Last updated: 11/07/2018 03:24:40
XP13512 vs. Placebo in Patients With Restless Legs Syndrome.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome.
Trial description: The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
proportion of patients at the end of treatment who are
Timeframe: 12 Weeks
The change from baseline to the end of treatment in IRLS rating scale score
Timeframe: 12 WEEKS
Secondary outcomes:
Onset of efficacy
Timeframe: 12 Weeks
subjective measures of sleep
Timeframe: 12 Weeks
Interventions:
Drug: PLACEBO
Drug: XP13512 600MG
Drug: XP13512 1200MG
Enrollment:
325
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
D. Lee, R. Ziman, T. Perkins, S. Poceta, A. Walters, R. Barrett. A randomized, double-blind, placebo-controlled study to assess the efficacy and tolerability of gabapentin enacarbil in subjects with Restless Legs Syndrome. [J Clin Sleep Med]. 2011;7(3):282-92.
Daniel Canafax; Abhijeet Bhanegaonkar; Murtuza Bharmal; Michael Calloway. Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind, multicenter, placebo-controlled clinical trials. [BMC Neurology]. 2011;11(48):
R Bogan, A Ellenbogen, P Becker, C Kushida, E Ball, W Ondo, C Caivano, S Kavanagh. Gabapentin Enacarbil in Subjects with Moderate-to-Severe Primary Restless Legs Syndrome with and without Severe Sleep Disturbance: An Integrated Analysis of Subjective and Novel Sleep Endpoints from Two Studies. J Parkinsonism RLS. 2013;3:31-40.
Samantha Warren, Sarah Kavanagh, Susan VanMeter, Ron Barrett. Comparison of Multiple Doses of Gabapentin Enacarbil versus Placebo in Subjects with Moderate-to-Severe Primary Restless Legs Syndrome: An Integrated Analysis of Three 12-Week Studies. [CNS Drugs]. 2012;26(9):773-780.
Medical condition
Restless Legs Syndrome
Product
gabapentin enacarbil
Collaborators
Not applicable
Study date(s)
August 2006 to December 2007
Type
Interventional
Phase
2/3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Patients with primary RLS, based on the International RLS Study Diagnostic Criteria.
- A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS;
- Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease,
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with primary RLS, based on the International RLS Study Diagnostic Criteria.
Exclusion criteria:
- A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS;
- Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias, and dystonias);
- Abnormal laboratory results, electrocardiogram (ECG) or physical findings;
- Pregnant or lactating women;
- Women of childbearing potential who are not practicing an acceptable method of birth control.
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
2007-20-12
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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