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

Primary Purpose

Primary Insomnia, Secondary Insomnia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

LY2624803

Placebo

zolpidem

About this trial

This is an interventional treatment trial for Primary Insomnia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Period A

Period B

Period C

Period D

Arm Description

2-week double-blind placebo lead-in period. Period A is the first of four 2-week treatment periods.

Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period B is the second of four 2-week treatment periods.

Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period C is the third of four 2-week treatment periods.

Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period D is the fourth of four 2-week treatment periods.

Outcomes

Primary Outcome Measures

Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint

Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). Analysis of covariance (ANCOVA) Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).

Secondary Outcome Measures

Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint

Unwanted time awake (minutes awake [MA] before sleep [between turning off the lights to first falling asleep], MA during sleep, MA after sleep before getting out of bed). Minimum would be 0; no defined maximum. The higher the number, the more the unwanted time awake. Calculated in minutes from participant-reported daily sleep questionnaire averaged (Avg.) across Period B. Change score subtracts Period B Avg. from Period A Avg. (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group, and insomnia type.

Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint

Elicited from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).

Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint

Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).

Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint

Calculated as (TIB-TTA)/TIB where TIB is time in bed and TTA is total unwanted time awake. Higher score indicates better sleep efficiency. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).

Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint

Assessment of Sleep Quality (ASQ) scale is asked in the participant-reported daily sleep questionnaire; 8 items on 4 point Likert scale with a range of 0 to 24. Sleep experience score ranges from 0-9; awakening experience ranges from 0-15. The higher the score, the better the sleep. Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).

Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint

DCIQ scale is asked in the participant-reported daily evening questionnaire; 5 point Likert scale with minimum of 0 and maximum of 44 (the higher the score, the more consequences of insomnia). Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).

Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint

The ISI is a brief self-report instrument that measures a participant's perception of his or her insomnia. 7 questions on 5-point Likert scale with minimum of 0 and maximum of 28. The higher the score, the more severe the insomnia. It was collected at the bi-weekly office visits. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).

Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint

The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary)

Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint

The EuroQoL Questionnaire-5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. The score ranges 0-100. The higher score indicates a better health state perceived by the participant. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).

Treatment Satisfaction as Measured by the Participant Drug Preference Question

After study Periods A, and B, participants were asked to rate their experience with the treatment they had just completed. Data are presented as percentage of participants preferring the treatment received in Period A (placebo) or treatment received in Period B.

Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint

Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.

Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint

A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.

Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Insomnia Type

Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Insomnia Type

Number of participants with AEs and SAEs. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.

Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Age Group

Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Age Group

Number of participants with AEs and SAEs. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.

Number of Participants With Treatment Emergent Adverse Events (TEAE)

Treatment Emergent Adverse Events (TEAEs) are defined as AEs that first occurred or worsened during the treatment period. TEAEs are summarized by study period and treatment group. TEAEs do not distinguish whether the events were deemed serious. A summary of non-serious AEs is located in the Reported Adverse Event module.

Number of Participants With Serious Adverse Events (SAEs)

SAEs do not distinguish whether the events are treatment-emergent. A summary of SAEs is located in the Reported Adverse Event module.

Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint

Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for systolic blood pressure (SBP) and diastolic blood pressure (DBP) are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.

Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint

Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for pulse rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.

Change From Baseline in Weight at Each 2-week Treatment Endpoint

Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for body weight are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.

Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint

Summary of number of participants with abnormal clinical chemistry, hematology and urinalysis laboratory results. A participant is included in the abnormal category if he/she experienced a result outside the normal reference ranges based on Lilly's reference range in the current period. All analytes have both lower and upper limits. The abnormal number includes both low (below normal range) and high (above normal range).

Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint

Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for heart rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.

Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint

QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF is the QT interval corrected for heart rate using Fridericia formula. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.

Full Information

NCT ID

NCT00784875

First Posted

October 31, 2008

Last Updated

January 30, 2012

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00784875

Brief Title

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

Acronym

SLUMBER

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 Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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. No patient will receive placebo for all four of the 2-week treatment periods. All patients will receive LY2624803 for at least one of the four 2-week treatment 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Insomnia, Secondary Insomnia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

643 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Period A

Arm Type

Experimental

Arm Description

2-week double-blind placebo lead-in period. Period A is the first of four 2-week treatment periods.

Arm Title

Period B

Arm Type

Experimental

Arm Description

Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period B is the second of four 2-week treatment periods.

Arm Title

Period C

Arm Type

Experimental

Arm Description

Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period C is the third of four 2-week treatment periods.

Arm Title

Period D

Arm Type

Experimental

Arm Description

Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period D is the fourth of four 2-week treatment periods.

