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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-04-30

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.

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Detailed Description

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Conditions

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Restless Legs Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASP8825 group

Group Type EXPERIMENTAL

ASP8825

Intervention Type DRUG

Oral

Interventions

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ASP8825

Oral

Intervention Type DRUG

Other Intervention Names

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gabapentin enacarbil

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No