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

NCT03053427 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2024-12-12

Study results available
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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)

Interventions

DRUG

Placebo

Oral administration

DRUG

Gabapentin enacarbil

Oral administration

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-30
Primary Completion
2018-06-25
Completion
2018-06-25
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03053427 on ClinicalTrials.gov