Primary InsomniaPhase 2/3NCT00770510
A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)
A Phase 2/3 study testing Eszopiclone 1 mg, Eszopiclone 2 mg and Eszopiclone 3 mg in people with Primary Insomnia, run by Eisai Co., Ltd. at 20 sites in Japan.
Trial summary
The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- Eszopiclone 1 mg, Eszopiclone 2 mg and Eszopiclone 3 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 20 sitesJapan
- Study dates
- Sep 2008to May 2010
- Phase
- Phase 2/3
- 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 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Study site
Akita, Akita
Study site
Fukuoka, Fukuoka
Study site
Gifu, Gifu
Study site
Hiroshima, Hiroshima
Study site
Kagoshima, Kagoshima-ken
Study site
Kawasaki, Kanagawa
Study site
Kitakyushu, Fukuoka
Study site
Kochi, Kochi
Study site
Kodaira, Tokyo
Study site
Kumamoto, Kumamoto
Study site
Kurume, Fukuoka
Study site
Kyoto, Kyoto
Study site
Osaka, Osaka
Study site
Otaru, Hokkaido
Study site
Sakai, Osaka
Study site
Sapporo, Hokkaido
Study site
Setagaya City, Tokyo
Study site
Shibuya City, Tokyo
Study site
Toyohashi, Aichi-ken
Study site
Urazoe, Okinawa
About this study
Official title: A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia
The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia.
Read the 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.
- Conditions
- Primary Insomnia
- Being tested
- Eszopiclone 1 mg, Eszopiclone 2 mg, Eszopiclone 3 mg, Placebo, Zolpidem Tartrate 10 mg
- Keywords
- Primary insomnia
- 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 mgDrug
Also called SEP-190
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.
Eszopiclone 2 mgDrug
Also called SEP-190
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.
Eszopiclone 3 mgDrug
Also called SEP-190
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.
PlaceboDrug
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.
Zolpidem Tartrate 10 mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Eszopiclone 1 mg | Experimental | Not described Receives: Drug: Eszopiclone 1 mg |
| Eszopiclone 2 mg | Experimental | Not described Receives: Drug: Eszopiclone 2 mg |
| Eszopiclone 3 mg | Experimental | Not described Receives: Drug: Eszopiclone 3 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Zolpidem Tartrate 10 mg | Active comparator | Not described Receives: Drug: Zolpidem Tartrate 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days (5 intervals of two consecutive nights)
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.
Measured: 10 days (5 intervals of two consecutive nights)
Secondary outcomes (4)
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.
Measured: 10 days (5 intervals of two consecutive nights)
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.
Measured: 10 days (5 intervals of two consecutive nights)
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.
Measured: 10 days (5 intervals of two consecutive nights)
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.
Measured: 10 days (5 intervals of two consecutive nights)
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 startSep 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 Primary 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 192 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
- NCT00770510
- Sponsor's protocol ID
- 190-126
- Status last verified
- Dec 2012
- First submitted
- 9 Oct 2008
- Last updated
- 4 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23063301
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia
- ClinicalTrials.gov ID
- NCT00770510
- Acronym / sponsor ID
- 190-126
- Conditions
- Primary Insomnia
- Keywords
- Primary insomnia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 10 Oct 2008 (estimated)
- Results
- Posted 4 Feb 2013
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Eszopiclone 1 mg | Experimental | Drug: Eszopiclone 1 mg |
| Eszopiclone 2 mg | Experimental | Drug: Eszopiclone 2 mg |
| Eszopiclone 3 mg | Experimental | Drug: Eszopiclone 3 mg |
| Placebo | Placebo comparator | Drug: Placebo |
| Zolpidem Tartrate 10 mg | Active comparator | Drug: Zolpidem Tartrate 10 mg |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
- Participants who meet both of the following based on polysomnogram (PSG) in observation period:
Key exclusion criteria (5 listed)
- 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.
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 mgAlso: SEP-190Eszopiclone 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. | Drug | Eszopiclone 1 mg |
| Eszopiclone 2 mgAlso: SEP-190Eszopiclone 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. | Drug | Eszopiclone 2 mg |
| Eszopiclone 3 mgAlso: SEP-190Eszopiclone 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. | Drug | Eszopiclone 3 mg |
| PlaceboPlacebo 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. | Drug | Placebo |
| Zolpidem Tartrate 10 mgZolpidem 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. | Drug | Zolpidem Tartrate 10 mg |
Primary outcome
Latency To Persistent Sleep (LPS)
Time frame: 10 days (5 intervals of two consecutive nights)
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)
Time frame: 10 days (5 intervals of two consecutive nights)
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.
4 secondary outcomes
Total Sleep Time (Objective & Subjective)
Time frame: 10 days (5 intervals of two consecutive nights)
Sleep Efficiency
Time frame: 10 days (5 intervals of two consecutive nights)
Wake Time After Sleep Onset (WASO)- Objective & Subjective
Time frame: 10 days (5 intervals of two consecutive nights)
Number of Awakenings (Objective & Subjective)
Time frame: 10 days (5 intervals of two consecutive nights)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23063301Uchimura 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.
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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
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Eszopiclone 1 mg, Eszopiclone 2 mg and Eszopiclone 3 mg in people with Primary Insomnia, run by Eisai Co., Ltd. at 20 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 7 inclusion and 5 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 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Feb 2013). 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?
Latency To Persistent Sleep (LPS) (time frame: 10 days (5 intervals of two consecutive nights)). The study lists 2 primary outcomes in all. 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 NCT00770510, 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 4 Feb 2013.