CompletedPhase 3

A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

United States256 participantsStarted 2005-10

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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

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

What they're measuring

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

Timeframe: Day 1

Trial details

NCT IDNCT00163046

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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