NCT03053427

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	Placebo	Oral administration
DRUG	Gabapentin enacarbil	Oral administration

Timeline

• Start date: 2017-03-30
• Primary completion: 2018-06-25
• Completion: 2018-06-25
• First posted: 2017-02-15
• Last updated: 2024-12-12
• Results posted: 2019-07-10

Locations

46 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study