The objective of this study is to evaluate the efficacy and safety of ASP8825 (gabapentin enacarbil) for long-term treatment of restless legs syndrome patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Oral
Unnamed facility
Chiba, Japan
Unnamed facility
Fukuoka, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Hyōgo, Japan
Change from baseline in IRLS score
IRLS: International Restless Legs Syndrome Scale
Time frame: Baseline to Week 52
Safety assessed by Vital signs
Blood pressure and pulse rate
Time frame: Up to Week 52
Safety assessed by Adverse Events
Time frame: Up to Week 52
Safety assessed by Laboratory tests
Hematology, blood biochemistry, thyroid function test and urinalysis
Time frame: Up to Week 52
Safety assessed by 12-lead-electrocardiogram
Time frame: Up to Week 52
Proportion of responders on ICGl of improvement
ICGI: Investigator-rated Clinical Global Impression of improvement
Time frame: Up to Week 52
Proportion of responders on PCGI of improvement
PCGI: Patient-rated Clinical Global Impression
Time frame: Up to Week 52
Change from baseline in PSQI
PSQI: Pittsburgh Sleep Quality Index
Time frame: Baseline to Week 52
Change from baseline in SF-36v2
SF-36v2: Medical Outcomes Study 36-Item Short-Form Health Survey version 2
Time frame: Baseline to Week 52
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Unnamed facility
Kanagawa, Japan
Unnamed facility
Kyoto, Japan
Unnamed facility
Miyagi, Japan
Unnamed facility
Osaka, Japan
Unnamed facility
Saitama, Japan
Unnamed facility
Tokyo, Japan
Change from baseline in RLS-QOL
RLS-QOL: Restless Legs Syndrome Quality of Life Questionnaire
Time frame: Baseline to Week 52
Change from baseline in MOS sleep scale
MOS: Medical outcomes study
Time frame: Baseline to Week 52
Plasma concentration of gabapentin
Time frame: Week 12, 28 and 52