Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

Study Overview
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Brief Summary
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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.

Official Title
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Long-term Study - Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

Conditions
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Restless Legs Syndrome

Intervention / Treatment
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* Drug: ASP8825


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who diagnosed with RLS according to the diagnostic criteria established by the International RLS Study Group International Restless Legs Syndrome Scale (IRLS) score ≥15 presence of RLS symptoms on ≥15 days per month and ≥4 days per week preceding inclusion in this study Exclusion Criteria: Patients using dopamine agonists or gabapentin within 1 week before or any anti-RLS treatment within 2 weeks before the start of the pretreatment observation period Patients with an estimated creatinine clearance <60 mL/min determined using the Cockcroft-Gault formula Pregnant or lactating women Individuals with serum ferritin <20 ng/mL were also excluded from the trial Individuals with movement disorders and/or abnormal neurological findings

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP8825 group<br> | Drug: ASP8825<br>* Oral<br>* Other names: gabapentin enacarbil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Restless legs syndrome patients, ASP8825, XP13512