A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

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 on polysomnographic assessments in transient insomnia induced by a sleep phase advance.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 377
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • Pfizer Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Pfizer Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • 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 who reported occasional sleeplessness in the month prior to screening
• 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)
• Currently taking or expected to take any of the following during the trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbituates, and phencyclidine

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: C	Drug: Placebo; Matched placebo oral capsule 30 minutes prior to bedtime
Experimental: A	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: B	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
Wake after sleep onset as measured by polysomnography (PSG)	Hour +8

Secondary Outcome Measures

Outcome Measure	Time Frame
Vital signs	Hour +8
Adverse events	Hour +13
Karolinska Sleep Diary-Sleep (KSD) Quality Index	Hour +8
KSD individual scores	Hour +8
PSG Latency to Persistent Sleep	Hour +8
PSG Wake Time During Sleep	Hour +8
PSG WASO	Hour +8
PSG Sleep Onset Latency	Hour +8
PSG NA	Hour +8
PSG Total wake time plus Stage 1 sleep	Hour +8
PSG TST	Hour +8
PSG Sleep Efficiency	Hour +8
PSG Percent of Stages 1, 2, 3, 4 and REM sleep	Hour +8
PSG Percent slow wave sleep (Stages 3&4 combined)	Hour +8
subjective Sleep Latency	Hour +8
subjective Number of Awakenings (NA)	Hour +8
subjective Wake After Sleep Onset (WASO)	Hour +8
subjective Total Sleep Time (TST)	Hour +8
subjective Assessment of Sleep Refreshment	Hour +8
subjective Assessment of Sleep Quality	Hour +8

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Rosenberg RP, Hull SG, Lankford DA, Mayleben DW, Seiden DJ, Furey SA, Jayawardena S, Roth T. A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. J Clin Sleep Med. 2014 Oct 15;10(10):1093-100. doi: 10.5664/jcsm.4108.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Study Completion (Actual): August 1, 2006

Study Registration Dates

• First Submitted: May 6, 2008
• First Submitted That Met QC Criteria: May 7, 2008
• First Posted (Estimate): May 8, 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, 2011

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: A9451157