Efficacy Study of LY2422347 to Treat Insomnia - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00259311

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 II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Genders Eligible for Study:	Both
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

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

Study ID Numbers:	9951, H9U-MC-MDBD
Study First Received:	November 28, 2005
Last Updated:	January 24, 2007
ClinicalTrials.gov Identifier:	NCT00259311
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009