Chronic InsomniaPhase 3NCT06512363
A Study of Ramelteon in Chinese Patients With Chronic Insomnia
A Phase 3 study testing Ramelteon in people with Chronic Insomnia, run by Nanjing Chia-tai Tianqing Pharmaceutical.
Trial summary
The purpose of this study is to assess the efficacy and safety of Ramelteon in chinese patients with chronic insomnia. Efficacy will be evaluated on objective and subjective sleep parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Ramelteon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 18 years old.
- Chronic insomnia disorder diagnosed according to International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) criteria.
- Self-reported history of all the following on at least 3 nights per week within 4 weeks prior to screening: subjective sleep latency (sSL) greater than or equal to 30 minutes, and subjective total sleep time (sTST) less than or equal to 6.5 hours per night.
- Meeting all the following sleep parameters on the 2 PSG nights during the run-in period: mean latency to persistent sleep (LPS) ≥ 20 min (with neither of the two nights < 15 min), and mean wake after sleep onset (WASO) ≥ 30 min (with neither of the two nights < 20 min).
- Usual bedtime between 20:30 and 01:00, and regular time in bed between 6.5 and 9 h.
- Insomnia Severity Index score≥15 at screening and on Day 1 of the treatment period.
- Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent.
Who cannot join
- Use of ramelteon within 30 days prior to screening.
- Previous non-responders to melatonin receptor agonist therapy.
- Known hypersensitivity to ramelteon or related compounds, including melatonin.
- Sleep schedule changes required by employment (e.g. shift worker), or has flown across greater than three time zones (mainland China is considered as 1 time zone) within 30 days prior to screening and during the study period; or special professionals who need to operate machinery during the study period, such as professional drivers, high-altitude operators, etc.
- Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to screening and during the study period.
- Previous history of nervous system disorders such as epilepsy, schizophrenia, bipolar mental disorder, neurodevelopmental retardation, and cognitive disorder, or previous history of other mental illness that may affect the safety of the subjects or interfere with the study assessments in the opinion of the investigator.
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- Previous history of other sleep disorders secondary to other diseases including moderate to severe obstructive sleep apne, circadian rhythm sleep disturbances, paroxysmal sleeping sickness, and restless legs syndrome.
- Apnea-hypopnea index (AHI) and periodic limb movement index (PLMI) > 15 times/hour detected by PSG monitoring during the run-in period.
- Have previous complex sleep behaviors, such as sleep driving, sleep eating, and sleep phone calls.
- Hamilton Anxiety Scale (HAMA) score ≥ 14 and Hamilton Depression Scale (HAMD) score ≥ 18 at screening.
- Have serious diseases of cardiovascular system, digestive system, respiratory system, urinary system, endocrine system, immune system, etc., which are not suitable for the study judged by the investigators.
- AST or ALT > 3 × ULN, and TBIL > 2 × ULN.
- Patients with HIV or syphilis infection.
- Use of any hypnotics, antidepressants, antipsychotic drugs, anticholinergics, memory-enhancing drugs, antihistamines, centrally acting analgesics, centrally acting muscle relaxants, central nervous system stimulants, strong CYP1A2 inhibitors, strong CYP2C9 inhibitors, strong CYP3A4 inhibitors, strong CYP inducers, or any other therapies for insomnia disorder within 1 week prior to the run-in period or within 5 half-lives of the investigational product, whichever is longer.
- Requirement of taking any prohibited medication during study period.
- History of drug abuse within 1 year prior to screening, or positive urine drug screening.
- History of alcohol abuse within 1 year prior to screening, or unwilling to follow alcohol restriction during the study period.
- Regular daily consumption of excessive tea and coffee drinks, or unwilling to follow tea/coffee restriction during the study period.
- History of smoking addiction or unwilling to follow tobacco restriction during the study period.
- Participated in any other investigational study and taken any investigational drug within 1 month or 5 half-lives prior to screening, whichever is longer.
- Pregnant or lactating women, or planning to have children or both men of reproductive potential and women of childbearing potential disagree to use ≥1 effective contraception throughout the study and within 3 months after the end of the study.
- MEQ-19 score ≤ 49.
- Other conditions that are not considered appropriate by the investigator.
About this study
Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Ramelteon in Chinese Patients With Chronic Insomnia
The purpose of this study is to assess the efficacy and safety of Ramelteon in chinese patients with chronic insomnia.
Efficacy will be evaluated on objective and subjective sleep parameters.
- Conditions
- Chronic Insomnia
- Being tested
- Ramelteon, Ramelteon placebo
- 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.
RamelteonDrug
Ramelteon 8 mg, tablets, orally, once nightly for up to 5 weeks.
