Efficacy Study of LY2422347 to Treat Insomnia
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ClinicalTrials.gov Identifier: NCT00259311 |
Recruitment Status
:
Completed
First Posted
: November 29, 2005
Last Update Posted
: January 26, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Initiation and Maintenance Disorders | Drug: LY2422347 Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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 |
Study Start Date : | November 2005 |
Study Completion Date : | November 2006 |
- The primary efficacy measure will be Wakening After Sleep Onset (WASO)
- 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

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Ages Eligible for Study: | 24 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259311

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 |
ClinicalTrials.gov Identifier: | NCT00259311 History of Changes |
Other Study ID Numbers: |
9951 H9U-MC-MDBD |
First Posted: | November 29, 2005 Key Record Dates |
Last Update Posted: | January 26, 2007 |
Last Verified: | January 2007 |
Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Wake Disorders Nervous System Diseases Mental Disorders |