Phase 2
Completed N=643
An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia
Insomnia · Secondary Insomnia
Source: ClinicalTrials.gov NCT00784875 ↗
Enrolled (actual)
643
Serious AEs
0.5%
Results posted
Feb 2012
Primary outcomePrimary: Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint — 30.16; 37.33; 50.63; 22.79 minutes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint |
30.16; 37.33; 50.63; 22.79 | — |
| SECONDARY Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint |
-7.08; -6.45; -20.48; -1.46; -14.84; -12.95 | — |
| SECONDARY Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint |
-0.27; -0.26; -0.59; -0.18 | — |
| SECONDARY Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint |
-28.63; -28.62; -47.28; -13.09 | — |
| SECONDARY Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint |
0.06; 0.06; 0.10; 0.03 | — |
| SECONDARY Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint |
0.17; 0.17; 0.25; 0.13; 0.14; 0.13 | — |
| 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 |
-1.23; -0.87; -1.20; -0.73 | — |
| SECONDARY Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint |
-2.85; -2.83; -4.63; -1.95 | — |
| 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 |
-2.32; -0.28; -0.82; -1.84; 2.49; 1.11 | — |
| 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 |
-3.06; -2.56; -1.71; 0.23 | — |
| SECONDARY Treatment Satisfaction as Measured by the Participant Drug Preference Question |
23.2; 22.9; 12.6; 35.1; 76.8; 77.1 | — |
| SECONDARY Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint |
8.8; 9.8; 15.7; 5.1; 20.6; 23.5 | — |
| SECONDARY Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint |
0; 2.1; 4.2; 3.2; 11.1; 16.7 | — |
| SECONDARY Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Insomnia Type |
— | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Insomnia Type |
— | — |
| SECONDARY Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Age Group |
— | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Age Group |
— | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAE) |
28; 18; 33; 21; 26; 34 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
1; 1; 2; 2 | — |
| SECONDARY Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint |
0.15; 0.21; -0.45; -0.41; 0.83; 0.91 | — |
| SECONDARY Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint |
0.65; 0.95; 0.41; 0.62; 0.42; 0.94 | — |
| SECONDARY Change From Baseline in Weight at Each 2-week Treatment Endpoint |
0.13; 0.27; -0.08; 0.06; 0.03; 0.30 | — |
| SECONDARY Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint |
0; 1; 0; 0; 1; 0 | — |
| SECONDARY Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint |
1.09; 0.26; 1.10; 0.30; -0.59; 0.31 | — |
| SECONDARY Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint |
-0.04; -2.62; -1.02; -1.43; -1.07; -0.41 | — |
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
Data sourced from ClinicalTrials.gov (NCT00784875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.