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

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.

Timeline

Start

2017-03-30

Primary completion

2018-06-25

Completion

2018-06-25

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Gabapentin Enacarbil; p = 0.088; LSM difference -1.2 (95% CI -2.6 to 0.2) NCT03053427 ↗

Drugs

Indications