An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00784875

Purpose

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.

Condition	Intervention	Phase
Primary Insomnia Secondary Insomnia	Drug: LY2624803 Drug: Placebo Drug: zolpidem	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Zolpidem

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Average nightly Total Sleep Time calculated from patient-reported daily sleep questionnaire data [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of zolpidem to placebo on mean change in Total Sleep Time [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Comparison of LY2624803 3 mg with zolpidem to mean change in Total Sleep Time [ Time Frame: 2 weeks ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]
Comparison of safety and tolerability of LY2624803 to placebo as measured by vital signs. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Comparison of safety and tolerability of LY2624803 to placebo as measured by laboratory analytes. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Comparison of safety and tolerability of LY2624803 to placebo as measured by ECGs [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	676
Study Start Date:	October 2008
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: LY2624803 1 mg, oral capsule, once nightly before bedtime Other Name: LY2624803 Drug: LY2624803 3 mg, oral capsule, once nightly before bedtime Other Name: LY2624803 Drug: Placebo matching placebo (capsule or tablet), once nightly before bedtime Drug: zolpidem 5 or 10 mg, oral tablet, once nightly before bedtime
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.	Drug: LY2624803 1 mg, oral capsule, once nightly before bedtime Other Name: LY2624803 Drug: LY2624803 3 mg, oral capsule, once nightly before bedtime Other Name: LY2624803 Drug: Placebo matching placebo (capsule or tablet), once nightly before bedtime Drug: zolpidem 5 or 10 mg, oral tablet, once nightly before bedtime
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.	Drug: LY2624803 1 mg, oral capsule, once nightly before bedtime Other Name: LY2624803 Drug: LY2624803 3 mg, oral capsule, once nightly before bedtime Other Name: LY2624803 Drug: Placebo matching placebo (capsule or tablet), once nightly before bedtime Drug: zolpidem 5 or 10 mg, oral tablet, once nightly before bedtime
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.	Drug: LY2624803 1 mg, oral capsule, once nightly before bedtime Other Name: LY2624803 Drug: LY2624803 3 mg, oral capsule, once nightly before bedtime Other Name: LY2624803 Drug: Placebo matching placebo (capsule or tablet), once nightly before bedtime Drug: zolpidem 5 or 10 mg, oral tablet, once nightly before bedtime

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784875

Show 49 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00784875 History of Changes
Other Study ID Numbers:	12063, I2K-MC-ZZAD
Study First Received:	October 31, 2008
Last Updated:	December 9, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012