CompletedPhase 3

A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

United States377 participantsStarted 2006-03

Plain-language summary

The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in transient insomnia induced by a sleep phase advance.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Wake after sleep onset as measured by polysomnography (PSG)

Timeframe: Hour +8

Trial details

NCT IDNCT00674752

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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