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Completed

NCT Number: NCT00666939

A Study of Single-Dose Gabapentin in Subjects With 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, using subjective sleep measurements, in subjects with transient insomnia induced by a sleep phase advance.

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Key information

Conditions

Transient Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

Gabapentin 100 mg oral capsule 30 minutes prior to bedtime

Placebo

Drug

Matched placebo 30 minutes prior to bedtime

Primary outcomes

  1. Subjective sleep latency

    Time frame: Hour +8

Secondary outcomes

  1. Stanford Sleepiness Scale

    Time frame: Hour +13

  2. Vital signs

    Time frame: Hour +8

  3. Adverse events

    Time frame: Hour +13

  4. Subjective number of awakenings

    Time frame: Hour +8

  5. Subjective wake after sleep onset

    Time frame: Hour +8

  6. Subjective total sleep time

    Time frame: Hour +8

  7. Subjective assessment of sleep refreshment

    Time frame: Hour +8

  8. Subjective assessment of sleep quality

    Time frame: Hour +8

  9. Karolinska Sleep Diary-Sleep (KSD) Quality Index

    Time frame: Hour +8

  10. KSD individual scores

    Time frame: Hour +8

  11. Digit Symbol Substitution Test

    Time frame: Hour +8

  12. Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)

    Time frame: Hour +8

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter Study Of Gabapentin 100 mg and 250 mg in Transient Insomnia Induced By A Sleep Phase Advance

Important dates

Study start
2004
Study completion
2005
First posted
Apr 25, 2008
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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