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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP8825 group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP8825 | Drug | Oral |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in IRLS score | IRLS: International Restless Legs Syndrome Scale | Baseline to Week 52 |
| Safety assessed by Vital signs | Blood pressure and pulse rate | Up to Week 52 |
| Safety assessed by Adverse Events | Up to Week 52 | |
| Safety assessed by Laboratory tests | Hematology, blood biochemistry, thyroid function test and urinalysis | Up to Week 52 |
| Safety assessed by 12-lead-electrocardiogram | Up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responders on ICGl of improvement | ICGI: Investigator-rated Clinical Global Impression of improvement | Up to Week 52 |
| Proportion of responders on PCGI of improvement | PCGI: Patient-rated Clinical Global Impression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiba | Japan | |||||
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| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results Web site | View source |
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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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| Up to Week 52 |
| Change from baseline in PSQI | PSQI: Pittsburgh Sleep Quality Index | Baseline to Week 52 |
| Change from baseline in SF-36v2 | SF-36v2: Medical Outcomes Study 36-Item Short-Form Health Survey version 2 | Baseline to Week 52 |
| Change from baseline in RLS-QOL | RLS-QOL: Restless Legs Syndrome Quality of Life Questionnaire | Baseline to Week 52 |
| Change from baseline in MOS sleep scale | MOS: Medical outcomes study | Baseline to Week 52 |
| Plasma concentration of gabapentin | Week 12, 28 and 52 |
| Fukuoka |
| Japan |
| Hokkaido | Japan |
| Hyōgo | Japan |
| Kanagawa | Japan |
| Kyoto | Japan |
| Miyagi | Japan |
| Osaka | Japan |
| Saitama | Japan |
| Tokyo | Japan |
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |