Insomnia DisordersPhase 4EASY-TIPNCT07733414
Evaluating the Efficacy and Safety of Daridorexant Transition From BZRAs in Insomnia Patients（EASY-TIP）
A Phase 4 study testing Daridorexant in people with Insomnia Disorders, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Brief Summary: This study is a prospective, multicenter, open-label cohort study designed to evaluate the efficacy and safety of transitioning adult patients with insomnia from benzodiazepine receptor agonists (BZRAs) to daridorexant. A total of 156 participants will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Insomnia Disorders
- What is being tested?
- Daridorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 1 Dec 2030
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged ≥18 and ≤70 years.
- Meet DSM-5 diagnostic criteria for insomnia disorder: dissatisfaction with nighttime sleep despite adequate sleep opportunity, manifested as difficulty initiating sleep, difficulty maintaining sleep (frequent awakenings or difficulty returning to sleep after awakening), or early-morning awakening with inability to resume sleep, accompanied by subjective experience of daytime dysfunction. Symptoms occur ≥3 times per week and persist for ≥3 months.
- Received stable BZRA monotherapy for at least 3 nights per week during the 1 month prior to enrollment.
- Bedtime duration of no less than 7 hours per night.
- Unsatisfactory response or intolerance to current therapy, with clinical need to adjust insomnia medication regimen.
- Hamilton Anxiety Rating Scale (HAMA-14) score <14.
- Hamilton Depression Rating Scale (HAMD-17) score <17.
- Willing and able to comply with the study protocol and provide written informed consent.
Who cannot join
- History of chronic insomnia >5 years.
- Other sleep disorders such as narcolepsy-related symptoms, restless legs syndrome, circadian rhythm sleep disorder, REM sleep behavior disorder, etc.
- Daytime napping ≥1 hour/day and ≥3 days/week.
- Daily BZRA dose exceeding the maximum recommended dose for insomnia treatment per package insert.
- BZRA use >5 nights per week.
- History of BZRA treatment ≥3 years.
Show all 20Show fewer
- Concurrent use of two or more BZRAs within the past 3 months.
- Use of central nervous system depressants within the past 3 months.
- Use of long-acting sedative-hypnotics (e.g., clonazepam) within the past 3 months.
- Use of anxiolytics or antidepressants for off-label insomnia treatment within the past 3 months.
- Initiation of cognitive behavioral therapy for insomnia (CBT-I) within 1 month prior to Visit 1.
- Prior non-response to orexin receptor antagonists (daridorexant, lemborexant, suvorexant, etc.).
- Clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal) that may affect participant safety or interfere with study assessments, as judged by the investigator. Participants for whom sedative medications are contraindicated due to occupational or safety reasons are also excluded.
- Severe psychiatric disorder within the past 6 months, or severe alcohol/substance abuse/dependence within the past 2 years.
- Active suicidal ideation or behavior within the past 6 months.
- Pregnancy, lactation, or planned pregnancy within 90 days.
- Unable to avoid excessive alcohol consumption during the study.
- History of hypersensitivity to any component of daridorexant tablets.
- Severe hepatic impairment (Child-Pugh score ≥10).
- Unable to discontinue strong CYP3A4 inhibitors and strong or moderate CYP3A4 inducers during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 10053
Shuqin Zhan, +86 10 83198277, shqzhan@hotmail.com
Shuqin Zhan
About this study
Brief Summary:
This study is a prospective, multicenter, open-label cohort study designed to evaluate the efficacy and safety of transitioning adult patients with insomnia from benzodiazepine receptor agonists (BZRAs) to daridorexant.
Read more
A total of 156 participants will be enrolled. The study consists of a 1-week baseline phase and a 9-week daridorexant treatment phase. During the treatment phase, daridorexant 50 mg is initiated once daily while BZRAs are gradually tapered and discontinued based on individual patient response.
The primary outcome is the proportion of patients who successfully transition from BZRAs to daridorexant at Week 5, defined as a ≥50% reduction or complete discontinuation of the original BZRA dose, with continued willingness to take daridorexant and no withdrawal due to worsening insomnia or adverse events. Secondary outcomes include changes in Insomnia Severity Index (ISI) scores and patient-reported sleep outcomes.
This study aims to provide real-world evidence for the safe and effective transition from BZRAs to daridorexant in clinical practice.
