InsomniaPhase 3NCT00770692
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
A Phase 3 study testing Eszopiclone 1 mg- Elderly, Eszopiclone 2 mg- Elderly and Eszopiclone 3 mg- Non-elderly in people with Insomnia, run by Eisai Co., Ltd. at 34 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 84 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Eszopiclone 1 mg- Elderly, Eszopiclone 2 mg- Elderly and Eszopiclone 3 mg- Non-elderly
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 34 sitesJapan
- Study dates
- Oct 2008to May 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Japan34 sites
Study site
Akita, Akita
Study site
Arakawa-ku, Tokyo
Study site
Chuo-ku, Tokyo
Study site
Edogawa-ku, Tokyo
Study site
Fujimi, Saitama
Study site
Fukuoka, Fukuoka
Study site
Ibaraki, Osaka
Study site
Iizuka, Fukuoka
Study site
Itami, Hyōgo
Study site
Kashiba, Nara
Study site
Kishiwada, Osaka
Study site
Kitakyushu, Fukuoka
Study site
Kochi, Kochi
Study site
Kodaira, Tokyo
Study site
Koga, Fukuoka
Study site
Koto-ku, Tokyo
Study site
Kumamoto, Kumamoto
Study site
Kurume, Fukuoka
Study site
Kusatsu, Shiga
Study site
Kyoto, Kyoto
Study site
Maebashi, Gunma
Study site
Minato-ku, Tokyo
Study site
Musashino, Tokyo
Study site
Nagoya, Aichi-ken
Study site
Osaka, Osaka
Study site
Ōta-ku, Tokyo
Study site
Sagamihara, Yokohama
Study site
Sapporo, Hokkaido
Study site
Shinagawa-ku, Tokyo
Study site
Shinjuku-ku, Tokyo
Study site
Toshima-ku, Tokyo
Study site
Urazoe, Okinawa
Study site
Yokohama, Kanagawa
Study site
Yokoyama, Kanagawa
About this study
Official title: A Phase III Study of SEP-190 (Eszopiclone) in Patients With Insomnia
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- Eszopiclone 1 mg- Elderly, Eszopiclone 2 mg- Elderly, Eszopiclone 3 mg- Non-elderly, Eszopiclone 2 mg- Non-elderly
- Keywords
- insomnia, primary insomnia, insomnia associated with psychiatric or physical disorder(s)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eszopiclone 1 mg- ElderlyDrug
Also called SEP-190
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.
Eszopiclone 2 mg- ElderlyDrug
Also called SEP-190
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.
Eszopiclone 3 mg- Non-elderlyDrug
Also called SEP-190
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.
Eszopiclone 2 mg- Non-elderlyDrug
Also called SEP-190
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.
| Study group | Role | What they receive |
|---|---|---|
| Eszopiclone 1 mg- Elderly | Experimental | Not described Receives: Drug: Eszopiclone 1 mg- Elderly |
| Eszopiclone 2 mg- Elderly | Experimental | Not described Receives: Drug: Eszopiclone 2 mg- Elderly |
| Eszopiclone 2 mg- Non-elderly | Experimental | Not described Receives: Drug: Eszopiclone 2 mg- Non-elderly |
| Eszopiclone 3 mg- Non-elderly | Experimental | Not described Receives: Drug: Eszopiclone 3 mg- Non-elderly |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 25 weeks (24 weeks treatment period & 1 week follow-up)
Secondary outcomes (4)
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).
Measured: Baseline (screening period) and 4 weeks of treatment
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).
Measured: Baseline (screening period) and 4 weeks of treatment
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).
Measured: Baseline (screening period) and 4 weeks of treatment
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).
Measured: Baseline (screening period) and 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Atsushi Kamijo, Study director, New Product Development Department, Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770692
- Sponsor's protocol ID
- 190-150
- Status last verified
- Oct 2012
- First submitted
- 9 Oct 2008
- Last updated
- 22 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 22731653
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of SEP-190 (Eszopiclone) in Patients With Insomnia
- ClinicalTrials.gov ID
- NCT00770692
- Acronym / sponsor ID
- 190-150
- Conditions
- Insomnia
- Keywords
- insomnia, primary insomnia, insomnia associated with psychiatric or physical disorder(s)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 10 Oct 2008 (estimated)
- Results
- Posted 22 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eszopiclone 1 mg- Elderly | Experimental | Drug: Eszopiclone 1 mg- Elderly |
| Eszopiclone 2 mg- Elderly | Experimental | Drug: Eszopiclone 2 mg- Elderly |
| Eszopiclone 2 mg- Non-elderly | Experimental | Drug: Eszopiclone 2 mg- Non-elderly |
| Eszopiclone 3 mg- Non-elderly | Experimental | Drug: Eszopiclone 3 mg- Non-elderly |
Who may qualify
- Ages
- 20 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Participants with data at least 2 consecutive days in diary entries during observation period and confirmed to meet the following two criteria:
Key exclusion criteria (15 listed)
- Participants with a present or history of the following disease specified in
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eszopiclone 1 mg- ElderlyAlso: SEP-190Elderly 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. | Drug | Eszopiclone 1 mg- Elderly |
| Eszopiclone 2 mg- ElderlyAlso: SEP-190Elderly 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. | Drug | Eszopiclone 2 mg- Elderly |
| Eszopiclone 3 mg- Non-elderlyAlso: SEP-190Non-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. | Drug | Eszopiclone 3 mg- Non-elderly |
| Eszopiclone 2 mg- Non-elderlyAlso: SEP-190Non-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. | Drug | Eszopiclone 2 mg- Non-elderly |
Primary outcome
Incidence of Adverse Events
Time frame: Up to 25 weeks (24 weeks treatment period & 1 week follow-up)
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.
4 secondary outcomes
Mean Change From Baseline In Sleep Latency
Time frame: Baseline (screening period) and 4 weeks of treatment
Mean Change From Baseline in Wake Time After Sleep Onset (WASO)
Time frame: Baseline (screening period) and 4 weeks of treatment
Mean Change From Baseline in Total Sleep Time
Time frame: Baseline (screening period) and 4 weeks of treatment
Mean Change From Baseline in Total Number of Awakenings
Time frame: Baseline (screening period) and 4 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22731653Uchimura 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.
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atsushi Kamijo study director
New Product Development Department, Clinical Research Center
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eszopiclone 1 mg- Elderly, Eszopiclone 2 mg- Elderly and Eszopiclone 3 mg- Non-elderly in people with Insomnia, run by Eisai Co., Ltd. at 34 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: Up to 25 weeks (24 weeks treatment period & 1 week follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00770692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2012.