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

Primary Purpose

Transient Insomnia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transient Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gabapentin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO)

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2005
Last Updated
February 1, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00163046
Brief Title
A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 28-day, Polysomnographic Study of Gabapentin 250 mg in Transient Insomnia Induced by a Sleep Phase Advance
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo 30 minutes prior to bedtime for 28 days
Primary Outcome Measure Information:
Title
Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
PSG WAPSO
Time Frame
Day 28
Title
PSG Latency to Persistent Sleep (LPS)
Time Frame
Days 1 and 28
Title
PSG Sleep Onset Latency (SOL)
Time Frame
Days 1 and 28
Title
PSG Number of Awakenings (NAW)
Time Frame
Days 1 and 28
Title
PSG Wake after Sleep Onset (WASO)
Time Frame
Days 1 and 28
Title
PSG Total Wake Time (TWT) plus Stage 1 Sleep
Time Frame
Days 1 and 28
Title
PSG Wake Time During Sleep (WTDS)
Time Frame
Days 1 and 28
Title
PSG Total Sleep Time (TST)
Time Frame
Days 1 and 28
Title
PSG Sleep Efficiency (SE)
Time Frame
Days 1 and 28
Title
PSG Percent of Stages 1, 2, 3, 4 and REM sleep
Time Frame
Days 1 and 28
Title
PSG Percent Slow Wave Sleep (SWS, Stages 3&4 combined)
Time Frame
Days 1 and 28
Title
Subjective SL
Time Frame
Days 1 and 28
Title
Subjective NA
Time Frame
Days 1 and 28
Title
Subjective WASO
Time Frame
Days 1 and 28
Title
Subjective TST
Time Frame
Days 1 and 28
Title
Subjective ASR
Time Frame
Days 1 and 28
Title
Subjective ASQ
Time Frame
Days 1 and 28
Title
Karolinska Sleep Diary (KSD)-Sleep Quality Index
Time Frame
Days 1 and 28
Title
KSD individual scores
Time Frame
Days 1 and 28
Title
Vital signs
Time Frame
Days 1 and 28
Title
Adverse events
Time Frame
Through Day 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25317091
Citation
Furey SA, Hull SG, Leibowitz MT, Jayawardena S, Roth T. A randomized, double-blind, placebo-controlled, multicenter, 28-day, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. J Clin Sleep Med. 2014 Oct 15;10(10):1101-9. doi: 10.5664/jcsm.4110.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9451155&StudyName=A%2028-Day%20Polysomnographic%20Study%20of%20Gabapentin%20in%20Transient%20Insomnia%20Induced%20by%20a%20Sleep%20Phase%20Advance
Description
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A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

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