A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

Phase 3

Completed

• Conditions: Transient Insomnia
• Interventions: Drug: Placebo; Drug: Gabapentin

• Registration Number: NCT00674752
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in transient insomnia induced by a sleep phase advance.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study Completion: 2006-08
• Study First Submitted: 2008-05-06
• Study First Submitted QC: 2008-05-07
• Study First Posted: 2008-05-08
• Status Verified: 2011-04
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

Inclusion Criteria

• Aged >/= 18 years who reported occasional sleeplessness in the month prior to screening
• Females of child-bearing potential using medically-acceptable method of birth control >/= 1 month prior to screening

Exclusion Criteria

• Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition)
• Currently taking or expected to take any of the following during the trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbituates, and phencyclidine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	Placebo	-
A	Gabapentin	-
B	Gabapentin	-

Primary Outcome Measures

Name	Time	Method
Wake after sleep onset as measured by polysomnography (PSG)	Hour +8

Secondary Outcome Measures

Name	Time	Method
PSG Sleep Efficiency	Hour +8
Adverse events	Hour +13
PSG Wake Time During Sleep	Hour +8
PSG Sleep Onset Latency	Hour +8
PSG Latency to Persistent Sleep	Hour +8
PSG WASO	Hour +8
PSG Percent of Stages 1, 2, 3, 4 and REM sleep	Hour +8
subjective Wake After Sleep Onset (WASO)	Hour +8
subjective Assessment of Sleep Quality	Hour +8
Vital signs	Hour +8
PSG NA	Hour +8
subjective Assessment of Sleep Refreshment	Hour +8
Karolinska Sleep Diary-Sleep (KSD) Quality Index	Hour +8
PSG Total wake time plus Stage 1 sleep	Hour +8
subjective Sleep Latency	Hour +8
KSD individual scores	Hour +8
PSG TST	Hour +8
subjective Total Sleep Time (TST)	Hour +8
PSG Percent slow wave sleep (Stages 3&4 combined)	Hour +8
subjective Number of Awakenings (NA)	Hour +8

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Cincinnati, Ohio, United States