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Completed

NCT Number: NCT00674752

A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in 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, Miami, Florida, 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 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

Treatment and study plan

Gabapentin

Drug

Gabapentin 250 mg oral capsule 30 minutes prior to bedtime

Placebo

Drug

Matched placebo oral capsule 30 minutes prior to bedtime

Primary outcomes

  1. Wake after sleep onset as measured by polysomnography (PSG)

    Time frame: Hour +8

Secondary outcomes

  1. PSG Latency to Persistent Sleep

    Time frame: Hour +8

  2. PSG Wake Time During Sleep

    Time frame: Hour +8

  3. PSG WASO

    Time frame: Hour +8

  4. PSG Sleep Onset Latency

    Time frame: Hour +8

  5. Vital signs

    Time frame: Hour +8

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

    Time frame: Hour +8

  7. KSD individual scores

    Time frame: Hour +8

  8. PSG NA

    Time frame: Hour +8

  9. Adverse events

    Time frame: Hour +13

  10. PSG Total wake time plus Stage 1 sleep

    Time frame: Hour +8

  11. PSG TST

    Time frame: Hour +8

  12. PSG Sleep Efficiency

    Time frame: Hour +8

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

    Time frame: Hour +8

  14. PSG Percent slow wave sleep (Stages 3&4 combined)

    Time frame: Hour +8

  15. subjective Sleep Latency

    Time frame: Hour +8

  16. subjective Number of Awakenings (NA)

    Time frame: Hour +8

  17. subjective Wake After Sleep Onset (WASO)

    Time frame: Hour +8

  18. subjective Total Sleep Time (TST)

    Time frame: Hour +8

  19. subjective Assessment of Sleep Refreshment

    Time frame: Hour +8

  20. subjective Assessment of Sleep Quality

    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, Polysomnographic Study Of Gabapentin 250 mg And 500 mg In Transient Insomnia Induced By A Sleep Phase Advance

Important dates

Study start
2006
Study completion
2006
First posted
May 8, 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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