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Efficacy Study of LY2422347 to Treat Insomnia

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00259311
First received: November 28, 2005
Last updated: January 24, 2007
Last verified: January 2007
History of Changes
  Purpose
The purpose of this study is to determine whether a compound known as LY2422347 is effective in treating people diagnosed with primary insomnia (difficulty sleeping with no other significant contributing factor, such as depression).

Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
 Drug: LY2422347
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Comparison of 5 mg of LY2422347, 15 mg of LY2422347, and Placebo in the Treatment of Patients With Primary Insomnia

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • The primary efficacy measure will be Wakening After Sleep Onset (WASO)

Secondary Outcome Measures:
  • Wake Time During Sleep (WTDS) and Wake Time After Sleep (WTAS)
  • improvement of daily subjective sleep quality at endpoint
  • reduction in the Number of Awakenings or Arousal Index and increase of time spent in Slow Wave Sleep (SWS) and various other parameters at endpoint as measured with PSG
  • Various characteristics of sleep and daytime functioning assessed with biweekly self-report questionnaires at endpoint
  • increase in subjective sleep efficiency at endpoint as assessed by the patient's daily diary
  • Clinician Global Impression of Improvement (CGI-I) score at endpoint
  • improvement at endpoint on the biweekly subjective assessment of physical role functioning, emotional role functioning, vitality, social functioning, and mental health using the Short Form-12
  • Safety and tolerability of LY2422347 compared with placebo
Estimated Enrollment: 400
Study Start Date: November 2005
Estimated Study Completion Date: November 2006
  Eligibility
Ages Eligible for Study:   24 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • must have been diagnosed with primary insomnia
  • must not be significantly overweight
  • must be able to visit the study doctor's office once every 2 weeks for 8 weeks and willing to use a handheld electronic device as a sleep diary every day
  • must be able to read and speak in English and be able to see well enough to use the handheld electronic device
  • the patient's answer to the question "During the past month, how would you rate your sleep quality overall?" must be either "Very Bad" or "Fairly Bad"

Exclusion Criteria:

  • cannot have a clinically significant and/or uncontrolled condition or other significant ailment including restless leg syndrome (RLS) or periodic limb movement disorder (PLMD)
  • cannot have obstructive sleep apnea (OSA), or be considered by the study doctor to have probable OSA based upon patient history and physical examination
  • cannot be currently using antidepressants, antipsychotics, stimulants, antihistaminics, or other medications that are known to effect sleep
  • cannot have a current or previous major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder, social anxiety, or another psychotic disorder.
  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: NCT00259311

  Show 22 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

ClinicalTrials.gov Identifier: NCT00259311     History of Changes
Other Study ID Numbers: 9951  H9U-MC-MDBD 
Study First Received: November 28, 2005
Last Updated: January 24, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on September 27, 2016