An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia
SLUMBER
A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study of the Safety and Efficacy of LY2624803 in Outpatients With Insomnia
2 other identifiers
interventional
643
1 country
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2008
Shorter than P25 for phase_2
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 31, 2008
CompletedFirst Posted
Study publicly available on registry
November 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
February 29, 2012
CompletedFebruary 29, 2012
January 1, 2012
1.3 years
October 31, 2008
November 17, 2011
January 30, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Baseline, 2 weeks
Secondary Outcomes (24)
Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint
Baseline, 2 weeks
Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint
Baseline, 2 weeks
Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint
Baseline, 2 weeks
Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint
Baseline, 2 weeks
Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint
Baseline, 2 weeks
- +19 more secondary outcomes
Study Arms (4)
Period A
EXPERIMENTAL2-week double-blind placebo lead-in period. Period A is the first of four 2-week treatment periods.
Period B
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Birmingham, Alabama, 35213, United States
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Glendale, Arizona, 85306, United States
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Mesa, Arizona, 85210, United States
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Little Rock, Arkansas, 72211, United States
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Burbank, California, 91505, United States
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Glendale, California, 91206, United States
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Los Angeles, California, 90048, United States
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Oceanside, California, 92056, United States
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Pismo Beach, California, 93449, United States
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San Diego, California, 92123, United States
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Santa Rosa, California, 95405, United States
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Torrance, California, 90502, United States
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Denver, Colorado, 80239, United States
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Fruitland Park, Florida, 34731, United States
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Hialeah, Florida, 33012, United States
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Lauderdale Lakes, Florida, 33319, United States
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Maitland, Florida, 32751, United States
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Naples, Florida, 34110, United States
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Pembroke Pines, Florida, 33024, United States
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St. Petersburg, Florida, 33707, United States
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Tampa, Florida, 33607, United States
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Atlanta, Georgia, 30342, United States
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Suwanee, Georgia, 30024, United States
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Oak Brook, Illinois, 60523, United States
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Springfield, Illinois, 62711, United States
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Terre Haute, Indiana, 47802, United States
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Crestview Hills, Kentucky, 41017, United States
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Chevy Chase, Maryland, 20815, United States
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Wellesley Hills, Massachusetts, 02481, United States
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Sterling Heights, Michigan, 48314, United States
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Florissant, Missouri, 63033, United States
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Las Vegas, Nevada, 89146, United States
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Brooklyn, New York, 11235, United States
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The Bronx, New York, 10454, United States
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Hickory, North Carolina, 28601, United States
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Raleigh, North Carolina, 27612, United States
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Winston-Salem, North Carolina, 27103, United States
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Cincinnati, Ohio, 45246, United States
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Cleveland, Ohio, 44122, United States
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Portland, Oregon, 97210, United States
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Jenkintown, Pennsylvania, 19046, United States
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Lincoln, Rhode Island, 02865, United States
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Anderson, South Carolina, 29621, United States
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Memphis, Tennessee, 38119, United States
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Austin, Texas, 78756, United States
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Dallas, Texas, 75231, United States
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San Antonio, Texas, 78229, United States
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Bellevue, Washington, 98004, United States
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Lakewood, Washington, 98499, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2008
First Posted
November 4, 2008
Study Start
October 1, 2008
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
February 29, 2012
Results First Posted
February 29, 2012
Record last verified: 2012-01