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Efficacy Study of LY2422347 to Treat Insomnia

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ClinicalTrials.gov Identifier: NCT00259311
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : January 26, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Drug: LY2422347 Drug: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : November 2005
Estimated Study Completion Date : November 2006
Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. Wake Time During Sleep (WTDS) and Wake Time After Sleep (WTAS)
  2. improvement of daily subjective sleep quality at endpoint
  3. 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
  4. Various characteristics of sleep and daytime functioning assessed with biweekly self-report questionnaires at endpoint
  5. increase in subjective sleep efficiency at endpoint as assessed by the patient's daily diary
  6. Clinician Global Impression of Improvement (CGI-I) score at endpoint
  7. 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
  8. Safety and tolerability of LY2422347 compared with placebo

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: January 26, 2007
Last Verified: January 2007

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