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 as compared to placebo on sleep in subjects with transient insomnia.

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 30 minutes prior to bedtime

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Gabapentin 250 mg
• Experimental: Gabapentin 500 mg
• Placebo Comparator: Placebo

Primary Measures

• Latency to persistent sleep as measured by polysomnography
  • Time Frame: Hour +8
    Safety Issue?: No

Secondary Measures

• Subjective wake after sleep onset
  • Time Frame: Hour +8
    Safety Issue?: No
• Subjective total sleep time
  • 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
• Stanford Sleepiness Scale
  • Time Frame: Hour +13
    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
• Digit Symbol Substitution Test
  • Time Frame: Hour +8
    Safety Issue?: No
• Latency to REM sleep
  • Time Frame: Hour +8
    Safety Issue?: No
• Number of awakenings
  • Time Frame: Hour +8
    Safety Issue?: No
• Wake after sleep onset
  • Time Frame: Hour +8
    Safety Issue?: No
• Total wake time plus Stage 1 sleep
  • Time Frame: Hour +8
    Safety Issue?: No
• Total sleep time
  • Time Frame: Hour +8
    Safety Issue?: No
• Sleep efficiency
  • Time Frame: Hour +8
    Safety Issue?: No
• Percent of Stages 1, 2, 3, 4 (non-REM) and REM sleep
  • Time Frame: Hour +8
    Safety Issue?: No
• Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)
  • Time Frame: Hour +8
    Safety Issue?: No
• Vital signs
  • Time Frame: Hour +8
    Safety Issue?: Yes
• Adverse events
  • Time Frame: Hour +13
    Safety Issue?: Yes
• Sleep onset latency
  • Time Frame: Hour +8
    Safety Issue?: No
• 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
  • Time Frame: Hour +8
    Safety Issue?: No

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

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 September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00666770

Study ID Number: A9451139

ClinicalTrials.gov Identifier: NCT00666770

Health Authority: United States: Food and Drug Administration

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