Read the detailed description
Detailed Description:
Background: Insomnia is a prevalent disorder that significantly impacts quality of life and daytime functioning. Benzodiazepine receptor agonists (BZRAs), including benzodiazepines and non-benzodiazepines, are commonly used but are associated with tolerance, dependence, withdrawal symptoms, and disruption of sleep architecture. Daridorexant, a dual orexin receptor antagonist (DORA), offers a novel mechanism by reducing hyperarousal and promoting physiological sleep, with a favorable safety profile and no withdrawal effects upon discontinuation. However, real-world evidence on transitioning patients from BZRAs to daridorexant remains limited.
Study Objective: To evaluate the efficacy and safety of transitioning adult insomnia patients from BZRAs to daridorexant in a clinical practice setting.
Study Design: This is a prospective, multicenter, open-label, cohort study. Patients will be enrolled across multiple sites in China. The study consists of two phases: a 1-week baseline phase (during which patients continue their usual BZRA therapy) and a 9-week daridorexant treatment phase. During the treatment phase, daridorexant 50 mg is initiated once daily, 30 minutes before bedtime, while the original BZRA is tapered and discontinued according to individual patient response, following a cross-tapering approach.
Population: A total of 156 adult patients (aged 18-70 years) with insomnia disorder according to DSM-5 criteria, who have been on stable BZRA monotherapy for at least 3 nights per week for the past month, and who are dissatisfied with or intolerant to their current therapy, will be enrolled. Key exclusion criteria include chronic insomnia >5 years, severe psychiatric disorders, significant comorbidities, and prior use of DORA agents without response.
Intervention: Daridorexant tablets (50 mg) taken orally once nightly. Dose adjustment to 25 mg is permitted based on tolerability, but the maximum dose is 50 mg daily.
Outcomes:
Primary Outcome: The proportion of patients who successfully transition from BZRAs to daridorexant at Week 5, defined as a ≥50% reduction or complete discontinuation of the original BZRA dose, with continued willingness to take daridorexant, and no withdrawal due to worsening insomnia or adverse events.
Secondary Outcomes: Changes from baseline in Insomnia Severity Index (ISI) scores; patient-reported sleep outcomes (subjective total sleep time, sleep quality) assessed by electronic sleep diary; and patterns of daridorexant and BZRA dosing adjustments.
Safety Outcomes: Incidence and severity of treatment-emergent adverse events (TEAEs); assessment of benzodiazepine withdrawal symptoms using the Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ).
Visit Schedule: Patients will undergo 6 visits: at Day 0 (V1, screening), Day 7 (V2, baseline, daridorexant initiation), Day 14 (V3), Day 21 (V4), Day 42 (V5, primary endpoint), and Day 70 (V6, end of treatment). Assessments include ISI, electronic sleep diary, BWSQ, and safety monitoring at each visit.
Sample Size: Based on an expected transition success rate of 80% at Week 5, with a 95% confidence interval and 10% margin of error, and accounting for a 10% dropout rate, a total of 156 patients will be enrolled (78 per BZRA subgroup).
Statistical Analysis: The primary analysis will be performed on the full analysis set (FAS). Descriptive statistics will be used for baseline characteristics. The primary endpoint will be presented with a 95% confidence interval. Secondary endpoints will be analyzed using appropriate parametric or non-parametric methods. Safety data will be summarized descriptively.
Ethical Considerations: The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. The protocol has been approved by the Ethics Committee of Xuanwu Hospital, Capital Medical University. Written informed consent will be obtained from all participants.
Expected Impact: This study aims to provide real-world evidence on the safe and effective transition from BZRAs to daridorexant, informing clinical decision-making and potentially improving long-term insomnia management in Chinese patients.
- Conditions
- Insomnia Disorders
- Being tested
- Daridorexant
- Keywords
- Insomnia Disorder, Daridorexant, BZRAs, Drug Transition
- 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.
DaridorexantDrug
Also called Quviciq
Daridorexant is a dual orexin receptor antagonist (DORA) supplied as 50 mg film-coated tablets for oral administration. Participants receive 50 mg once nightly, 30 minutes before bedtime, for up to 9 weeks. Dose reduction to 25 mg is permitted based on tolerability. The drug is provided by Jiangsu Simcere Pharmaceutical Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| Daridorexant Transition Group | Experimental | Participants receive daridorexant 50 mg orally once nightly for 9 weeks, with gradual tapering and discontinuation of their prior benzodiazepine receptor agonist (BZRA) therapy based on individual clinical response. Dose reduction of daridorexant to 25 mg is permitted if clinically indicated. The study includes 6 visits over 10 weeks, with the primary endpoint assessed at Week 5. Receives: Drug: Daridorexant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Successfully Transitioning from BZRAs to Daridorexant at Week 5
Defined as a ≥50% reduction or complete discontinuation of the original BZRA dose, with continued willingness to take daridorexant, and no withdrawal due to worsening insomnia or adverse events at Week 5 (Visit 5, Day 42 ± 3 days).
