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

Eli Lilly and Company1 site in 1 country400 target enrollmentNovember 2005

ConditionsSleep Initiation and Maintenance Disorders

DrugsLY2422347 placebo

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Sleep Initiation and Maintenance Disorders
Sponsor: Eli Lilly and Company
Enrollment: 400
Locations: 1
Primary Endpoint: The primary efficacy measure will be Wakening After Sleep Onset (WASO)
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

November 2006

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility 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.

Outcomes

Primary 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
Safety and tolerability of LY2422347 compared with placebo