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A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE4

A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

Gabapentin Enacarbil Post-marketing Clinical Study A Randomized, Double-blind, Placebo-controlled, Parallel-group Study in Subjects With Restless Legs Syndrome.

NCT03053427•Astellas Pharma Inc

View on ClinicalTrials.gov

Summary

The objective of this study was to assess the efficacy of once-daily oral administration of gabapentin enacarbil versus placebo, based on the change in International Restless Legs Syndrome Rating Scale (IRLS) score in participants with moderate-to-severe idiopathic restless legs syndrome. This study also assessed the safety of Gabapentin enacarbil.

Detailed Description

After 1 week run in period with single-blind placebo, participants meeting the inclusion and none of the exclusion criteria were randomized to receive double-blind treatment with either gabapentin enacarbil 600 mg or placebo for 12 weeks treatment period. After then, single-blind placebo was given for 1 week for follow-up observation.

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject has Restless Legs Syndrome (RLS), based on the International Restless Legs Syndrome Study Group (IRLSSG) Diagnostic Criteria.
•Subject has reported history of RLS symptoms for at least 15 days in the month prior to the first dosing; if on treatment, this frequency of symptoms was started before treatment.
•Subject with International Restless Legs Syndrome Rating Scale (IRLS) score ≥ 15.
•Subject has discontinued dopamine agonists, and/or gabapentin at least 1 week prior to the first dosing.
•Subject has discontinued other treatments for RLS at least 2 weeks prior to the first dosing.
•Female subject must either:
•Be of non-childbearing potential:
•Post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
•documented surgically sterile
•Or, if of childbearing potential:
+8 more criteria

Exclusion Criteria

•Subject has a sleep disorder that may significantly affect the assessment of RLS.
•Subject has a history of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment.
•Subject has neurologic disease or movement disorder.
•Subject has poorly controlled diabetes, iron deficiency anemia, or are currently taking any sedative/hypnotic.
•Subject has a history of suicide attempt within 6 months prior to informed consent.
•Subject has a high level of Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST).
•Subject is currently suffering from moderate or severe depression.
•Subject has a history of alcohol dependence or drug abuse, or subject had alcohol or drug abuse or dependence in the last 1 year.
•Subject is a shift worker, professional driver, or operator of dangerous machinery.
•Subject has clinically significant or unstable medical conditions.
+3 more criteria

Locations (46)

Site JP00025

Nagoya, Aichi-ken, Japan

Site JP00029

Nagoya, Aichi-ken, Japan

Site JP00040

Nagoya, Aichi-ken, Japan

Site JP00006

Kitakyushu, Fukuoka, Japan

Site JP00022

Kitakyushu, Fukuoka, Japan

Site JP00002

Sapporo, Hokkaido, Japan

Site JP00003

Sapporo, Hokkaido, Japan

Site JP00004

Sapporo, Hokkaido, Japan

Site JP00023

Sapporo, Hokkaido, Japan

Site JP00041

Kawanishi, Hyōgo, Japan

Key Dates

Start Date

March 30, 2017

Primary Completion Date

June 25, 2018

Completion Date

June 25, 2018

Last Updated

December 12, 2024

Enrollment

375

ACTUAL participants

Conditions

Restless Legs Syndrome (RLS)

Interventions

Placebo

DRUG

Gabapentin enacarbil

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

Inclusion Criteria

Exclusion Criteria

12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome

Study to Assess the Effect of Gabapentin Enacarbil on Simulated Driving in Healthy Subjects

The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome