The objective of this study was to assess the efficacy of once-daily oral administration of gabapentin enacarbil versus placebo, based on the change in International Restless Legs Syndrome Rating Scale (IRLS) score in participants with moderate-to-severe idiopathic restless legs syndrome. This study also assessed the safety of Gabapentin enacarbil.
After 1 week run in period with single-blind placebo, participants meeting the inclusion and none of the exclusion criteria were randomized to receive double-blind treatment with either gabapentin enacarbil 600 mg or placebo for 12 weeks treatment period. After then, single-blind placebo was given for 1 week for follow-up observation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
375
Oral administration
Oral administration
Change From Baseline in International Restless Legs Syndrome Rating Scale (IRLS) Score at Week 12
The IRLS consisted of 10-item scale for assessing severity of restless legs syndrome (RLS) with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 to 40. Higher IRLS score indicated greater disease activity. Mixed Model of Repeated Measurements (MMRM) model with compound symmetry as a covariance structure was used. The explanatory variables of the model included treatment group, IRLS score at baseline, age category, estimated creatinine clearance category, time point, and interaction of treatment group and time point.
Time frame: Baseline and week 12
Change From Baseline in IRLS Score at Each Time Point
ANCOVA model with the baseline value as a covariate was used.
Time frame: Baseline and weeks 1, 2, 4, 6, 8, 10, 12 and EoT (week 12)
Percentage of Participants With an Investigator-rated Clinical Global Impression (ICGI) Response
ICGI was assessed by 7-point ordinate scale. Participants who were "Very much improved" or "Much improved" were defined as responders.
Time frame: EoT (week 12)
Percentage of Participants With a Patient-rated Clinical Global Impression (PCGI) Response
PCGI was assessed by 7-point ordinate scale. Participants who were "Very much improved" or "Much improved" were defined as responders.
Time frame: EoT (week 12)
Change From Baseline in Pittsburgh Sleep Quality Index Total Score (PSQI)
The self-rated items of the PSQI generate seven component scores (range of subscale scores, 0-3). The sum of these seven component scores yielded one global score of subjective sleep quality (range, 0-21). Higher scores represent poorer subjective sleep. ANCOVA model with the baseline value as a covariate was used.
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Site JP00025
Nagoya, Aichi-ken, Japan
Site JP00029
Nagoya, Aichi-ken, Japan
Site JP00040
Nagoya, Aichi-ken, Japan
Site JP00006
Kitakyushu, Fukuoka, Japan
Site JP00022
Kitakyushu, Fukuoka, Japan
Site JP00002
Sapporo, Hokkaido, Japan
Site JP00003
Sapporo, Hokkaido, Japan
Site JP00004
Sapporo, Hokkaido, Japan
Site JP00023
Sapporo, Hokkaido, Japan
Site JP00041
Kawanishi, Hyōgo, Japan
...and 36 more locations
Time frame: Baseline and EoT (week 12)
Change From Baseline in Athens Insomnia Scale
Athens Insomnia Scale consisted of 8-item scale (range of subscale scores, 0-3). The scale range of Athens Insomnia was 0-24. Higher scores represent poorer sleep quality. ANCOVA model with the baseline value as a covariate was used.
Time frame: Baseline and EoT (week 12)
Change From Baseline in Restless Legs Syndrome (RLS) Pain Score
The scale range of RLS pain score was 0-10. Higher scores represent greater RLS pain intensity. ANCOVA model with the baseline value as a covariate was used.
Time frame: Baseline and EoT (week 12)
Change From Baseline in Health Status Score of EuroQol-5 Dimension-5 Level (EQ-5D-5L)
Health status was assessed by general visual analog scale (VAS). The VAS ranges from 0 (worst health status) and 100 (best health status).
Time frame: Baseline and EoT (week 12)
Number of Participants With Adverse Events
Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) with onset after the start of the run-in period. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. Serious TEAE was an AE considered serious.
Time frame: From first dose of study drug up to week 13