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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00666770

Purpose

The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.

Condition	Intervention	Phase
Transient Insomnia	Drug: Gabapentin Drug: Placebo	Phase III

Drug Information available for: Gabapentin

U.S. FDA Resources

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Latency to persistent sleep as measured by polysomnography [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subjective wake after sleep onset [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Subjective total sleep time [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Subjective assessment of sleep refreshment [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Subjective assessment of sleep quality [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Stanford Sleepiness Scale [ Time Frame: Hour +13 ] [ Designated as safety issue: No ]
Karolinska Sleep Diary-Sleep (KSD) Quality Index [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
KSD individual scores [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Digit Symbol Substitution Test [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Latency to REM sleep [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Number of awakenings [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Wake after sleep onset [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Total wake time plus Stage 1 sleep [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Total sleep time [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Sleep efficiency [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Percent of Stages 1, 2, 3, 4 (non-REM) and REM sleep [ Time Frame: Hour +8 ] [ Designated as 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 ] [ Designated as safety issue: No ]
Vital signs [ Time Frame: Hour +8 ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: Hour +13 ] [ Designated as safety issue: Yes ]
Sleep onset latency [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Percent slow wave sleep (Stages 3&4 combined) [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Subjective sleep latency [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Subjective number of awakenings [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]

Enrollment:	309
Study Start Date:	October 2004
Study Completion Date:	November 2004

Arms	Assigned Interventions
Gabapentin 250 mg: Experimental	Drug: Gabapentin Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
Gabapentin 500 mg: Experimental	Drug: Gabapentin Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
Placebo: Placebo Comparator	Drug: Placebo Matched placebo 30 minutes prior to bedtime

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666770

Locations

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

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A9451139
Study First Received:	April 23, 2008
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00666770
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Excitatory Amino Acids
Calcium, Dietary
Gabapentin

Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Cardiovascular Agents

Antimanic Agents
Pharmacologic Actions
Membrane Transport Modulators
Sensory System Agents
Therapeutic Uses
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009