Measured: At Week 5 (Visit 5, Day 42 ± 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insomnia DisordersStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhan, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733414
- Sponsor's protocol ID
- CNS-DARI-IS_002
- Acronym
- EASY-TIP
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not currently have a formal plan to share individual participant data (IPD). Any future data sharing will be considered on a case-by-case basis and will require approval from the Principal Investigator and the relevant Institutional Review Board (IRB), as well as execution of a data use agreement.
Publications
Roch C, Bergamini G, Steiner MA, Clozel M. Nonclinical pharmacology of daridorexant: a new dual orexin receptor antagonist for the treatment of insomnia. Psychopharmacology (Berl). 2021 Oct;238(10):2693-2708. doi: 10.1007/s00213-021-05954-0. Epub 2021 Aug 20.
PubMed 34415378Treiber A, de Kanter R, Roch C, Gatfield J, Boss C, von Raumer M, Schindelholz B, Muehlan C, van Gerven J, Jenck F. The Use of Physiology-Based Pharmacokinetic and Pharmacodynamic Modeling in the Discovery of the Dual Orexin Receptor Antagonist ACT-541468. J Pharmacol Exp Ther. 2017 Sep;362(3):489-503. doi: 10.1124/jpet.117.241596. Epub 2017 Jun 29.
PubMed 28663311
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of Daridorexant Transition From BZRAs in Insomnia Patients（EASY-TIP）
- ClinicalTrials.gov ID
- NCT07733414
- Acronym / sponsor ID
- EASY-TIP / CNS-DARI-IS_002
- Conditions
- Insomnia Disorders
- Keywords
- Insomnia Disorder, Daridorexant, BZRAs, Drug Transition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 29 Jul 2026 (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.
Brief Summary:
This study is a prospective, multicenter, open-label cohort study designed to evaluate the efficacy and safety of transitioning adult patients with insomnia from benzodiazepine receptor agonists (BZRAs) to daridorexant.
A total of 156 participants will be enrolled. The study consists of a 1-week baseline phase and a 9-week daridorexant treatment phase. During the treatment phase, daridorexant 50 mg is initiated once daily while BZRAs are gradually tapered and discontinued based on individual patient response.
The primary outcome is the proportion of patients who successfully transition from BZRAs to daridorexant at Week 5, defined as a ≥50% reduction or complete discontinuation of the original BZRA dose, with continued willingness to take daridorexant and no withdrawal due to worsening insomnia or adverse events. Secondary outcomes include changes in Insomnia Severity Index (ISI) scores and patient-reported sleep outcomes.
This study aims to provide real-world evidence for the safe and effective transition from BZRAs to daridorexant in clinical practice.
Detailed description
Detailed Description:
Background: Insomnia is a prevalent disorder that significantly impacts quality of life and daytime functioning. Benzodiazepine receptor agonists (BZRAs), including benzodiazepines and non-benzodiazepines, are commonly used but are associated with tolerance, dependence, withdrawal symptoms, and disruption of sleep architecture. Daridorexant, a dual orexin receptor antagonist (DORA), offers a novel mechanism by reducing hyperarousal and promoting physiological sleep, with a favorable safety profile and no withdrawal effects upon discontinuation. However, real-world evidence on transitioning patients from BZRAs to daridorexant remains limited.
Study Objective: To evaluate the efficacy and safety of transitioning adult insomnia patients from BZRAs to daridorexant in a clinical practice setting.
Study Design: This is a prospective, multicenter, open-label, cohort study. Patients will be enrolled across multiple sites in China. The study consists of two phases: a 1-week baseline phase (during which patients continue their usual BZRA therapy) and a 9-week daridorexant treatment phase. During the treatment phase, daridorexant 50 mg is initiated once daily, 30 minutes before bedtime, while the original BZRA is tapered and discontinued according to individual patient response, following a cross-tapering approach.
Population: A total of 156 adult patients (aged 18-70 years) with insomnia disorder according to DSM-5 criteria, who have been on stable BZRA monotherapy for at least 3 nights per week for the past month, and who are dissatisfied with or intolerant to their current therapy, will be enrolled. Key exclusion criteria include chronic insomnia >5 years, severe psychiatric disorders, significant comorbidities, and prior use of DORA agents without response.
