InsomniaNCT02455271
Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients
An observational study of Insomnia, run by Eisai Co., Ltd. at 2 sites in Japan.
Trial summary
To investigate the safety and efficacy of administration of eszopiclone for 6 months in insomnia participants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Insomnia
- What is being tested?
- Eszopiclone
- Type of treatment
- Pill or oral medicine
- How many people
- 438 participants
- Where
- 2 sitesJapan
- Study dates
- 1 Oct 2012to 22 Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants who have completed Study LUN01S and need to continue eszopiclone
Who may be able to join
- 1. Participants who have completed LUN01S and need to continue eszopiclone
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients (Study LUN02T)
To investigate the safety and efficacy of administration of eszopiclone for 6 months in insomnia participants.
- Conditions
- Insomnia
- Being tested
- Eszopiclone
- Keywords
- 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.
EszopicloneDrug
Also called EZOP; Lunesta
The usual dosage of eszopiclone is 2 mg per dose for adults and 1 mg per dose for elderly participants, taken orally before bedtime. The dosage may be adjusted according to the participant's symptoms, but a single dose should not exceed 3 mg in adults and 2 mg in elderly participants.
| Study group | Role | What they receive |
|---|---|---|
| Participants with insomnia | Participants with insomnia who will receive eszopiclone per approved label. Receives: Drug: Eszopiclone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of overall improvement
Participants will be interviewed regarding sleep improvement at 3 months after first dose or discontinuation, relative to predose, and select the appropriate answer of: 1. Improved 2. Unchanged 3. Worse 4. Indiscernible
Measured: At month 3
Assessment of overall improvement
Participants will be interviewed regarding sleep improvement at 6 months after first dose or discontinuation, relative to predose, and select the appropriate answer: 1. Improved 2. Unchanged 3. Worse 4. Indiscernible
Measured: At month 6
Secondary outcomes (1)
Number of participants with adverse events (AEs)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study start1 Oct 2012
- Primary completion30 Mar 2015
- Study completion22 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akira Endo, Study director, Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455271
- Sponsor's protocol ID
- LUN02T
- Status last verified
- Jan 2017
- First submitted
- 19 May 2015
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Japanese Journal of Sleep Medicine 11: 81-94, 2017.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients (Study LUN02T)
- ClinicalTrials.gov ID
- NCT02455271
- Acronym / sponsor ID
- LUN02T
- Conditions
- Insomnia
- Keywords
- Insomnia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 30 Mar 2015 (actual)
- Study completion
- 22 Dec 2015 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the safety and efficacy of administration of eszopiclone for 6 months in insomnia participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with insomnia | – | Drug: EszopicloneParticipants with insomnia who will receive eszopiclone per approved label. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who have completed Study LUN01S and need to continue eszopiclone
Key inclusion criteria (1 listed)
- 1. Participants who have completed LUN01S and need to continue eszopiclone
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EszopicloneAlso: EZOP; LunestaThe usual dosage of eszopiclone is 2 mg per dose for adults and 1 mg per dose for elderly participants, taken orally before bedtime. The dosage may be adjusted according to the participant's symptoms, but a single dose should not exceed 3 mg in adults and 2 mg in elderly participants. | Drug | Participants with insomnia |
Primary outcome
Assessment of overall improvement
Time frame: At month 3
Participants will be interviewed regarding sleep improvement at 3 months after first dose or discontinuation, relative to predose, and select the appropriate answer of: 1. Improved 2. Unchanged 3. Worse 4. Indiscernible
Assessment of overall improvement
Time frame: At month 6
Participants will be interviewed regarding sleep improvement at 6 months after first dose or discontinuation, relative to predose, and select the appropriate answer: 1. Improved 2. Unchanged 3. Worse 4. Indiscernible
1 secondary outcome
Number of participants with adverse events (AEs)
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Results publicationJapanese Journal of Sleep Medicine 11: 81-94, 2017.
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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.
Akira Endo study director
Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia, run by Eisai Co., Ltd. at 2 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 1 inclusion and 0 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 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of overall improvement (time frame: At month 3). 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 NCT02455271, 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 7 Sep 2018.