Primary InsomniaPhase 2SLUMBERNCT00784875

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

A Phase 2 study testing LY2624803 and zolpidem in people with Primary Insomnia and Secondary Insomnia, run by Eli Lilly and Company at 49 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Primary Insomnia, Secondary Insomnia
What is being tested?: LY2624803 and zolpidem
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 643 participants
Where: 49 sitesUnited States
Study dates: Oct 2008to Feb 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

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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

Trial locations and contacts

49 sites in 1 country.

City, postcode or hospital

49 sites in 1 country

United States49 sites

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.
Anderson, South Carolina, 29621
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Atlanta, Georgia, 30342
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Austin, Texas, 78756
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Bellevue, Washington, 98004
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Birmingham, Alabama, 35213
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Brooklyn, New York, 11235
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Burbank, California, 91505
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Chevy Chase, Maryland, 20815
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Cincinnati, Ohio, 45246
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Cleveland, Ohio, 44122
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Crestview Hills, Kentucky, 41017
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Dallas, Texas, 75231
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Denver, Colorado, 80239
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Florissant, Missouri, 63033
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Fruitland Park, Florida, 34731
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Glendale, Arizona, 85306
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Glendale, California, 91206
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Hialeah, Florida, 33012
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Hickory, North Carolina, 28601
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Jenkintown, Pennsylvania, 19046
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Lakewood, Washington, 98499
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Las Vegas, Nevada, 89146
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Lauderdale Lakes, Florida, 33319
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Lincoln, Rhode Island, 02865
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Little Rock, Arkansas, 72211
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Los Angeles, California, 90048
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Maitland, Florida, 32751
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Memphis, Tennessee, 38119
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Mesa, Arizona, 85210
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Naples, Florida, 34110
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Oak Brook, Illinois, 60523
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Oceanside, California, 92056
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Pembroke Pines, Florida, 33024
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Pismo Beach, California, 93449
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Portland, Oregon, 97210
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Raleigh, North Carolina, 27612
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San Antonio, Texas, 78229
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San Diego, California, 92123
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Santa Rosa, California, 95405
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Springfield, Illinois, 62711
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St. Petersburg, Florida, 33707
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Sterling Heights, Michigan, 48314
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Suwanee, Georgia, 30024
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Tampa, Florida, 33607
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Terre Haute, Indiana, 47802
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The Bronx, New York, 10454
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Torrance, California, 90502
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Wellesley Hills, Massachusetts, 02481
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Winston-Salem, North Carolina, 27103

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About this study

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.

Read the 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.

Conditions: Primary Insomnia, Secondary Insomnia
Being tested: LY2624803, Placebo, zolpidem
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2624803Drug
1 mg, oral capsule, once nightly before bedtime
LY2624803Drug
3 mg, oral capsule, once nightly before bedtime
PlaceboDrug
matching placebo (capsule or tablet), once nightly before bedtime
zolpidemDrug
5 or 10 mg, oral tablet, once nightly before bedtime

Study groups in NCT00784875
Study group	Role	What they receive
Period A	Experimental	2-week double-blind placebo lead-in period. Period A is the first of four 2-week treatment periods. Receives: Drug: Placebo
Period B	Experimental	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. Receives: Drug: LY2624803; Drug: Placebo; Drug: zolpidem
Period C	Experimental	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. Receives: Drug: LY2624803; Drug: Placebo; Drug: zolpidem
Period D	Experimental	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. Receives: Drug: LY2624803; Drug: Placebo; Drug: zolpidem

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Baseline, 2 weeks

Secondary outcomes (24)

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.
Measured: Baseline, 2 weeks
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).
Measured: Baseline, 2 weeks
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).
Measured: Baseline, 2 weeks
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).
Measured: Baseline, 2 weeks
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).
Measured: Baseline, 2 weeks
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).
Measured: Baseline, 2 weeks
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).
Measured: Baseline, 2 weeks
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)
Measured: Baseline, 2 weeks
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).
Measured: Baseline, 2 weeks
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.
Measured: Baseline (Period A) and 2 weeks (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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: Baseline, 2 weeks
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.
Measured: Baseline through 8 weeks
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.
Measured: Baseline, 2 weeks
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.
Measured: Baseline through 8 weeks
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.
Measured: Baseline through 8 weeks
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.
Measured: Baseline through 8 weeks
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.
Measured: Baseline, 2 weeks of treatment over 8 weeks
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.
Measured: Baseline, 2 weeks of treatment over 8 weeks
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.
Measured: Baseline, 2 weeks of treatment over 8 weeks
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).
Measured: 2 weeks of treatment over 8 weeks
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.
Measured: Baseline, 2 weeks of treatment over 8 weeks
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.
Measured: Baseline, 2 weeks of treatment over 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Feb 2010

First posted4 Nov 2008 (estimated)
Study startOct 2008
Primary completionFeb 2010
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Primary InsomniaStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 643 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00784875
Sponsor's protocol ID: 12063
Other IDs: I2K-MC-ZZAD
Acronym: SLUMBER
Status last verified: Jan 2012
First submitted: 31 Oct 2008
Last updated: 29 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Primary Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00784875
Acronym / sponsor ID: SLUMBER / 12063
Conditions: Primary Insomnia, Secondary Insomnia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 643 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 4 Nov 2008 (estimated)
Results: Posted 29 Feb 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Period A	Experimental	Drug: Placebo2-week double-blind placebo lead-in period. Period A is the first of four 2-week treatment periods.
Period B	Experimental	Drug: LY2624803, Drug: Placebo, Drug: zolpidemPatients 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.
Period C	Experimental	Drug: LY2624803, Drug: Placebo, Drug: zolpidemPatients 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.
Period D	Experimental	Drug: LY2624803, Drug: Placebo, Drug: zolpidemPatients 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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY26248031 mg, oral capsule, once nightly before bedtime	Drug	Period B, Period C, Period D
LY26248033 mg, oral capsule, once nightly before bedtime	Drug	Period B, Period C, Period D
Placebomatching placebo (capsule or tablet), once nightly before bedtime	Drug	Period A, Period B, Period C, Period D
zolpidem5 or 10 mg, oral tablet, once nightly before bedtime	Drug	Period B, Period C, Period D

Primary outcome

Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint
Time frame: Baseline, 2 weeks
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).

24 secondary outcomes

Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint
Time frame: Baseline, 2 weeks
Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint
Time frame: Baseline, 2 weeks
Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint
Time frame: Baseline, 2 weeks
Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint
Time frame: Baseline, 2 weeks
Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint
Time frame: Baseline, 2 weeks
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
Time frame: Baseline, 2 weeks
Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint
Time frame: Baseline, 2 weeks
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
Time frame: Baseline, 2 weeks
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
Time frame: Baseline, 2 weeks
Treatment Satisfaction as Measured by the Participant Drug Preference Question
Time frame: Baseline (Period A) and 2 weeks (Period B)
Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
Time frame: 2 weeks
Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
Time frame: 2 weeks
Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Insomnia Type
Time frame: Baseline, 2 weeks
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Insomnia Type
Time frame: Baseline through 8 weeks
Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Age Group
Time frame: Baseline, 2 weeks
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Age Group
Time frame: Baseline through 8 weeks
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Time frame: Baseline through 8 weeks
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Baseline through 8 weeks
Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint
Time frame: Baseline, 2 weeks of treatment over 8 weeks
Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint
Time frame: Baseline, 2 weeks of treatment over 8 weeks
Change From Baseline in Weight at Each 2-week Treatment Endpoint
Time frame: Baseline, 2 weeks of treatment over 8 weeks
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Time frame: 2 weeks of treatment over 8 weeks
Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
Time frame: Baseline, 2 weeks of treatment over 8 weeks
Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
Time frame: Baseline, 2 weeks of treatment over 8 weeks

Results and safety

Results posted to the registry on 29 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY2624803 1 mg	0	0
LY2624803 3 mg	0	0
Zolpidem 5 or 10 mg	0	0
Placebo	643	461

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

Time frame: Baseline, 2 weeks. Least squares mean (Standard Error). Unit: minutes

Measure	LY2624803 1 mg n = 102	LY2624803 3 mg n = 102	Zolpidem 5 or 10 mg n = 102	Placebo n = 101
Value	30.16 (5.300)	37.33 (5.186)	50.63 (5.186)	22.79 (5.153)

Population analysed: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.

24 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events are reported for periods B, C, and D. The number of participants at risk vary depending upon the period in which the AE occurred. Due to discontinuations, later periods had fewer participants.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Period B - LY2624803 1 mg	1 of 114 (0.9%)	28 of 114 (24.6%)	Not reported
Period B - LY2624803 3 mg	1 of 113 (0.9%)	18 of 113 (15.9%)	Not reported
Period B - Placebo	0 of 117 (0%)	21 of 117 (17.9%)	Not reported
Period B - Zolpidem 5 or 10 mg	1 of 117 (0.9%)	33 of 117 (28.2%)	Not reported
Period C - LY2624803 1 mg	0 of 103 (0%)	26 of 103 (25.2%)	Not reported
Period C - LY2624803 3 mg	0 of 97 (0%)	34 of 97 (35.1%)	Not reported
Period C - Placebo	2 of 98 (2%)	22 of 98 (22.4%)	Not reported
Period C - Zolpidem 5 or 10 mg	1 of 97 (1%)	42 of 97 (43.3%)	Not reported
Period D - LY2624803 1 mg	0 of 91 (0%)	29 of 91 (31.9%)	Not reported
Period D - LY2624803 3 mg	0 of 89 (0%)	35 of 89 (39.3%)	Not reported
Period D - Placebo	0 of 88 (0%)	25 of 88 (28.4%)	Not reported
Period D - Zolpidem 5 or 10 mg	0 of 94 (0%)	34 of 94 (36.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

49 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY2624803 and zolpidem in people with Primary Insomnia and Secondary Insomnia, run by Eli Lilly and Company at 49 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint (time frame: Baseline, 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00784875.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2012.