A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00666770
Recruitment Status : Completed
First Posted : April 25, 2008
Last Update Posted : April 25, 2008
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Brief Summary:
The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.

Condition or disease Intervention/treatment Phase
Transient Insomnia Drug: Gabapentin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 309 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2004
Actual Study Completion Date : November 2004

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: Gabapentin 250 mg Drug: Gabapentin
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
Experimental: Gabapentin 500 mg Drug: Gabapentin
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
Placebo Comparator: Placebo Drug: Placebo
Matched placebo 30 minutes prior to bedtime

Primary Outcome Measures :
  1. Latency to persistent sleep as measured by polysomnography [ Time Frame: Hour +8 ]

Secondary Outcome Measures :
  1. Subjective wake after sleep onset [ Time Frame: Hour +8 ]
  2. Subjective total sleep time [ Time Frame: Hour +8 ]
  3. Subjective assessment of sleep refreshment [ Time Frame: Hour +8 ]
  4. Subjective assessment of sleep quality [ Time Frame: Hour +8 ]
  5. Stanford Sleepiness Scale [ Time Frame: Hour +13 ]
  6. Karolinska Sleep Diary-Sleep (KSD) Quality Index [ Time Frame: Hour +8 ]
  7. KSD individual scores [ Time Frame: Hour +8 ]
  8. Digit Symbol Substitution Test [ Time Frame: Hour +8 ]
  9. Latency to REM sleep [ Time Frame: Hour +8 ]
  10. Number of awakenings [ Time Frame: Hour +8 ]
  11. Wake after sleep onset [ Time Frame: Hour +8 ]
  12. Total wake time plus Stage 1 sleep [ Time Frame: Hour +8 ]
  13. Total sleep time [ Time Frame: Hour +8 ]
  14. Sleep efficiency [ Time Frame: Hour +8 ]
  15. Percent of Stages 1, 2, 3, 4 (non-REM) and REM sleep [ Time Frame: Hour +8 ]
  16. Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score) [ Time Frame: Hour +8 ]
  17. Vital signs [ Time Frame: Hour +8 ]
  18. Adverse events [ Time Frame: Hour +13 ]
  19. Sleep onset latency [ Time Frame: Hour +8 ]
  20. Percent slow wave sleep (Stages 3&4 combined) [ Time Frame: Hour +8 ]
  21. Subjective sleep latency [ Time Frame: Hour +8 ]
  22. Subjective number of awakenings [ Time Frame: Hour +8 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00666770

United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
Pfizer Investigational Site
San Diego, California, United States, 92123
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10025
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00666770     History of Changes
Other Study ID Numbers: A9451139
First Posted: April 25, 2008    Key Record Dates
Last Update Posted: April 25, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
gamma-Aminobutyric Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents