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

NCT03053427 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 8825-CL-0101
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 46

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.

Conditions

Restless Legs Syndrome (RLS)

Keywords

Restless Legs Syndrome; ASP8825; Gabapentin enacarbil

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in International Restless Legs Syndrome Rating Scale (IRLS) Score at Week 12

  The IRLS consisted of 10-item scale for assessing severity of restless legs syndrome (RLS) with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 to 40. Higher IRLS score indicated greater disease activity. Mixed Model of Repeated Measurements (MMRM) model with compound symmetry as a covariance structure was used. The explanatory variables of the model included treatment group, IRLS score at baseline, age category, estimated creatinine clearance category, time point, and interaction of treatment group and time point.

  Baseline and week 12

Secondary Outcomes (8)

• Change From Baseline in IRLS Score at Each Time Point

  Baseline and weeks 1, 2, 4, 6, 8, 10, 12 and EoT (week 12)

• Percentage of Participants With an Investigator-rated Clinical Global Impression (ICGI) Response

  EoT (week 12)

• Percentage of Participants With a Patient-rated Clinical Global Impression (PCGI) Response

  EoT (week 12)

• Change From Baseline in Pittsburgh Sleep Quality Index Total Score (PSQI)

  Baseline and EoT (week 12)

• Change From Baseline in Athens Insomnia Scale

  Baseline and EoT (week 12)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo was administered orally once daily after the evening meal.

Drug: Placebo

Gabapentin enacarbil

EXPERIMENTAL

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.

Drug: Gabapentin enacarbil

Interventions

Placebo DRUG

Oral administration

Placebo

Gabapentin enacarbil DRUG

Oral administration

Also known as: Regnite

Gabapentin enacarbil

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (46)

Site JP00025

Nagoya, Aichi-ken, Japan

Location

Site JP00029

Nagoya, Aichi-ken, Japan

Location

Site JP00040

Nagoya, Aichi-ken, Japan

Location

Site JP00006

Kitakyushu, Fukuoka, Japan

Location

Site JP00022

Kitakyushu, Fukuoka, Japan

Location

Site JP00002

Sapporo, Hokkaido, Japan

Location

Site JP00003

Sapporo, Hokkaido, Japan

Location

Site JP00004

Sapporo, Hokkaido, Japan

Location

Site JP00023

Sapporo, Hokkaido, Japan

Location

Site JP00041

Kawanishi, Hyōgo, Japan

Location

Site JP00005

Kobe, Hyōgo, Japan

Location

Site JP00038

Kawasaki, Kanagawa, Japan

Location

Site JP00007

Yokohama, Kanagawa, Japan

Location

Site JP00017

Yokohama, Kanagawa, Japan

Location

Site JP00049

Yokohama, Kanagawa, Japan

Location

Site JP00050

Yokohama, Kanagawa, Japan

Location

Site JP00009

Yokosuka, Kanagawa, Japan

Location

Site JP00032

Sakai, Osaka, Japan

Location

Site JP00043

Tokorozawa, Saitama, Japan

Location

Site JP00012

Arakawa City, Tokyo, Japan

Location

Site JP00001

Chōfu, Tokyo, Japan

Location

Site JP00028

Chōfu, Tokyo, Japan

Location

Site JP00018

Chūō, Tokyo, Japan

Location

Site JP00024

Chūō, Tokyo, Japan

Location

Site JP00048

Meguro City, Tokyo, Japan

Location

Site JP00034

Musashino, Tokyo, Japan

Location

Site JP00046

Nakano City, Tokyo, Japan

Location

Site JP00019

Ōta-ku, Tokyo, Japan

Location

Site JP00011

Shibuya City, Tokyo, Japan

Location

Site JP00013

Shinagawa, Tokyo, Japan

Location

Site JP00015

Shinagawa, Tokyo, Japan

Location

Site JP00016

Shinagawa, Tokyo, Japan

Location

Site JP00008

Shinjuku, Tokyo, Japan

Location

Site JP00014

Shinjuku, Tokyo, Japan

Location

Site JP00021

Shinjuku, Tokyo, Japan

Location

Site JP00031

Chiba, Japan

Location

Site JP00036

Fukuoka, Japan

Location

Site JP00020

Kyoto, Japan

Location

Site JP00035

Kyoto, Japan

Location

Site JP00010

Osaka, Japan

Location

Site JP00026

Osaka, Japan

Location

Site JP00037

Osaka, Japan

Location

Site JP00039

Osaka, Japan

Location

Site JP00047

Osaka, Japan

Location

Site JP00030

Saitama, Japan

Location

Site JP00044

Saitama, Japan

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Results Point of Contact

• Title: Clinical Trial Disclosure
• Organization: Astellas Pharma Inc.

astellas.resultsdisclosure@astellas.com

+81 3-3244-0512

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2017
• First Posted: February 15, 2017
• Study Start: March 30, 2017
• Primary Completion: June 25, 2018
• Study Completion: June 25, 2018
• Last Updated: December 12, 2024
• Results First Posted: July 10, 2019

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (46)