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Efficacy Study of LY2422347 to Treat Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00259311
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : January 26, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE November 28, 2005
First Posted Date  ICMJE November 29, 2005
Last Update Posted Date January 26, 2007
Study Start Date  ICMJE November 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2005)
The primary efficacy measure will be Wakening After Sleep Onset (WASO)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2005)
  • - 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of LY2422347 to Treat Insomnia
Official Title  ICMJE A Randomized, Double-Blind Comparison of 5 mg of LY2422347, 15 mg of LY2422347, and Placebo in the Treatment of Patients With Primary Insomnia
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Sleep Initiation and Maintenance Disorders
Intervention  ICMJE
  • Drug: LY2422347
  • Drug: placebo
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 28, 2005)
400
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00259311
Other Study ID Numbers  ICMJE 9951
H9U-MC-MDBD
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP