Back to resultsA Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
Primary Purpose
Insomnia
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Eszopiclone 1 mg- Elderly
Eszopiclone 2 mg- Elderly
Eszopiclone 3 mg- Non-elderly
Eszopiclone 2 mg- Non-elderly
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring insomnia, primary insomnia, insomnia associated with psychiatric or physical disorder(s)
Eligibility Criteria
Inclusion criteria:
- Participants who submit written informed consent for study entry.
- Participants aged greater than or equal to 20 and less than 85 years of age at the time of obtaining informed consent.
- 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).
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
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:
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
- Participants with pharmacologically induced insomnia (drug-induced insomnia).
- 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.
- Participants with symptoms that significantly disturb sleep such as pain, fever, diarrhea, frequent micturation, and cough.
- Participants with unstable primary disease presenting insomnia during 4 weeks before the start of observation period.
- Participants with organic mental disorder.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Eszopiclone 1 mg- Elderly
Eszopiclone 2 mg- Elderly
Eszopiclone 2 mg- Non-elderly
Eszopiclone 3 mg- Non-elderly
Arm Description
Outcomes
Primary Outcome Measures
Incidence of Adverse Events
Incidence of adverse events was defined as: (number of participants with adverse events/ number of participants analyzed in the safety analysis set)*100.
An adverse event was defined as any unwanted or untoward disease or its symptom, sign, or abnormality in laboratory parameters in a subject who receives a study drug. An adverse event does not necessarily have a causal relationship with the study drug. The investigator or subinvestigator evaluated adverse events and recorded the results in the case report form (CRF). The investigator or subinvestigator recorded all adverse events occurring after the start of study treatment in the CRF, irrespective of the causal relationship with the study drug or the study procedures. All data collected from the follow-up was recorded in CRF.
Secondary Outcome Measures
Mean Change From Baseline In Sleep Latency
Based on subjective symptoms, the participants recorded their sleep latency (the amount of time measured in minutes it takes to fall asleep) in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the sleep latency of the overall period assessment - sleep latency at baseline (screening period).
Mean Change From Baseline in Wake Time After Sleep Onset (WASO)
Based on subjective symptoms, the participants recorded their WASO defined as total awakening time from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the WASO of the overall period assessment - WASO at baseline (screening period).
Mean Change From Baseline in Total Sleep Time
Based on subjective symptoms, the participants recorded their total sleep time defined as total sleeping time from bedtime to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total sleep time of the overall period assessment - total sleep time at baseline (screening period).
Mean Change From Baseline in Total Number of Awakenings
Based on subjective symptoms, the participants recorded their number of awakenings defined as total number of spontaneous awakenings from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total number of awakenings of the overall period assessment - total number of awakenings at baseline (screening period).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00770692
Brief Title
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
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
insomnia, primary insomnia, insomnia associated with psychiatric or physical disorder(s)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
369 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eszopiclone 1 mg- Elderly
Arm Type
Experimental
Arm Title
Eszopiclone 2 mg- Elderly
Arm Type
Experimental
Arm Title
Eszopiclone 2 mg- Non-elderly
Arm Type
Experimental
Arm Title
Eszopiclone 3 mg- Non-elderly
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Eszopiclone 1 mg- Elderly
Other Intervention Name(s)
SEP-190
Intervention Description
Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
Intervention Type
Drug
Intervention Name(s)
Eszopiclone 2 mg- Elderly
Other Intervention Name(s)
SEP-190
Intervention Description
Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
Intervention Type
Drug
Intervention Name(s)
Eszopiclone 3 mg- Non-elderly
Other Intervention Name(s)
SEP-190
Intervention Description
Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
Intervention Type
Drug
Intervention Name(s)
Eszopiclone 2 mg- Non-elderly
Other Intervention Name(s)
SEP-190
Intervention Description
Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
Primary Outcome Measure Information:
Title
Incidence of Adverse Events
Description
Incidence of adverse events was defined as: (number of participants with adverse events/ number of participants analyzed in the safety analysis set)*100.
