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”

The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in transient insomnia induced by a sleep phase advance.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Experimental: B
• Placebo Comparator: C

Primary Measures

• Wake after sleep onset as measured by polysomnography (PSG)
  • Time Frame: Hour +8
    Safety Issue?: No

Secondary Measures

• PSG Latency to Persistent Sleep
  • Time Frame: Hour +8
    Safety Issue?: No
• PSG Wake Time During Sleep
  • Time Frame: Hour +8
    Safety Issue?: No
• PSG WASO
  • Time Frame: Hour +8
    Safety Issue?: No
• PSG Sleep Onset Latency
  • Time Frame: Hour +8
    Safety Issue?: No
• Vital signs
  • Time Frame: Hour +8
    Safety Issue?: No
• Karolinska Sleep Diary-Sleep (KSD) Quality Index
  • Time Frame: Hour +8
    Safety Issue?: No
• KSD individual scores
  • Time Frame: Hour +8
    Safety Issue?: No
• PSG NA
  • Time Frame: Hour +8
    Safety Issue?: No
• Adverse events
  • Time Frame: Hour +13
    Safety Issue?: Yes
• PSG Total wake time plus Stage 1 sleep
  • Time Frame: Hour +8
    Safety Issue?: No
• PSG TST
  • Time Frame: Hour +8
    Safety Issue?: No
• PSG Sleep Efficiency
  • Time Frame: Hour +8
    Safety Issue?: No
• PSG Percent of Stages 1, 2, 3, 4 and REM sleep
  • Time Frame: Hour +8
    Safety Issue?: No
• PSG Percent slow wave sleep (Stages 3&4 combined)
  • Time Frame: Hour +8
    Safety Issue?: No
• subjective Sleep Latency
  • Time Frame: Hour +8
    Safety Issue?: No
• subjective Number of Awakenings (NA)
  • Time Frame: Hour +8
    Safety Issue?: No
• subjective Wake After Sleep Onset (WASO)
  • Time Frame: Hour +8
    Safety Issue?: No
• subjective Total Sleep Time (TST)
  • Time Frame: Hour +8
    Safety Issue?: No
• subjective Assessment of Sleep Refreshment
  • Time Frame: Hour +8
    Safety Issue?: No
• subjective Assessment of Sleep Quality
  • Time Frame: Hour +8
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00674752

Study ID Number: A9451157

ClinicalTrials.gov Identifier: NCT00674752

Health Authority: United States: Food and Drug Administration

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