Overview

A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Gabapentin
gamma-Aminobutyric Acid
Criteria
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