Phase 3 N=72 Randomized Double-blind Treatment

A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)

Primary Insomnia

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View on ClinicalTrials.gov: NCT00770510 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2013

Primary outcome: Primary: Latency To Persistent Sleep (LPS) — 37.5; 24.4; 20.9; 12.8 Minutes

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Eszopiclone 1 mg (Drug); Eszopiclone 2 mg (Drug); Eszopiclone 3 mg (Drug); Placebo (Drug); Zolpidem Tartrate 10 mg (Drug)
Age: Adult · 21+ yrs
Sex: All
Sponsor: Eisai Co., Ltd.
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Latency To Persistent Sleep (LPS)	37.5; 24.4; 20.9; 12.8; 14.3	—
PRIMARY Sleep Latency (SL)	62.0; 45.5; 32.6; 28.4; 28.0	—
SECONDARY Total Sleep Time (Objective & Subjective)	414.0; 438.3; 452.5; 453.4; 448.6; 360.0	—
SECONDARY Sleep Efficiency	86.3; 91.3; 94.3; 94.5; 93.5	—
SECONDARY Wake Time After Sleep Onset (WASO)- Objective & Subjective	26.3; 22.5; 17.8; 18.8; 20.0; 75.0	—
SECONDARY Number of Awakenings (Objective & Subjective)	4.0; 4.0; 3.5; 2.8; 3.5; 3.0	—

Summary

The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT00770510). 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.