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

A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study of Gabapentin 250 mg and 500 mg in Transient Insomnia Induced by a Sleep Phase Advance

The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 309
• 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, 66211
      • Pfizer Investigational Site
    • Overland Park, Kansas, United States, 66212
      • Pfizer Investigational Site
  • New York
    • New York, New York, United States, 10025
      • 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:

• 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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matched placebo 30 minutes prior to bedtime
Experimental: Gabapentin 250 mg	Drug: Gabapentin; Gabapentin 250 mg oral capsule 30 minutes prior to bedtime; Drug: Gabapentin; Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
Experimental: Gabapentin 500 mg	Drug: Gabapentin; Gabapentin 250 mg oral capsule 30 minutes prior to bedtime; Drug: Gabapentin; Gabapentin 500 mg oral capsule 30 minutes prior to bedtime

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Latency to persistent sleep as measured by polysomnography	Hour +8

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Study Completion (Actual): November 1, 2004

Study Registration Dates

• First Submitted: April 23, 2008
• First Submitted That Met QC Criteria: April 23, 2008
• First Posted (Estimate): April 25, 2008

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: A9451139