M Bharmal; C Hill-Zabala; R Allen. Development and Validation of a Subjective Post Sleep Diary to Assess Sleep Status in Subjects with Restless Legs Syndrome . [Sleep Med]. 2011;DOI 10.1016(/j.sleep.):2010.09.020.
Medical condition
Restless Legs Syndrome
Product
gabapentin enacarbil
Collaborators
Not applicable
Study date(s)
October 2008 to July 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- 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.
- Secondary RLS
- Primary sleep disorder
Inclusion and exclusion criteria
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.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-22-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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