Clinical trial NCT00163046: A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Transient Insomnia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO)
timeFrame: Day 1
Secondary outcomes:
measure: PSG WAPSO
timeFrame: Day 28
measure: PSG Latency to Persistent Sleep (LPS)
timeFrame: Days 1 and 28
measure: PSG Sleep Onset Latency (SOL)
timeFrame: Days 1 and 28
measure: PSG Number of Awakenings (NAW)
timeFrame: Days 1 and 28
measure: PSG Wake after Sleep Onset (WASO)
timeFrame: Days 1 and 28
measure: PSG Total Wake Time (TWT) plus Stage 1 Sleep
timeFrame: Days 1 and 28
measure: PSG Wake Time During Sleep (WTDS)
timeFrame: Days 1 and 28
measure: PSG Total Sleep Time (TST)
timeFrame: Days 1 and 28
measure: PSG Sleep Efficiency (SE)
timeFrame: Days 1 and 28
measure: PSG Percent of Stages 1, 2, 3, 4 and REM sleep
timeFrame: Days 1 and 28
measure: PSG Percent Slow Wave Sleep (SWS, Stages 3&4 combined)
timeFrame: Days 1 and 28
measure: Subjective SL
timeFrame: Days 1 and 28
measure: Subjective NA
timeFrame: Days 1 and 28
measure: Subjective WASO
timeFrame: Days 1 and 28
measure: Subjective TST
timeFrame: Days 1 and 28
measure: Subjective ASR
timeFrame: Days 1 and 28
measure: Subjective ASQ
timeFrame: Days 1 and 28
measure: Karolinska Sleep Diary (KSD)-Sleep Quality Index
timeFrame: Days 1 and 28
measure: KSD individual scores
timeFrame: Days 1 and 28
measure: Vital signs
timeFrame: Days 1 and 28
measure: Adverse events
timeFrame: Through Day 32
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Furey SA, Hull SG, Leibowitz MT, Jayawardena S, Roth T. A randomized, double-blind, placebo-controlled, multicenter, 28-day, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. J Clin Sleep Med. 2014 Oct 15;10(10):1101-9. doi: 10.5664/jcsm.4110.