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

NCT00163046 | Completed Phase 3

• 1 other identifier: A9451155
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Transient Insomnia

Outcome Measures

Primary Outcomes (1)

• Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO)

  Day 1

Secondary Outcomes (21)

• PSG WAPSO

  Day 28

• PSG Latency to Persistent Sleep (LPS)

  Days 1 and 28

• PSG Sleep Onset Latency (SOL)

  Days 1 and 28

• PSG Number of Awakenings (NAW)

  Days 1 and 28

• PSG Wake after Sleep Onset (WASO)

  Days 1 and 28

Study Arms (2)

Gabapentin

EXPERIMENTAL

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Gabapentin DRUG

Gabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days

Gabapentin

Placebo DRUG

Matched placebo 30 minutes prior to bedtime for 28 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older with occasional sleeplessness in the month prior to screening

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (3)

Pfizer Investigational Site

Glendale, California, 91206, United States

Location

Pfizer Investigational Site

San Diego, California, 92123, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66212, United States

Location

Related Publications (1)

• Furey SA, Hull SG, Leibowitz MT, Jayawardena S, Roth T. A randomized, double-blind, placebo-controlled, multicenter, 28-day, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. J Clin Sleep Med. 2014 Oct 15;10(10):1101-9. doi: 10.5664/jcsm.4110.

  PMID: 25317091 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 13, 2005
• Study Start: October 1, 2005
• Study Completion: April 1, 2006
• Last Updated: February 2, 2021

Record last verified: 2008-04

Locations

US (3)