Overview

A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

Status:
Completed
Trial end date:
2004-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.
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

- 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)

- Recreational drug use within past 30 days