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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Dose 1 |
|
| 2 | Experimental | Dose 2 |
|
| 3 | Experimental | Dose 3 |
|
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP8825 | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of the International Restless Legs Syndrome rating scale score | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-related Clinical Global Impression of Improvement | 12 weeks | |
| Patient- related Clinical Global Impression of Improvement | 12 weeks | |
| The Pittsburgh sleep quality index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23121149 | Derived | Inoue Y, Hirata K, Uchimura N, Kuroda K, Hattori N, Takeuchi M. Gabapentin enacarbil in Japanese patients with restless legs syndrome: a 12-week, randomized, double-blind, placebo-controlled, parallel-group study. Curr Med Res Opin. 2013 Jan;29(1):13-21. doi: 10.1185/03007995.2012.746217. Epub 2012 Nov 30. |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| C493250 | 1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid |
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| Placebo | Drug | oral |
|
| 12 weeks |
| The SF-36 Health Survey | 12 weeks |
| The Restless Legs Syndrome QOL Questionnaire | 12 weeks |
| The Medical Outcomes Study sleep scale | 12 weeks |
| Hokkaido |
| Japan |
| Kansai | Japan |
| Kanto | Japan |
| Kyusyu | Japan |
| TÅhoku | Japan |
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |