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

Phase 3

Completed

• Conditions: Restless Legs Syndrome
• Interventions: Drug: ASP8825

• Registration Number: NCT02658188
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-18
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ASP8825 group	ASP8825	-

Primary Outcome Measures

Name	Time	Method
Safety assessed by 12-lead-electrocardiogram	Up to Week 52
Change from baseline in IRLS score	Baseline to Week 52	IRLS: International Restless Legs Syndrome Scale
Safety assessed by Adverse Events	Up to Week 52
Safety assessed by Laboratory tests	Up to Week 52	Hematology, blood biochemistry, thyroid function test and urinalysis
Safety assessed by Vital signs	Up to Week 52	Blood pressure and pulse rate

Secondary Outcome Measures

Name	Time	Method
Change from baseline in SF-36v2	Baseline to Week 52	SF-36v2: Medical Outcomes Study 36-Item Short-Form Health Survey version 2
Change from baseline in MOS sleep scale	Baseline to Week 52	MOS: Medical outcomes study
Proportion of responders on ICGl of improvement	Up to Week 52	ICGI: Investigator-rated Clinical Global Impression of improvement
Proportion of responders on PCGI of improvement	Up to Week 52	PCGI: Patient-rated Clinical Global Impression
Change from baseline in PSQI	Baseline to Week 52	PSQI: Pittsburgh Sleep Quality Index
Change from baseline in RLS-QOL	Baseline to Week 52	RLS-QOL: Restless Legs Syndrome Quality of Life Questionnaire
Plasma concentration of gabapentin	Week 12, 28 and 52