Back to resultsA Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)
Primary Purpose
Primary Insomnia
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Eszopiclone 1 mg
Eszopiclone 2 mg
Eszopiclone 3 mg
Placebo
Zolpidem Tartrate 10 mg
Sponsored by
About this trial
This is an interventional treatment trial for Primary Insomnia focused on measuring 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
Eszopiclone 1 mg
Eszopiclone 2 mg
Eszopiclone 3 mg
Placebo
Zolpidem Tartrate 10 mg
Arm Description
Outcomes
Primary Outcome Measures
Latency To Persistent Sleep (LPS)
The objective measure, LPS, defined as the amount of time measured in minutes it takes to fall asleep was based on polysomnography (PSG) objective assessments of sleep disturbance. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
Sleep Latency (SL)
The subjective measure, SL, defined as the amount of time measured in minutes it takes to fall asleep was based on participant-reported subjective assessments of sleep disturbance and was obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.
Secondary Outcome Measures
Total Sleep Time (Objective & Subjective)
Total sleep time defined as total sleeping time from bedtime to final awakening (measured in minutes) was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.
The objective total sleep time was based on PSG-based assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
The subjective measure was based on participant-reported subjective assessments of sleep disturbance and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.
Sleep Efficiency
Sleep efficiency (SE) was an assessment obtained from PSG during the treatment period and was defined as the ratio of total sleep time to the total time in bed of 8 hours * 100, expressed as a percent.
PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the patient's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
Wake Time After Sleep Onset (WASO)- Objective & Subjective
Wake Time After Sleep Onset (WASO) defined as total awakening time from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.
The objective WASO was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.
Number of Awakenings (Objective & Subjective)
Number of awakenings defined as the total number of spontaneous awakenings from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.
The objective number of awakenings was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00770510
Brief Title
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
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
Keywords
Primary insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eszopiclone 1 mg
Arm Type
Experimental
Arm Title
Eszopiclone 2 mg
Arm Type
Experimental
Arm Title
Eszopiclone 3 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Zolpidem Tartrate 10 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Eszopiclone 1 mg
Other Intervention Name(s)
SEP-190
Intervention Description
Eszopiclone 1 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.
Intervention Type
Drug
Intervention Name(s)
Eszopiclone 2 mg
Other Intervention Name(s)
SEP-190
Intervention Description
Eszopiclone 2 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.
Intervention Type
Drug
Intervention Name(s)
Eszopiclone 3 mg
Other Intervention Name(s)
SEP-190
Intervention Description
Eszopiclone 3 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.
Intervention Type
Drug
Intervention Name(s)
Zolpidem Tartrate 10 mg
Intervention Description
Zolpidem Tartrate 10 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.
Primary Outcome Measure Information:
Title
Latency To Persistent Sleep (LPS)
Description
The objective measure, LPS, defined as the amount of time measured in minutes it takes to fall asleep was based on polysomnography (PSG) objective assessments of sleep disturbance. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
Time Frame
10 days (5 intervals of two consecutive nights)
Title
Sleep Latency (SL)
Description
The subjective measure, SL, defined as the amount of time measured in minutes it takes to fall asleep was based on participant-reported subjective assessments of sleep disturbance and was obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.
Time Frame
10 days (5 intervals of two consecutive nights)
Secondary Outcome Measure Information:
Title
Total Sleep Time (Objective & Subjective)
Description
Total sleep time defined as total sleeping time from bedtime to final awakening (measured in minutes) was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.
The objective total sleep time was based on PSG-based assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
The subjective measure was based on participant-reported subjective assessments of sleep disturbance and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.
Time Frame
10 days (5 intervals of two consecutive nights)
Title
Sleep Efficiency
Description
Sleep efficiency (SE) was an assessment obtained from PSG during the treatment period and was defined as the ratio of total sleep time to the total time in bed of 8 hours * 100, expressed as a percent.
PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the patient's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
Time Frame
10 days (5 intervals of two consecutive nights)
Title
Wake Time After Sleep Onset (WASO)- Objective & Subjective
Description
Wake Time After Sleep Onset (WASO) defined as total awakening time from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.
The objective WASO was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.
Time Frame
10 days (5 intervals of two consecutive nights)
Title
Number of Awakenings (Objective & Subjective)
Description
Number of awakenings defined as the total number of spontaneous awakenings from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.
The objective number of awakenings was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.
The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.
Time Frame
10 days (5 intervals of two consecutive nights)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
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
Toyohashi
State/Province
Aichi
Country
Japan
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
City
Kurume
State/Province
Fukuoka
Country
Japan
City
Otaru
State/Province
Hokkaido
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Kawasaki
State/Province
Kanagawa
Country
Japan
City
Urazoe
State/Province
Okinawa
Country
Japan
City
Sakai
State/Province
Osaka
Country
Japan
City
Kodaira
State/Province
Tokyo
Country
Japan
City
Setagaya
State/Province
Tokyo
Country
Japan
City
Shibuya
State/Province
Tokyo
Country
Japan
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
23063301
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.
Results Reference
derived
Learn more about this trial
A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)
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