A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

Transient Insomnia Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 28-day, Polysomnographic Study of Gabapentin 250 mg in Transient Insomnia Induced by a Sleep Phase Advance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163046
• Other study ID #: A9451155
• Status: Completed
• Phase: Phase 3
• Start date: October 2005
• Est. completion date: April 2006

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 to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with transient insomnia induced by a sleep phase advance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older with occasional sleeplessness in the month prior to screening

Exclusion Criteria:

• Current treatment for, or recent history (within 2 years) of, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition that interferes with the subject's sleep

• Currently taking or expected to take any of the following during trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbiturates, and phencyclidine during their participation in the trial

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders
• Transient Insomnia

Intervention

Drug:
• Gabapentin
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days
• Placebo
Matched placebo 30 minutes prior to bedtime for 28 days

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Glendale	California
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	Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO)		Day 1
Secondary	PSG WAPSO		Day 28
Secondary	PSG Latency to Persistent Sleep (LPS)		Days 1 and 28
Secondary	PSG Sleep Onset Latency (SOL)		Days 1 and 28
Secondary	PSG Number of Awakenings (NAW)		Days 1 and 28
Secondary	PSG Wake after Sleep Onset (WASO)		Days 1 and 28
Secondary	PSG Total Wake Time (TWT) plus Stage 1 Sleep		Days 1 and 28
Secondary	PSG Wake Time During Sleep (WTDS)		Days 1 and 28
Secondary	PSG Total Sleep Time (TST)		Days 1 and 28
Secondary	PSG Sleep Efficiency (SE)		Days 1 and 28
Secondary	PSG Percent of Stages 1, 2, 3, 4 and REM sleep		Days 1 and 28
Secondary	PSG Percent Slow Wave Sleep (SWS, Stages 3&4 combined)		Days 1 and 28
Secondary	Subjective SL		Days 1 and 28
Secondary	Subjective NA		Days 1 and 28
Secondary	Subjective WASO		Days 1 and 28
Secondary	Subjective TST		Days 1 and 28
Secondary	Subjective ASR		Days 1 and 28
Secondary	Subjective ASQ		Days 1 and 28
Secondary	Karolinska Sleep Diary (KSD)-Sleep Quality Index		Days 1 and 28
Secondary	KSD individual scores		Days 1 and 28
Secondary	Vital signs		Days 1 and 28
Secondary	Adverse events		Through Day 32

External Links

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