To demonstrate the superiority of ASP8825 over placebo and the dose response in patients with restless legs syndrome
Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with restless legs syndrome
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
474
Unnamed facility
Chugoku, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kanto, Japan
Unnamed facility
Kyusyu, Japan
The change of the International Restless Legs Syndrome rating scale score
Time frame: 12 weeks
Investigator-related Clinical Global Impression of Improvement
Time frame: 12 weeks
Patient- related Clinical Global Impression of Improvement
Time frame: 12 weeks
The Pittsburgh sleep quality index
Time frame: 12 weeks
The SF-36 Health Survey
Time frame: 12 weeks
The Restless Legs Syndrome QOL Questionnaire
Time frame: 12 weeks
The Medical Outcomes Study sleep scale
Time frame: 12 weeks
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Unnamed facility
Tōhoku, Japan