Efficacy Study of LY2422347 to Treat Insomnia

Eli Lilly and Company400 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

LY2422347DRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 24 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (22)

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

Data from ClinicalTrials.gov

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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

Anaheim, California, United States

Burbank, California, United States

Los Angeles, California, United States

Pismo Beach, California, United States

San Diego, California, United States

Denver, Colorado, United States

Jacksonville, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

...and 12 more locations