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Completed

NCT Number: NCT00163046

A 28-Day Polysomnographic Study of Gabapentin 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.

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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, Glendale, 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

  • 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

Treatment and study plan

Gabapentin

Drug

Gabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days

Placebo

Drug

Matched placebo 30 minutes prior to bedtime for 28 days

Primary outcomes

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

    Time frame: Day 1

Secondary outcomes

  1. PSG WAPSO

    Time frame: Day 28

  2. PSG Latency to Persistent Sleep (LPS)

    Time frame: Days 1 and 28

  3. PSG Sleep Onset Latency (SOL)

    Time frame: Days 1 and 28

  4. PSG Number of Awakenings (NAW)

    Time frame: Days 1 and 28

  5. PSG Wake after Sleep Onset (WASO)

    Time frame: Days 1 and 28

  6. PSG Total Wake Time (TWT) plus Stage 1 Sleep

    Time frame: Days 1 and 28

  7. PSG Wake Time During Sleep (WTDS)

    Time frame: Days 1 and 28

  8. PSG Total Sleep Time (TST)

    Time frame: Days 1 and 28

  9. PSG Sleep Efficiency (SE)

    Time frame: Days 1 and 28

  10. PSG Percent of Stages 1, 2, 3, 4 and REM sleep

    Time frame: Days 1 and 28

  11. PSG Percent Slow Wave Sleep (SWS, Stages 3&4 combined)

    Time frame: Days 1 and 28

  12. Subjective SL

    Time frame: Days 1 and 28

  13. Subjective NA

    Time frame: Days 1 and 28

  14. Subjective WASO

    Time frame: Days 1 and 28

  15. Subjective TST

    Time frame: Days 1 and 28

  16. Subjective ASR

    Time frame: Days 1 and 28

  17. Subjective ASQ

    Time frame: Days 1 and 28

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

    Time frame: Days 1 and 28

  19. KSD individual scores

    Time frame: Days 1 and 28

  20. Vital signs

    Time frame: Days 1 and 28

  21. Adverse events

    Time frame: Through Day 32

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

Important dates

Study start
2005
Study completion
2006
First posted
Sep 13, 2005
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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