A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study Of Gabapentin 250 mg And 500 mg In Transient Insomnia Induced By A Sleep Phase Advance

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00674752

Enrollment

377

Registered

2008-05-08

Start date

2006-03-31

Completion date

2006-08-31

Last updated

2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transient Insomnia

Brief 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.

Interventions

DRUGGabapentin

Gabapentin 250 mg oral capsule 30 minutes prior to bedtime

DRUGPlacebo

Matched placebo oral capsule 30 minutes prior to bedtime

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Wake after sleep onset as measured by polysomnography (PSG)	Hour +8

Secondary

Measure	Time frame
PSG Wake Time During Sleep	Hour +8
PSG WASO	Hour +8
PSG Sleep Onset Latency	Hour +8
Vital signs	Hour +8
Karolinska Sleep Diary-Sleep (KSD) Quality Index	Hour +8
KSD individual scores	Hour +8
PSG NA	Hour +8
Adverse events	Hour +13
PSG Total wake time plus Stage 1 sleep	Hour +8
PSG Latency to Persistent Sleep	Hour +8
PSG Sleep Efficiency	Hour +8
PSG Percent of Stages 1, 2, 3, 4 and REM sleep	Hour +8
PSG Percent slow wave sleep (Stages 3&4 combined)	Hour +8
subjective Sleep Latency	Hour +8
subjective Number of Awakenings (NA)	Hour +8
subjective Wake After Sleep Onset (WASO)	Hour +8
subjective Total Sleep Time (TST)	Hour +8
subjective Assessment of Sleep Refreshment	Hour +8
subjective Assessment of Sleep Quality	Hour +8
PSG TST	Hour +8

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026