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

NCT ID: NCT03053427

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-30
• Study Completion Date: 2018-06-25

Brief 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.

Conditions

Restless Legs Syndrome (RLS)

Keywords

Restless Legs Syndrome; ASP8825; Gabapentin enacarbil

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo was administered orally once daily after the evening meal.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral administration

Gabapentin enacarbil

Gabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to \< 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week followed by gabapentin enacarbil 600 mg for 11 weeks.

Group Type: EXPERIMENTAL

Gabapentin enacarbil

Intervention Type: DRUG

Oral administration

Interventions

Placebo

Oral administration

Intervention Type: DRUG

Gabapentin enacarbil

Oral administration

Intervention Type: DRUG

Other Intervention Names

Regnite

Eligibility Criteria

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:

• Agree not to try to become pregnant during the study and for 28 days after the final study drug administration
• And have a negative urine pregnancy test at Screening
• And, if heterosexually active, agree to consistently use two forms of highly effective birth control starting at Screening and throughout the study period and for 28 days after the final study drug administration.

• Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
• Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
• Subject agrees not to participate in another interventional study while on treatment.
• Subject with a Body Mass Index of ≥ 18.5 and < 30.
• Subject with estimated creatinine clearance of ≥ 60 mL/min.

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.
• Subject has a history of hypersensitivity reaction to gabapentin.
• Subject has previously taken pregabalin, gabapentin enacarbil, or the study drug of Gabapentin enacarbil.
• Subject has participated in a clinical study for another investigational drug or medical device or post-marketing clinical study within 12 weeks (84 days) prior to the first dosing, or is currently participating in any of these studies.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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

Site JP00005

Kobe, Hyōgo, Japan

Site JP00038

Kawasaki, Kanagawa, Japan

Site JP00007

Yokohama, Kanagawa, Japan

Site JP00017

Yokohama, Kanagawa, Japan

Site JP00049

Yokohama, Kanagawa, Japan

Site JP00050

Yokohama, Kanagawa, Japan

Site JP00009

Yokosuka, Kanagawa, Japan

Site JP00032

Sakai, Osaka, Japan

Site JP00043

Tokorozawa, Saitama, Japan

Site JP00012

Arakawa City, Tokyo, Japan

Site JP00001

Chōfu, Tokyo, Japan

Site JP00028

Chōfu, Tokyo, Japan

Site JP00018

Chūō, Tokyo, Japan

Site JP00024

Chūō, Tokyo, Japan

Site JP00048

Meguro City, Tokyo, Japan

Site JP00034

Musashino, Tokyo, Japan

Site JP00046

Nakano City, Tokyo, Japan

Site JP00019

Ōta-ku, Tokyo, Japan

Site JP00011

Shibuya City, Tokyo, Japan

Site JP00013

Shinagawa, Tokyo, Japan

Site JP00015

Shinagawa, Tokyo, Japan

Site JP00016

Shinagawa, Tokyo, Japan

Site JP00008

Shinjuku, Tokyo, Japan

Site JP00014

Shinjuku, Tokyo, Japan

Site JP00021

Shinjuku, Tokyo, Japan

Site JP00031

Chiba, , Japan

Site JP00036

Fukuoka, , Japan

Site JP00020

Kyoto, , Japan

Site JP00035

Kyoto, , Japan

Site JP00010

Osaka, , Japan

Site JP00026

Osaka, , Japan

Site JP00037

Osaka, , Japan

Site JP00039

Osaka, , Japan

Site JP00047

Osaka, , Japan

Site JP00030

Saitama, , Japan

Site JP00044

Saitama, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=333

Link to results on the Astellas Clinical Study Results website

Other Identifiers

8825-CL-0101

Identifier Type: -

Identifier Source: org_study_id