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

Condition(s) targeted: Primary Insomnia; Secondary Insomnia

Intervention: LY2624803 (Drug); LY2624803 (Drug); Placebo (Drug); zolpidem (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

Overall contact:
There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559

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.

Official title: A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study of the Safety and Efficacy of LY2624803 in Outpatients With Insomnia

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Primary outcome: Average nightly Total Sleep Time calculated from patient-reported daily sleep questionnaire data

Secondary outcome:

Comparison of zolpidem to placebo on mean change in Total Sleep Time

Comparison of LY2624803 3 mg with zolpidem to mean change in Total Sleep Time

Comparison of LY2624803 to placebo and LY2624803 to zolpidem on mean changes from baseline in unwanted time awake (measured by minutes awake before sleep, minutes awake during sleep, minutes awake after sleep)

Comparison of LY2624803 to placebo and LY2624803 to zolpidem on mean changes from baseline in number of awakenings during sleep

Comparison of LY2624803 to placebo and LY2624803 to zolpidem on mean changes from baseline in total time awake

Comparison of LY2624803 to placebo and LY2624803 to zolpidem on mean changes from baseline in sleep efficiency

Comparison of LY2624803 to placebo and LY2624803 to zolpidem on patients' subjective satisfaction with sleep and/or sleep quality, measured by mean changes from baseline in Assessment of Sleep Quality

Comparison of LY2624803 to placebo and LY2624803 to zolpidem on patients' impression of daytime functioning, measured by mean changes from baseline in Daily Consequences of Insomnia Questionnaire

Comparison of LY2624803 to placebo and LY2624803 to zolpidem on mean changes from baseline in the Insomnia Severity Index

Comparison of LY2624803 to placebo and LY2624803 to zolpidem on measures of health-related quality of life as measured by mean changes from baseline in SF-12

Comparison of LY2624803 to placebo and LY2624803 to zolpidem on measures of health-related quality of life as measured by mean changes from baseline in EuroQol

Comparison of LY2624803 to placebo and LY2624803 to zolpidem on treatment satisfaction as measured by the Patient Drug Preference question

Comparison of LY2624803 to placebo and LY2624803 to zolpidem on Clinical Global Impression of Improvement (CGI-I)in insomnia

Comparison of LY2624803 to placebo and LY2624803 to zolpidem on Patient Global Impression of Improvement (PGI-I)in insomnia

Comparison of efficacy and safety of LY2624803, zolpidem, and placebo in patients with primary insomnia to efficacy and safety of those treatments in patients with secondary insomnia

Comparison of efficacy and safety of LY2624803, zolpidem, and placebo in patients under age 65 to efficacy and safety of those treatments in patients over age 65

Comparison of safety and tolerability of LY2624803 to placebo as measured by spontaneous adverse event reports. Reported as Summary of Treatment Emergent Adverse Events

Comparison of safety and tolerability of LY2624803 to placebo as measured by serious adverse event reports. Reported as Summary of SAEs.

Comparison of safety and tolerability of LY2624803 to placebo as measured by vital signs.

Comparison of safety and tolerability of LY2624803 to placebo as measured by laboratory analytes.

Comparison of safety and tolerability of LY2624803 to placebo as measured by ECGs

Detailed description: Outpatients with chronic insomnia who participate in this study will be treated in each of four 2-week treatment periods with bedtime doses of either placebo, zolpidem, LY2624803 1 mg, or LY2624803 3 mg. Neither patients nor investigators will be told what treatments are being given in any treatment period. A patient who completes all four treatment periods will be treated with placebo in 1, 2, or 3 of the periods; with zolpidem in 0, 1, or 2 of the periods; and with LY2624803 in either 1 or 2 of the periods. During each treatment period, patients will record information each morning about their sleep the night before, and each evening about their functioning since waking up. Patients will also wear wrist actigraphy devices to record their physical activity. At the conclusion of each treatment period, patients will answer questions about their sleep, functioning, health, and relative preference for treatments.

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559

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., Birmingham, Alabama 35213, United States; Recruiting
Eli Lilly

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Eli Lilly

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Starting date: October 2008
Ending date: July 2010
Last updated: October 5, 2009