Last updated: 11/07/2018 08:33:14
A meta-analysis of three studies to evaluate key efficacy outcomes in subjects with moderate-to-severe Restless Legs Syndrome treated with Gabapentin Enacarbil at doses ranging from 600 mg/day to 2400 mg/day
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: A meta-analysis of three studies to evaluate key efficacy outcomes in subjects with moderate-to-severe Restless Legs Syndrome treated with Gabapentin Enacarbil at doses ranging from 600 mg/day to 2400 mg/day
Trial description: The objective of this meta-analysis is to provide supportive evidence of the efficacy of a 600mg dose (the lowest dose evaluated) of GEn in the 12-week placebo controlled studies using the International Restless Legs Scale (IRLS) and the investigator-rated Clinical Global Impression-Improvement (CGI-I) scale, drawing comparisons between GEn and placebo where applicable.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
investigator-rated Clinical Global Impression-Improvement (CGI-I) scale
Timeframe: 12 weeks
International Restless Legs Scale (IRLS)
Timeframe: 12 weeks
Secondary outcomes:
Not applicable
Interventions:
Drug: placebo
Drug: Gabapentin enacarbil 600mg, 1200mg, 1800mg, or 2400mg
Enrollment:
1
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
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)
September 2010 to September 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- All subjects who were randomized into studies XP052, XP053 and XP081
- none
Inclusion and exclusion criteria
Inclusion criteria:
- All subjects who were randomized into studies XP052, XP053 and XP081
Exclusion criteria:
- none
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
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2010-30-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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