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

Transient Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666770
• Other study ID #: A9451139
• Status: Completed
• Phase: Phase 3
• Start date: October 2004
• Est. completion date: November 2004

Study information

• Verified date: April 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders
• Transient Insomnia

Intervention

Drug:
• Gabapentin
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
• Gabapentin
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
• Placebo
Matched placebo 30 minutes prior to bedtime

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Glendale	California
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Latency to persistent sleep as measured by polysomnography		Hour +8
Secondary	Subjective wake after sleep onset		Hour +8
Secondary	Subjective total sleep time		Hour +8
Secondary	Subjective assessment of sleep refreshment		Hour +8
Secondary	Subjective assessment of sleep quality		Hour +8
Secondary	Stanford Sleepiness Scale		Hour +13
Secondary	Karolinska Sleep Diary-Sleep (KSD) Quality Index		Hour +8
Secondary	KSD individual scores		Hour +8
Secondary	Digit Symbol Substitution Test		Hour +8
Secondary	Latency to REM sleep		Hour +8
Secondary	Number of awakenings		Hour +8
Secondary	Wake after sleep onset		Hour +8
Secondary	Total wake time plus Stage 1 sleep		Hour +8
Secondary	Total sleep time		Hour +8
Secondary	Sleep efficiency		Hour +8
Secondary	Percent of Stages 1, 2, 3, 4 (non-REM) and REM sleep		Hour +8
Secondary	Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)		Hour +8
Secondary	Vital signs		Hour +8
Secondary	Adverse events		Hour +13
Secondary	Sleep onset latency		Hour +8
Secondary	Percent slow wave sleep (Stages 3&4 combined)		Hour +8
Secondary	Subjective sleep latency		Hour +8
Secondary	Subjective number of awakenings		Hour +8

External Links

•   To obtain contact information for a study center near you, click here.