Clinical trial NCT00674752: A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Transient Insomnia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-08
Enrollment: 377
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 assess the effect of gabapentin on polysomnographic assessments in transient insomnia induced by a sleep phase advance.


Eligibility criteria: 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

Primary outcomes:
measure: Wake after sleep onset as measured by polysomnography (PSG)
timeFrame: Hour +8
Secondary outcomes:
measure: PSG Latency to Persistent Sleep
timeFrame: Hour +8
measure: PSG Wake Time During Sleep
timeFrame: Hour +8
measure: PSG WASO
timeFrame: Hour +8
measure: PSG Sleep Onset Latency
timeFrame: Hour +8
measure: Vital signs
timeFrame: Hour +8
measure: Karolinska Sleep Diary-Sleep (KSD) Quality Index
timeFrame: Hour +8
measure: KSD individual scores
timeFrame: Hour +8
measure: PSG NA
timeFrame: Hour +8
measure: Adverse events
timeFrame: Hour +13
measure: PSG Total wake time plus Stage 1 sleep
timeFrame: Hour +8
measure: PSG TST
timeFrame: Hour +8
measure: PSG Sleep Efficiency
timeFrame: Hour +8
measure: PSG Percent of Stages 1, 2, 3, 4 and REM sleep
timeFrame: Hour +8
measure: PSG Percent slow wave sleep (Stages 3&4 combined)
timeFrame: Hour +8
measure: subjective Sleep Latency
timeFrame: Hour +8
measure: subjective Number of Awakenings (NA)
timeFrame: Hour +8
measure: subjective Wake After Sleep Onset (WASO)
timeFrame: Hour +8
measure: subjective Total Sleep Time (TST)
timeFrame: Hour +8
measure: subjective Assessment of Sleep Refreshment
timeFrame: Hour +8
measure: subjective Assessment of Sleep Quality
timeFrame: Hour +8
Other outcomes:
Locations:
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Rosenberg RP, Hull SG, Lankford DA, Mayleben DW, Seiden DJ, Furey SA, Jayawardena S, Roth T. A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. J Clin Sleep Med. 2014 Oct 15;10(10):1093-100. doi: 10.5664/jcsm.4108.