An adverse event was defined as any unwanted or untoward disease or its symptom, sign, or abnormality in laboratory parameters in a subject who receives a study drug. An adverse event does not necessarily have a causal relationship with the study drug. The investigator or subinvestigator evaluated adverse events and recorded the results in the case report form (CRF). The investigator or subinvestigator recorded all adverse events occurring after the start of study treatment in the CRF, irrespective of the causal relationship with the study drug or the study procedures. All data collected from the follow-up was recorded in CRF.
Time Frame
Up to 25 weeks (24 weeks treatment period & 1 week follow-up)
Secondary Outcome Measure Information:
Title
Mean Change From Baseline In Sleep Latency
Description
Based on subjective symptoms, the participants recorded their sleep latency (the amount of time measured in minutes it takes to fall asleep) in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the sleep latency of the overall period assessment - sleep latency at baseline (screening period).
Time Frame
Baseline (screening period) and 4 weeks of treatment
Title
Mean Change From Baseline in Wake Time After Sleep Onset (WASO)
Description
Based on subjective symptoms, the participants recorded their WASO defined as total awakening time from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the WASO of the overall period assessment - WASO at baseline (screening period).
Time Frame
Baseline (screening period) and 4 weeks of treatment
Title
Mean Change From Baseline in Total Sleep Time
Description
Based on subjective symptoms, the participants recorded their total sleep time defined as total sleeping time from bedtime to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total sleep time of the overall period assessment - total sleep time at baseline (screening period).
Time Frame
Baseline (screening period) and 4 weeks of treatment
Title
Mean Change From Baseline in Total Number of Awakenings
Description
Based on subjective symptoms, the participants recorded their number of awakenings defined as total number of spontaneous awakenings from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total number of awakenings of the overall period assessment - total number of awakenings at baseline (screening period).
Time Frame
Baseline (screening period) and 4 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Participants who submit written informed consent for study entry.
Participants aged greater than or equal to 20 and less than 85 years of age at the time of obtaining informed consent.
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).
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
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:
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
Participants with pharmacologically induced insomnia (drug-induced insomnia).
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.
Participants with symptoms that significantly disturb sleep such as pain, fever, diarrhea, frequent micturation, and cough.
Participants with unstable primary disease presenting insomnia during 4 weeks before the start of observation period.
Participants with organic mental disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atsushi Kamijo
Organizational Affiliation
New Product Development Department, Clinical Research Center
Official's Role
Study Director
Facility Information:
City
Nagoya
State/Province
Aichi
Country
Japan
City
Iizuka
State/Province
Fukuoka
Country
Japan
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
City
Kurume
State/Province
Fukuoka
Country
Japan
City
Onga
State/Province
Fukuoka
Country
Japan
City
Maebashi
State/Province
Gunma
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Itami
State/Province
Hyogo
Country
Japan
City
Yokohama
State/Province
Kanagawa
Country
Japan
City
Yokoyama
State/Province
Kanagawa
Country
Japan
City
Kashiba
State/Province
Nara
Country
Japan
City
Urazoe
State/Province
Okinawa
Country
Japan
City
Ibaragi
State/Province
Osaka
Country
Japan
City
Kishiwada
State/Province
Osaka
Country
Japan
City
Fujimi
State/Province
Saitama
Country
Japan
City
Kusatsu
State/Province
Shiga
Country
Japan
City
Arakawa-ku
State/Province
Tokyo
Country
Japan
City
Chuo-ku
State/Province
Tokyo
Country
Japan
City
Edogawa-ku
State/Province
Tokyo
Country
Japan
City
Kodaira
State/Province
Tokyo
Country
Japan
City
Koto-ku
State/Province
Tokyo
Country
Japan
City
Minato-ku
State/Province
Tokyo
Country
Japan
City
Musashino
State/Province
Tokyo
Country
Japan
City
Ota-ku
State/Province
Tokyo
Country
Japan
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
City
Toshima-ku
State/Province
Tokyo
Country
Japan
City
Sagamihara
State/Province
Yokohama
Country
Japan
City
Akita
Country
Japan
City
Fukuoka
Country
Japan
City
Kochi
Country
Japan
City
Kumamoto
Country
Japan
City
Kyoto
Country
Japan
City
Osaka
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
22731653
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.
Results Reference
derived
Learn more about this trial
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
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