An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare an investigational drug (LY2624803) with placebo and with zolpidem in the treatment of outpatients with chronic insomnia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Zolpidem

Criteria

Inclusion Criteria:

• Patients must be between 18 and 85 years of age, with a stable living situation

• Clinical diagnosis of either primary insomnia or "secondary" insomnia (comorbid with depression, anxiety, and/or medical illness)

• Insomnia systems must be at least moderate in severity within the month prior to study entry, and must include difficulty staying asleep and/or problems with awakening earlier than desired

• Psychiatric and medical conditions present must be stable over the 3 months prior to study entry, and not expected to worsen significantly or require hospitalization during participation in the study

• Ongoing treatments for psychiatric and medical conditions present must have been stable for the 3 months prior to study entry, and must be expected to remain stable during participation in the study

• Patients must be willing to abstain from taking medications (other than study drug) to help them sleep during participation in the study

• Patients must be willing to consistently spend at least 7 hours each night either sleeping or trying to sleep during participation in the study

• Patients must be able to speak and read English and be capable of using a computer with a web browser (computers with internet connections will be provided to patients who need them)

Exclusion Criteria:

• Unusual or unstable sleep/wake schedule, such as with rotating shift work

• Severe or unstable psychiatric or medical illness

• Suicidal ideation

• Substance abuse

• Known obstructive sleep apnea, restless leg syndrome, or periodic limb movement disorder

• History of seizures

• Body Mass Index > 33

• Clinically significant abnormality in clinical chemistry, hematology, urinalysis, and/or electrocardiogram

• Anticipated inability to regularly use a medication which might reduce motor or cognitive functioning during sleeping hours, such as a person who might often need to be "on call", drive a car, or be responsible for the care of another person during sleeping hours

• Contraindication to zolpidem

• History of breast cancer

• An estimated glomerular filtration rate (GFR; an index of renal function) that is <30 mL/min at study entry