drugset / Trial / NCT00163046

A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

NCT00163046 ↗

Phase 3 Completed 256 enrolled Viatris Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with transient insomnia induced by a sleep phase advance.

Timeline

Start
2005-10
Primary completion
—
Completion
2006-04

Outcome

Met primary endpoint

paper Gabapentin resulted in significantly less PSG wake after sleep onset (WASO) compared with placebo on Day 1 (primary endpoint, mean: 107.0 versus 149.1 min PMID 25317091 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Gabapentin Unknown 250 mg Oral

Indications