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”

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.

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 for 28 days
• Drug: Placebo
  • Matched placebo 30 minutes prior to bedtime for 28 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Gabapentin
• Placebo Comparator: Placebo

Primary Measures

• Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO)
  • Time Frame: Day 1
    Safety Issue?: No

Secondary Measures

• PSG WAPSO
  • Time Frame: Day 28
    Safety Issue?: No
• PSG Latency to Persistent Sleep (LPS)
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• PSG Sleep Onset Latency (SOL)
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• PSG Number of Awakenings (NAW)
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• PSG Wake after Sleep Onset (WASO)
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• PSG Total Wake Time (TWT) plus Stage 1 Sleep
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• PSG Wake Time During Sleep (WTDS)
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• PSG Total Sleep Time (TST)
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• PSG Sleep Efficiency (SE)
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• PSG Percent of Stages 1, 2, 3, 4 and REM sleep
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• PSG Percent Slow Wave Sleep (SWS, Stages 3&4 combined)
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• Subjective SL
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• Subjective NA
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• Subjective WASO
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• Subjective TST
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• Subjective ASR
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• Subjective ASQ
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• Karolinska Sleep Diary (KSD)-Sleep Quality Index
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• KSD individual scores
  • Time Frame: Days 1 and 28
    Safety Issue?: No
• Vital signs
  • Time Frame: Days 1 and 28
    Safety Issue?: Yes
• Adverse events
  • Time Frame: Through Day 32
    Safety Issue?: Yes

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

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 October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00163046

Study ID Number: A9451155

ClinicalTrials.gov Identifier: NCT00163046

Health Authority: United States: Food and Drug Administration

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