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

Phase 3

Completed

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

• Registration Number: NCT00163046
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-13
• Study Start: 2005-10
• Study Completion: 2006-04
• Status Verified: 2008-04
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

• 18 years of age or older with occasional sleeplessness in the month prior to screening

Exclusion Criteria

• Current treatment for, or recent history (within 2 years) of, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition that interferes with the subject's sleep
• Currently taking or expected to take any of the following during trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbiturates, and phencyclidine during their participation in the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Gabapentin	Gabapentin	-

Primary Outcome Measures

Name	Time	Method
Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO)	Day 1

Secondary Outcome Measures

Name	Time	Method
PSG Sleep Efficiency (SE)	Days 1 and 28
Subjective WASO	Days 1 and 28
PSG Wake Time During Sleep (WTDS)	Days 1 and 28
Adverse events	Through Day 32
PSG Total Wake Time (TWT) plus Stage 1 Sleep	Days 1 and 28
PSG Percent of Stages 1, 2, 3, 4 and REM sleep	Days 1 and 28
PSG WAPSO	Day 28
PSG Percent Slow Wave Sleep (SWS, Stages 3&4 combined)	Days 1 and 28
Subjective SL	Days 1 and 28
Subjective ASQ	Days 1 and 28
Karolinska Sleep Diary (KSD)-Sleep Quality Index	Days 1 and 28
PSG Latency to Persistent Sleep (LPS)	Days 1 and 28
PSG Sleep Onset Latency (SOL)	Days 1 and 28
PSG Number of Awakenings (NAW)	Days 1 and 28
PSG Wake after Sleep Onset (WASO)	Days 1 and 28
PSG Total Sleep Time (TST)	Days 1 and 28
Subjective NA	Days 1 and 28
Subjective TST	Days 1 and 28
Subjective ASR	Days 1 and 28
Vital signs	Days 1 and 28
KSD individual scores	Days 1 and 28

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Overland Park, Kansas, United States