A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

Phase 3

Completed

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

• Registration Number: NCT00666770
• 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 as compared to placebo on sleep in subjects with transient insomnia.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study Completion: 2004-11
• Status Verified: 2008-04
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-25
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

Inclusion Criteria

• Aged >/= 18 years
• 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)
• Recreational drug use within past 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Gabapentin 250 mg	Gabapentin	-
Gabapentin 500 mg	Gabapentin	-

Primary Outcome Measures

Name	Time	Method
Latency to persistent sleep as measured by polysomnography	Hour +8

Secondary Outcome Measures

Name	Time	Method
Subjective total sleep time	Hour +8
Subjective assessment of sleep refreshment	Hour +8
Subjective assessment of sleep quality	Hour +8
Stanford Sleepiness Scale	Hour +13
Subjective wake after sleep onset	Hour +8
Karolinska Sleep Diary-Sleep (KSD) Quality Index	Hour +8
KSD individual scores	Hour +8
Number of awakenings	Hour +8
Vital signs	Hour +8
Subjective sleep latency	Hour +8
Digit Symbol Substitution Test	Hour +8
Latency to REM sleep	Hour +8
Sleep efficiency	Hour +8
Percent of Stages 1, 2, 3, 4 (non-REM) and REM sleep	Hour +8
Wake after sleep onset	Hour +8
Total wake time plus Stage 1 sleep	Hour +8
Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)	Hour +8
Adverse events	Hour +13
Percent slow wave sleep (Stages 3&4 combined)	Hour +8
Total sleep time	Hour +8
Sleep onset latency	Hour +8
Subjective number of awakenings	Hour +8

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New York, New York, United States