Efficacy Study of LY2422347 to Treat Insomnia
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00259311
First received: November 28, 2005
Last updated: January 24, 2007
Last verified: January 2007
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Purpose
The purpose of this study is to determine whether a compound known as LY2422347 is effective in treating people diagnosed with primary insomnia (difficulty sleeping with no other significant contributing factor, such as depression).
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Initiation and Maintenance Disorders |
Drug: LY2422347 Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind Comparison of 5 mg of LY2422347, 15 mg of LY2422347, and Placebo in the Treatment of Patients With Primary Insomnia |
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- The primary efficacy measure will be Wakening After Sleep Onset (WASO)
Secondary Outcome Measures:
- Wake Time During Sleep (WTDS) and Wake Time After Sleep (WTAS)
- improvement of daily subjective sleep quality at endpoint
- reduction in the Number of Awakenings or Arousal Index and increase of time spent in Slow Wave Sleep (SWS) and various other parameters at endpoint as measured with PSG
- Various characteristics of sleep and daytime functioning assessed with biweekly self-report questionnaires at endpoint
- increase in subjective sleep efficiency at endpoint as assessed by the patient's daily diary
- Clinician Global Impression of Improvement (CGI-I) score at endpoint
- improvement at endpoint on the biweekly subjective assessment of physical role functioning, emotional role functioning, vitality, social functioning, and mental health using the Short Form-12
- Safety and tolerability of LY2422347 compared with placebo
| Estimated Enrollment: | 400 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | November 2006 |
Eligibility| Ages Eligible for Study: | 24 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- must have been diagnosed with primary insomnia
- must not be significantly overweight
- must be able to visit the study doctor's office once every 2 weeks for 8 weeks and willing to use a handheld electronic device as a sleep diary every day
- must be able to read and speak in English and be able to see well enough to use the handheld electronic device
- the patient's answer to the question "During the past month, how would you rate your sleep quality overall?" must be either "Very Bad" or "Fairly Bad"
Exclusion Criteria:
- cannot have a clinically significant and/or uncontrolled condition or other significant ailment including restless leg syndrome (RLS) or periodic limb movement disorder (PLMD)
- cannot have obstructive sleep apnea (OSA), or be considered by the study doctor to have probable OSA based upon patient history and physical examination
- cannot be currently using antidepressants, antipsychotics, stimulants, antihistaminics, or other medications that are known to effect sleep
- cannot have a current or previous major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder, social anxiety, or another psychotic disorder.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259311
Show 22 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259311
Show 22 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
| ClinicalTrials.gov Identifier: | NCT00259311 History of Changes |
| Other Study ID Numbers: |
9951 H9U-MC-MDBD |
| Study First Received: | November 28, 2005 |
| Last Updated: | January 24, 2007 |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Wake Disorders Nervous System Diseases Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2017