Intervention Type

Drug

Intervention Name(s)

LY2624803

Intervention Description

1 mg, oral capsule, once nightly before bedtime

Intervention Type

Drug

Intervention Name(s)

LY2624803

Intervention Description

3 mg, oral capsule, once nightly before bedtime

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

matching placebo (capsule or tablet), once nightly before bedtime

Intervention Type

Drug

Intervention Name(s)

zolpidem

Intervention Description

5 or 10 mg, oral tablet, once nightly before bedtime

Primary Outcome Measure Information:

Title

Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint

Description

Time Frame

Baseline, 2 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint

Description

Time Frame

Baseline, 2 weeks

Title

Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint

Description

Time Frame

Baseline, 2 weeks

Title

Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint

Description

Time Frame

Baseline, 2 weeks

Title

Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint

Description

Time Frame

Baseline, 2 weeks

Title

Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint

Description

Time Frame

Baseline, 2 weeks

Title

Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint

Description

Time Frame

Baseline, 2 weeks

Title

Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint

Description

Time Frame

Baseline, 2 weeks

Title

Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint

Description

Time Frame

Baseline, 2 weeks

Title

Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint

Description

Time Frame

Baseline, 2 weeks

Title

Treatment Satisfaction as Measured by the Participant Drug Preference Question

Description

Time Frame

Baseline (Period A) and 2 weeks (Period B)

Title

Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint

Description

Time Frame

2 weeks

Title

Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint

Description

Time Frame

2 weeks

Title

Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Insomnia Type

Description

Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.

Time Frame

Baseline, 2 weeks

Title

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Insomnia Type

Description

Time Frame

Baseline through 8 weeks

Title

Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Age Group

Description

Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.

Time Frame

Baseline, 2 weeks

Title

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Age Group

Description

Number of participants with AEs and SAEs. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.

Time Frame

Baseline through 8 weeks

Title

Number of Participants With Treatment Emergent Adverse Events (TEAE)

Description

Time Frame

Baseline through 8 weeks

Title

Number of Participants With Serious Adverse Events (SAEs)

Description

SAEs do not distinguish whether the events are treatment-emergent. A summary of SAEs is located in the Reported Adverse Event module.

Time Frame

Baseline through 8 weeks

Title

Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint

Description

Time Frame

Baseline, 2 weeks of treatment over 8 weeks

Title

Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint

Description

Time Frame

Baseline, 2 weeks of treatment over 8 weeks

Title

Change From Baseline in Weight at Each 2-week Treatment Endpoint

Description

Time Frame

Baseline, 2 weeks of treatment over 8 weeks

Title

Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint

Description

Time Frame

2 weeks of treatment over 8 weeks

Title

Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint

Description

Time Frame

Baseline, 2 weeks of treatment over 8 weeks

Title

Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint

Description

Time Frame

Baseline, 2 weeks of treatment over 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35213

Country

United States

Facility Name

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85306

Country

United States

Facility Name

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72211

Country

United States

Facility Name

City

Burbank

State/Province

California

ZIP/Postal Code

91505

Country

United States

Facility Name

City

Glendale

State/Province

California

ZIP/Postal Code

91206

Country

United States

Facility Name

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

City

Pismo Beach

State/Province

California

ZIP/Postal Code

93449

Country

United States

Facility Name

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95405

Country

United States

Facility Name

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

City

Denver

State/Province

Colorado

ZIP/Postal Code

80239

Country

United States

Facility Name

City

Fruitland Park

State/Province

Florida

ZIP/Postal Code

34731

Country

United States

Facility Name

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

City

Lauderdale Lakes

State/Province

Florida

ZIP/Postal Code

33319

Country

United States

Facility Name

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751

Country

United States

Facility Name

City

Naples

State/Province

Florida

ZIP/Postal Code

34110

Country

United States

Facility Name

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

City

St Petersburg

State/Province

Florida

ZIP/Postal Code

33707

Country

United States

Facility Name

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Facility Name

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

City

Suwanee

State/Province

Georgia

ZIP/Postal Code

30024

Country

United States

Facility Name

City

Oak Brook

State/Province

Illinois

ZIP/Postal Code

60523

Country

United States

Facility Name

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62711

Country

United States

Facility Name

City

Terre Haute

State/Province

Indiana

ZIP/Postal Code

47802

Country

United States

Facility Name

City

Crestview Hills

State/Province

Kentucky

ZIP/Postal Code

41017

Country

United States

Facility Name

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Facility Name

City

Wellesley Hills

State/Province

Massachusetts

ZIP/Postal Code

02481

Country

United States

Facility Name

City

Sterling Heights

State/Province

Michigan

ZIP/Postal Code

48314

Country

United States

Facility Name

City

Florissant

State/Province

Missouri

ZIP/Postal Code

63033

Country

United States

Facility Name

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89146

Country

United States

Facility Name

City

Bronx

State/Province

New York

ZIP/Postal Code

10454

Country

United States

Facility Name

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11235

Country

United States

Facility Name

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45246

Country

United States

Facility Name

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

City

Jenkintown

State/Province

Pennsylvania

ZIP/Postal Code

19046

Country

United States

Facility Name

City

Lincoln

State/Province

Rhode Island

ZIP/Postal Code

02865

Country

United States

Facility Name

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

City

Austin

State/Province

Texas

ZIP/Postal Code

78756

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98004

Country

United States

Facility Name

City

Lakewood

State/Province

Washington

ZIP/Postal Code

98499

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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