Clinical trial NCT00770692: A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
Official title: A Phase III Study of SEP-190 (Eszopiclone) in Patients With Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Keywords: insomnia
primary insomnia
insomnia associated with psychiatric or physical disorder(s)
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-10
Enrollment: 369
Sex: ALL
Minimum age (years): 20
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.

Detailed description: This is a multicenter, randomized, double-blinded study to evaluate the long-term safety of SEP-190 (2, 3 mg) in non-elderly patients with insomnia and SEP-190 (1, 2 mg) in elderly patients with insomnia.

Eligibility criteria: Inclusion criteria:

1. Participants who submit written informed consent for study entry.
2. Participants aged greater than or equal to 20 and less than 85 years of age at the time of obtaining informed consent.
3. Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version or diagnosed with insomnia associated with psychiatric or physical disorder(s).
4. Participants with both of the following conditions which are persistent for 4 weeks or longer before the start of observation period:

   * Total sleep time is less than or equal to 390 minutes for more than or equal to 3 days a week
   * Time to fall asleep taking more than or equal to 30 minutes for more than or equal to 3 days a week
5. Participants with data at least 2 consecutive days in diary entries during observation period and confirmed to meet the following two criteria:

   * Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week
   * Time to fall asleep taking more than or equal to 30 minutes for more than or equal to 3 days a week

Exclusion criteria:

1. Participants with a present or history of the following disease specified in

   Mini-International Neuropsychiatric Interview (M.I.N.I.) Japanese version 5.0:
   * Risk of suicide
   * (Mild) manic episode
   * Post-traumatic stress disorder (PTSD)
   * Alcohol dependence and abuse
   * Drug (non-alcohol) dependence and abuse
   * Anorexia nervosa
   * Bulimia nervosa
   * Anti-social personality disorder
2. Participants with pharmacologically induced insomnia (drug-induced insomnia).
3. Participants with comorbid primary sleep disorders (circadian rhythm disorder, restless legs movement syndrome, periodic limb movement disorder, sleep apnea syndrome, etc.) other than primary insomnia.
4. Participants with symptoms that significantly disturb sleep such as pain, fever, diarrhea, frequent micturation, and cough.
5. Participants with unstable primary disease presenting insomnia during 4 weeks before the start of observation period.
6. Participants with organic mental disorder.

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: Up to 25 weeks (24 weeks treatment period & 1 week follow-up)
Secondary outcomes:
measure: Mean Change From Baseline In Sleep Latency
timeFrame: Baseline (screening period) and 4 weeks of treatment
measure: Mean Change From Baseline in Wake Time After Sleep Onset (WASO)
timeFrame: Baseline (screening period) and 4 weeks of treatment
measure: Mean Change From Baseline in Total Sleep Time
timeFrame: Baseline (screening period) and 4 weeks of treatment
measure: Mean Change From Baseline in Total Number of Awakenings
timeFrame: Baseline (screening period) and 4 weeks of treatment
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Iizuka
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Kurume
country: Japan
state: Fukuoka
city: Onga
country: Japan
state: Fukuoka
city: Maebashi
country: Japan
state: Gunma
city: Sapporo
country: Japan
state: Hokkaido
city: Itami
country: Japan
state: Hyogo
city: Yokohama
country: Japan
state: Kanagawa
city: Yokoyama
country: Japan
state: Kanagawa
city: Kashiba
country: Japan
state: Nara
city: Urazoe
country: Japan
state: Okinawa
city: Ibaragi
country: Japan
state: Osaka
city: Kishiwada
country: Japan
state: Osaka
city: Fujimi
country: Japan
state: Saitama
city: Kusatsu
country: Japan
state: Shiga
city: Arakawa-ku
country: Japan
state: Tokyo
city: Chuo-ku
country: Japan
state: Tokyo
city: Edogawa-ku
country: Japan
state: Tokyo
city: Kodaira
country: Japan
state: Tokyo
city: Koto-ku
country: Japan
state: Tokyo
city: Minato-ku
country: Japan
state: Tokyo
city: Musashino
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Toshima-ku
country: Japan
state: Tokyo
city: Sagamihara
country: Japan
state: Yokohama
city: Akita
country: Japan
city: Fukuoka
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, Takase T. Effects of eszopiclone on safety, subjective measures of efficacy, and quality of life in elderly and nonelderly Japanese patients with chronic insomnia, both with and without comorbid psychiatric disorders: a 24-week, randomized, double-blind study. Ann Gen Psychiatry. 2012 Jun 25;11(1):15. doi: 10.1186/1744-859X-11-15.