Last updated: 11/07/2018 03:24:52
Long-Term Study of 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 Long-Term Study of XP13512 Versus Placebo Treatment Assessing Maintenance of Efficacy and Safety in Patients With Restless Legs Syndrome.
Trial description: The primary objective of this trial is to assess the maintenance of efficacy of gabapentin enacarbil (GEn, XP13512) taken once daily in the long-term treatment of patients suffering from Restless Legs Syndrome (RLS).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
The proportion of RLS patients relapsing during the double-blind treatment period.
Timeframe: 36 weeks
Secondary outcomes:
Change in the IRLS score at the end of treatment.
Timeframe: 36 weeks
Investigator and Patient Clinical Global Impression (CGI) of Improvement at the end of treatment.
Timeframe: 36 weeks
Subjective measures of sleep and quality of life.
Timeframe: 36 weeks
Interventions:
Drug: Placebo
Drug: GEn (XP13512)
Enrollment:
327
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Bogan RK, Bornemann MA, Kushida CA, Trân PV, Barrett RW; XP060 Study Group. Long-Term Maintenance Treatment of Restless Legs Syndrome with Gabapentin Enacarbil: A Randomized Controlled Study. Mayo Clin Proc. 2010;85(6):512-21.
Medical condition
Restless Legs Syndrome
Product
gabapentin enacarbil
Collaborators
Not applicable
Study date(s)
April 2006 to November 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 Group 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 Group 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
2007-14-11
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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