An Efficacy Study of Compound LY2624803 in the Treatment of Patients 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”

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.

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.

Intervention(s) in this Clinical Trial

• Drug: LY2624803
  • 1 mg, oral capsule, once nightly before bedtime
• Drug: LY2624803
  • 3 mg, oral capsule, once nightly before bedtime
• Drug: Placebo
  • matching placebo (capsule or tablet), once nightly before bedtime
• Drug: zolpidem
  • 5 or 10 mg, oral tablet, once nightly before bedtime

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. No patient will receive placebo for all 2-week treatment periods. All patients will receive LY2624803 for at least one 2-week treatment period.
• Experimental: 2
  • Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. No patient will receive placebo for all 2-week treatment periods. All patients will receive LY2624803 for at least one 2-week treatment period.
• Experimental: 3
  • Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. No patient will receive placebo for all 2-week treatment periods. All patients will receive LY2624803 for at least one 2-week treatment period.
• Experimental: 4
  • Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. No patient will receive placebo for all 2-week treatment periods. All patients will receive LY2624803 for at least one 2-week treatment period.

Primary Measures

• Average nightly Total Sleep Time calculated from patient-reported daily sleep questionnaire data
  • Time Frame: 2 weeks
    Safety Issue?: No

Secondary Measures

• Comparison of zolpidem to placebo on mean change in Total Sleep Time
  • Time Frame: 2 weeks
    Safety Issue?: No
• Comparison of LY2624803 3 mg with zolpidem to mean change in Total Sleep Time
  • Time Frame: 2 weeks
    Safety Issue?: No
• 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)
  • Time Frame: baseline, 2 weeks
    Safety Issue?: No
• Comparison of LY2624803 to placebo and LY2624803 to zolpidem on mean changes from baseline in number of awakenings during sleep
  • Time Frame: baseline, 2 weeks
    Safety Issue?: No
• Comparison of LY2624803 to placebo and LY2624803 to zolpidem on mean changes from baseline in total time awake
  • Time Frame: baseline, 2 weeks
    Safety Issue?: No
• Comparison of LY2624803 to placebo and LY2624803 to zolpidem on mean changes from baseline in sleep efficiency
  • Time Frame: baseline, 2 weeks
    Safety Issue?: No
• 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
  • Time Frame: baseline, 2 weeks
    Safety Issue?: No
• 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
  • Time Frame: baseline, 2 weeks
    Safety Issue?: No
• Comparison of LY2624803 to placebo and LY2624803 to zolpidem on mean changes from baseline in the Insomnia Severity Index
  • Time Frame: baseline, 2 weeks
    Safety Issue?: No
• 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
  • Time Frame: baseline, 2 weeks
    Safety Issue?: No
• 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
  • Time Frame: baseline, 2 weeks
    Safety Issue?: No
• Comparison of LY2624803 to placebo and LY2624803 to zolpidem on treatment satisfaction as measured by the Patient Drug Preference question
  • Time Frame: 2 weeks
    Safety Issue?: No
• Comparison of LY2624803 to placebo and LY2624803 to zolpidem on Clinical Global Impression of Improvement (CGI-I)in insomnia
  • Time Frame: 2 weeks
    Safety Issue?: No
• Comparison of LY2624803 to placebo and LY2624803 to zolpidem on Patient Global Impression of Improvement (PGI-I)in insomnia
  • Time Frame: 2 weeks
    Safety Issue?: No
• 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
  • Time Frame: 2 weeks
    Safety Issue?: Yes
• 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
  • Time Frame: 2 weeks
    Safety Issue?: Yes
• Comparison of safety and tolerability of LY2624803 to placebo as measured by spontaneous adverse event reports. Reported as Summary of Treatment Emergent Adverse Events
  • Time Frame: 8 weeks
    Safety Issue?: Yes
• Comparison of safety and tolerability of LY2624803 to placebo as measured by serious adverse event reports. Reported as Summary of SAEs.
  • Time Frame: 8 weeks
    Safety Issue?: Yes
• Comparison of safety and tolerability of LY2624803 to placebo as measured by vital signs.
  • Time Frame: 8 weeks
    Safety Issue?: Yes
• Comparison of safety and tolerability of LY2624803 to placebo as measured by laboratory analytes.
  • Time Frame: 8 weeks
    Safety Issue?: Yes
• Comparison of safety and tolerability of LY2624803 to placebo as measured by ECGs
  • Time Frame: 8 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

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 Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00784875

Study ID Number: 12063

ClinicalTrials.gov Identifier: NCT00784875

Health Authority: United States: Food and Drug Administration