A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)
Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Insomnia
Intervention: Eszopiclone 1 mg (Drug); Eszopiclone 2 mg (Drug); Eszopiclone 3 mg (Drug); Placebo (Drug); Zolpidem Tartrate 10 mg (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Eisai Co., Ltd. Official(s) and/or principal investigator(s): Atsushi Kamijo, Study Director, Affiliation: New Product Development Department, Clinical Research Center
Summary
The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in
Japanese participants with primary insomnia.
Clinical Details
Official title: A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Latency To Persistent Sleep (LPS)Sleep Latency (SL)
Secondary outcome: Total Sleep Time (Objective & Subjective)Sleep Efficiency Wake Time After Sleep Onset (WASO)- Objective & Subjective Number of Awakenings (Objective & Subjective)
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 treatment period consists of two consecutive days (two nights) as one
term. Patients will receive oral eszopiclone (1, 2, 3 mg), zolpidem tartrate (10 mg), or
placebo once daily at bedtime for each use. Participants were randomly assigned to one of 10
prespecified treatment sequence patterns.
Eligibility
Minimum age: 21 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Participants aged greater than or equal to 21 and less than 65 years at the time of
obtaining written informed consent
2. 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
3. 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:
1. 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.
2. Participants with insomnia caused by pharmacological actions (drug-induced insomnia).
3. Participants with comorbid sleep disorder associated with other disease(s) such as
psychiatric and/or physical disease(s).
4. Participants with a complication of psychiatric disorders in Axis I or personality
disorder in Axis II defined in DSM-IV-TR Japanese version.
5. Participants with organic mental disorder.
Locations and Contacts
Akita, Japan
Fukuoka, Japan
Gifu, Japan
Hiroshima, Japan
Kagoshima, Japan
Kochi, Japan
Kumamoto, Japan
Kyoto, Japan
Osaka, Japan
Toyohashi, Aichi, Japan
Kitakyushu, Fukuoka, Japan
Kurume, Fukuoka, Japan
Otaru, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kawasaki, Kanagawa, Japan
Urazoe, Okinawa, Japan
Sakai, Osaka, Japan
Kodaira, Tokyo, Japan
Setagaya, Tokyo, Japan
Shibuya, Tokyo, Japan
Additional Information
Starting date: September 2008
Last updated: December 28, 2012
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