Efficacy Study of LY2422347 to Treat Insomnia

Study Overview
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Brief Summary
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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).

Official Title
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A Randomized, Double-Blind Comparison of 5 mg of LY2422347, 15 mg of LY2422347, and Placebo in the Treatment of Patients With Primary Insomnia

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Drug: LY2422347
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LY2422347|nan|
|Drug: placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy measure will be Wakening After Sleep Onset (WASO) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |