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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.309 enrolled

Overview

The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

309

Conditions

Transient Insomnia

Interventions

GabapentinDRUG

Gabapentin 250 mg oral capsule 30 minutes prior to bedtime

GabapentinDRUG

Gabapentin 500 mg oral capsule 30 minutes prior to bedtime

PlaceboDRUG

Matched placebo 30 minutes prior to bedtime

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Pfizer Investigational Site

Glendale, California, United States

Pfizer Investigational Site

San Diego, California, United States

Pfizer Investigational Site

Overland Park, Kansas, United States

Pfizer Investigational Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Latency to persistent sleep as measured by polysomnography

Time frame: Hour +8

Secondary Outcomes

Subjective wake after sleep onset

Time frame: Hour +8

Subjective total sleep time

Time frame: Hour +8

Subjective assessment of sleep refreshment

Time frame: Hour +8

Subjective assessment of sleep quality

Time frame: Hour +8

Stanford Sleepiness Scale

Time frame: Hour +13

Karolinska Sleep Diary-Sleep (KSD) Quality Index

Time frame: Hour +8

KSD individual scores

Time frame: Hour +8

Digit Symbol Substitution Test

Time frame: Hour +8

Latency to REM sleep

Time frame: Hour +8

Number of awakenings

Time frame: Hour +8

Wake after sleep onset

Time frame: Hour +8

Total wake time plus Stage 1 sleep

Time frame: Hour +8

Data from ClinicalTrials.gov

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