Clinical trial NCT00770510: A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)
Official title: A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Primary Insomnia
Keywords: Primary insomnia
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-10
Enrollment: 192
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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 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.

Primary outcomes:
measure: Latency To Persistent Sleep (LPS)
timeFrame: 10 days (5 intervals of two consecutive nights)
measure: Sleep Latency (SL)
timeFrame: 10 days (5 intervals of two consecutive nights)
Secondary outcomes:
measure: Total Sleep Time (Objective & Subjective)
timeFrame: 10 days (5 intervals of two consecutive nights)
measure: Sleep Efficiency
timeFrame: 10 days (5 intervals of two consecutive nights)
measure: Wake Time After Sleep Onset (WASO)- Objective & Subjective
timeFrame: 10 days (5 intervals of two consecutive nights)
measure: Number of Awakenings (Objective & Subjective)
timeFrame: 10 days (5 intervals of two consecutive nights)
Other outcomes:
Locations:
city: Toyohashi
country: Japan
state: Aichi
city: Kitakyushu
country: Japan
state: Fukuoka
city: Kurume
country: Japan
state: Fukuoka
city: Otaru
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Kawasaki
country: Japan
state: Kanagawa
city: Urazoe
country: Japan
state: Okinawa
city: Sakai
country: Japan
state: Osaka
city: Kodaira
country: Japan
state: Tokyo
city: Setagaya
country: Japan
state: Tokyo
city: Shibuya
country: Japan
state: Tokyo
city: Akita
country: Japan
city: Fukuoka
country: Japan
city: Gifu
country: Japan
city: Hiroshima
country: Japan
city: Kagoshima
country: Japan
city: Kochi
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Osaka
country: Japan
Study officials:
affiliation: New Product Development Department, Clinical Research Center
name: Atsushi Kamijo
role: STUDY_DIRECTOR
References:
citation: Uchimura N, Kamijo A, Kuwahara H, Uchiyama M, Shimizu T, Chiba S, Inoue Y. A randomized placebo-controlled polysomnographic study of eszopiclone in Japanese patients with primary insomnia. Sleep Med. 2012 Dec;13(10):1247-53. doi: 10.1016/j.sleep.2012.08.015. Epub 2012 Oct 11.