NCT Number: NCT00259311
Efficacy Study of LY2422347 to Treat Insomnia
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).
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Notify MeKey information
Conditions
Age range
24 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Phoenix, Arizona, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Placebo
DrugPrimary outcomes
-
The primary efficacy measure will be Wakening After Sleep Onset (WASO)
Secondary outcomes
-
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
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Safety and tolerability of LY2422347 compared with placebo
Sponsors and collaborators
Lead sponsor
Eli Lilly and Company
Industry
Registry information
Official study 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
Important dates
- Study start
- 2005
- Study completion
- 2006
- First posted
- Nov 29, 2005
- Registry last updated
- Jan 26, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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