Status:
COMPLETED
A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Primary Insomnia
Eligibility:
All Genders
21-64 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia.
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled, 5-way cross-over study to investigate and evaluate the efficacy of eszopiclone in Japanese participants with primary insomnia. The ...
Eligibility Criteria
Inclusion
- Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent
- Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version and have both of the following conditions which are persistent for more than or equal to 4 weeks before the start of observation period:
- Sleep latency of more than or equal to 30 minutes for more than or equal to 3 days a week
- Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week
- Participants who meet both of the following based on polysomnogram (PSG) in observation period:
- Objective sleep latency of more than or equal to 20 minutes for 2 consecutive PSG days
- Objective total sleep time of less than or equal to 420 minutes for 2 consecutive PSG days, or objective wake time during sleep of more than or equal to 20 minutes for 2 consecutive PSG days
Exclusion
- Participants with comorbid primary sleep disorders (e.g., circadian rhythm disorder, restless limb syndrome, periodic limb movement disorder, sleep apnea syndrome), other than primary insomnia.
- Participants with insomnia caused by pharmacological actions (drug-induced insomnia).
- Participants with comorbid sleep disorder associated with other disease(s) such as psychiatric and/or physical disease(s).
- Participants with a complication of psychiatric disorders in Axis I or personality disorder in Axis II defined in DSM-IV-TR Japanese version.
- Participants with organic mental disorder.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT00770510
Start Date
September 1 2008
End Date
May 1 2010
Last Update
February 4 2013
Active Locations (20)
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1
Toyohashi, Aichi-ken, Japan
2
Akita, Akita, Japan
3
Fukuoka, Fukuoka, Japan
4
Kitakyushu, Fukuoka, Japan