Ramelteon placeboDrug
Ramelteon placebo-matching tablets, orally, once nightly for up to 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ramelteon 8 mg QN | Experimental | Not described Receives: Drug: Ramelteon |
| Placebo | Placebo comparator | Not described Receives: Drug: Ramelteon placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Latency to Persistent Sleep Assessed by Polysomnography
Measured: Week 1
Secondary outcomes (12)
Mean Latency to Persistent Sleep Assessed by Polysomnography
Measured: Week 5
Total Sleep Time Assessed by Polysomnography
Measured: Weeks 1 and 5
Sleep Efficiency Assessed by Polysomnography
Measured: Weeks 1 and 5
Awake Time after Persistent Sleep Assessed by Polysomnography
Measured: Weeks 1 and 5
Number of Awakenings after Persistent Sleep Assessed by Polysomnography
Measured: Weeks 1 and 5
Subjective Sleep Latency Assessed by Sleep Diary Questionnaire
Measured: Weeks 1, 3 and 5
Subjective Total Sleep Time Assessed by Sleep Diary Questionnaire
Measured: Weeks 1, 3 and 5
Subjective Sleep Quality Assessed by Sleep Diary Questionnaire
Measured: Weeks 1, 3 and 5
Subjective Awake Time Assessed by Sleep Diary Questionnaire
Measured: Weeks 1, 3 and 5
Subjective Number of Awakenings Assessed by Sleep Diary Questionnaire
Measured: Weeks 1, 3 and 5
Subjective Ease of Falling Back to Sleep Assessed by Sleep Diary Questionnaire
Measured: Weeks 1, 3 and 5
Insomnia Severity Index Score Assessed by ISI Questionnaire
Measured: Weeks 3 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- More trials run by Nanjing Chia-tai Tianqing PharmaceuticalThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512363
- Sponsor's protocol ID
- LMTAP2022-III
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Ramelteon in Chinese Patients With Chronic Insomnia
- ClinicalTrials.gov ID
- NCT06512363
- Acronym / sponsor ID
- LMTAP2022-III
- Conditions
- Chronic Insomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Nanjing Chia-tai Tianqing PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jul 2024 (actual)
- 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.
The purpose of this study is to assess the efficacy and safety of Ramelteon in chinese patients with chronic insomnia.
Efficacy will be evaluated on objective and subjective sleep parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ramelteon 8 mg QN | Experimental | Drug: Ramelteon |
| Placebo | Placebo comparator | Drug: Ramelteon placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged ≥ 18 years old.
- Chronic insomnia disorder diagnosed according to International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) criteria.
- Self-reported history of all the following on at least 3 nights per week within 4 weeks prior to screening: subjective sleep latency (sSL) greater than or equal to 30 minutes, and subjective total sleep time (sTST) less than or equal to 6.5 hours per night.
- Meeting all the following sleep parameters on the 2 PSG nights during the run-in period: mean latency to persistent sleep (LPS) ≥ 20 min (with neither of the two nights < 15 min), and mean wake after sleep onset (WASO) ≥ 30 min (with neither of the two nights < 20 min).
- Usual bedtime between 20:30 and 01:00, and regular time in bed between 6.5 and 9 h.
Key exclusion criteria (23 listed)
- Use of ramelteon within 30 days prior to screening.
- Previous non-responders to melatonin receptor agonist therapy.
- Known hypersensitivity to ramelteon or related compounds, including melatonin.
- Sleep schedule changes required by employment (e.g. shift worker), or has flown across greater than three time zones (mainland China is considered as 1 time zone) within 30 days prior to screening and during the study period; or special professionals who need to operate machinery during the study period, such as professional drivers, high-altitude operators, etc.
- Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to screening and during the study 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 |
|---|---|---|
| RamelteonRamelteon 8 mg, tablets, orally, once nightly for up to 5 weeks. | Drug | Ramelteon 8 mg QN |
| Ramelteon placeboRamelteon placebo-matching tablets, orally, once nightly for up to 5 weeks. | Drug | Placebo |
Primary outcome
Mean Latency to Persistent Sleep Assessed by Polysomnography
Time frame: Week 1
12 secondary outcomes
Mean Latency to Persistent Sleep Assessed by Polysomnography
Time frame: Week 5
Total Sleep Time Assessed by Polysomnography
Time frame: Weeks 1 and 5
Sleep Efficiency Assessed by Polysomnography
Time frame: Weeks 1 and 5
Awake Time after Persistent Sleep Assessed by Polysomnography
Time frame: Weeks 1 and 5
Number of Awakenings after Persistent Sleep Assessed by Polysomnography
Time frame: Weeks 1 and 5
Subjective Sleep Latency Assessed by Sleep Diary Questionnaire
Time frame: Weeks 1, 3 and 5
Subjective Total Sleep Time Assessed by Sleep Diary Questionnaire
Time frame: Weeks 1, 3 and 5
Subjective Sleep Quality Assessed by Sleep Diary Questionnaire
Time frame: Weeks 1, 3 and 5
Subjective Awake Time Assessed by Sleep Diary Questionnaire
Time frame: Weeks 1, 3 and 5
Subjective Number of Awakenings Assessed by Sleep Diary Questionnaire
Time frame: Weeks 1, 3 and 5
Subjective Ease of Falling Back to Sleep Assessed by Sleep Diary Questionnaire
Time frame: Weeks 1, 3 and 5
Insomnia Severity Index Score Assessed by ISI Questionnaire
Time frame: Weeks 3 and 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ramelteon in people with Chronic Insomnia, run by Nanjing Chia-tai Tianqing Pharmaceutical.
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 23 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: opening soon, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 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?
This study is still under way. Results are not available in the source record yet.
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?
Mean Latency to Persistent Sleep Assessed by Polysomnography (time frame: Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2024.