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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 28-day, Polysomnographic Study of Gabapentin 250 mg in Transient Insomnia Induced by a Sleep Phase Advance

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.

Study Overview

• Status: Completed
• Conditions: Transient Insomnia
• Intervention / Treatment: Drug: Gabapentin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Pfizer Investigational Site
    • San Diego, California, United States, 92123
      • Pfizer Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matched placebo 30 minutes prior to bedtime for 28 days
Experimental: Gabapentin	Drug: Gabapentin; Gabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO)	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
PSG WAPSO	Day 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 Wake Time (TWT) plus Stage 1 Sleep	Days 1 and 28
PSG Wake Time During Sleep (WTDS)	Days 1 and 28
PSG Total Sleep Time (TST)	Days 1 and 28
PSG Sleep Efficiency (SE)	Days 1 and 28
PSG Percent of Stages 1, 2, 3, 4 and REM sleep	Days 1 and 28
PSG Percent Slow Wave Sleep (SWS, Stages 3&4 combined)	Days 1 and 28
Subjective SL	Days 1 and 28
Subjective NA	Days 1 and 28
Subjective WASO	Days 1 and 28
Subjective TST	Days 1 and 28
Subjective ASR	Days 1 and 28
Subjective ASQ	Days 1 and 28
Karolinska Sleep Diary (KSD)-Sleep Quality Index	Days 1 and 28
KSD individual scores	Days 1 and 28
Vital signs	Days 1 and 28
Adverse events	Through Day 32

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 13, 2005

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: A9451155