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A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00163046
First received: September 8, 2005
Last updated: April 23, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Transient Insomnia
Drug: Gabapentin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

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

Enrollment: 256
Study Start Date: October 2005
Study Completion Date: April 2006
Arms Assigned Interventions
Experimental: Gabapentin Drug: Gabapentin
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days
Placebo Comparator: Placebo Drug: Placebo
Matched placebo 30 minutes prior to bedtime for 28 days

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163046

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, 66212
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00163046     History of Changes
Other Study ID Numbers: A9451155
Study First Received: September 8, 2005
Last Updated: April 23, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Dyssomnias
Mental Disorders
Nervous System Diseases
Sleep Disorders
Sleep Disorders, Intrinsic
Gabapentin
Analgesics
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antimanic Agents
Antiparkinson Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 19, 2014