Intervention: Daridorexant tablets (50 mg) taken orally once nightly. Dose adjustment to 25 mg is permitted based on tolerability, but the maximum dose is 50 mg daily.
Outcomes:
Primary Outcome: The proportion of patients who successfully transition from BZRAs to daridorexant at Week 5, defined as a ≥50% reduction or complete discontinuation of the original BZRA dose, with continued willingness to take daridorexant, and no withdrawal due to worsening insomnia or adverse events.
Secondary Outcomes: Changes from baseline in Insomnia Severity Index (ISI) scores; patient-reported sleep outcomes (subjective total sleep time, sleep quality) assessed by electronic sleep diary; and patterns of daridorexant and BZRA dosing adjustments.
Safety Outcomes: Incidence and severity of treatment-emergent adverse events (TEAEs); assessment of benzodiazepine withdrawal symptoms using the Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ).
Visit Schedule: Patients will undergo 6 visits: at Day 0 (V1, screening), Day 7 (V2, baseline, daridorexant initiation), Day 14 (V3), Day 21 (V4), Day 42 (V5, primary endpoint), and Day 70 (V6, end of treatment). Assessments include ISI, electronic sleep diary, BWSQ, and safety monitoring at each visit.
Sample Size: Based on an expected transition success rate of 80% at Week 5, with a 95% confidence interval and 10% margin of error, and accounting for a 10% dropout rate, a total of 156 patients will be enrolled (78 per BZRA subgroup).
Statistical Analysis: The primary analysis will be performed on the full analysis set (FAS). Descriptive statistics will be used for baseline characteristics. The primary endpoint will be presented with a 95% confidence interval. Secondary endpoints will be analyzed using appropriate parametric or non-parametric methods. Safety data will be summarized descriptively.
Ethical Considerations: The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. The protocol has been approved by the Ethics Committee of Xuanwu Hospital, Capital Medical University. Written informed consent will be obtained from all participants.
Expected Impact: This study aims to provide real-world evidence on the safe and effective transition from BZRAs to daridorexant, informing clinical decision-making and potentially improving long-term insomnia management in Chinese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daridorexant Transition Group | Experimental | Drug: DaridorexantParticipants receive daridorexant 50 mg orally once nightly for 9 weeks, with gradual tapering and discontinuation of their prior benzodiazepine receptor agonist (BZRA) therapy based on individual clinical response. Dose reduction of daridorexant to 25 mg is permitted if clinically indicated. The study includes 6 visits over 10 weeks, with the primary endpoint assessed at Week 5. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, aged ≥18 and ≤70 years.
- Meet DSM-5 diagnostic criteria for insomnia disorder: dissatisfaction with nighttime sleep despite adequate sleep opportunity, manifested as difficulty initiating sleep, difficulty maintaining sleep (frequent awakenings or difficulty returning to sleep after awakening), or early-morning awakening with inability to resume sleep, accompanied by subjective experience of daytime dysfunction. Symptoms occur ≥3 times per week and persist for ≥3 months.
- Received stable BZRA monotherapy for at least 3 nights per week during the 1 month prior to enrollment.
- Bedtime duration of no less than 7 hours per night.
- Unsatisfactory response or intolerance to current therapy, with clinical need to adjust insomnia medication regimen.
Key exclusion criteria (20 listed)
- History of chronic insomnia >5 years.
- Other sleep disorders such as narcolepsy-related symptoms, restless legs syndrome, circadian rhythm sleep disorder, REM sleep behavior disorder, etc.
- Daytime napping ≥1 hour/day and ≥3 days/week.
- Daily BZRA dose exceeding the maximum recommended dose for insomnia treatment per package insert.
- BZRA use >5 nights per week.
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 |
|---|---|---|
| DaridorexantAlso: QuviciqDaridorexant is a dual orexin receptor antagonist (DORA) supplied as 50 mg film-coated tablets for oral administration. Participants receive 50 mg once nightly, 30 minutes before bedtime, for up to 9 weeks. Dose reduction to 25 mg is permitted based on tolerability. The drug is provided by Jiangsu Simcere Pharmaceutical Co., Ltd. | Drug | Daridorexant Transition Group |
Primary outcome
Proportion of Participants Successfully Transitioning from BZRAs to Daridorexant at Week 5
Time frame: At Week 5 (Visit 5, Day 42 ± 3 days)
Defined as a ≥50% reduction or complete discontinuation of the original BZRA dose, with continued willingness to take daridorexant, and no withdrawal due to worsening insomnia or adverse events at Week 5 (Visit 5, Day 42 ± 3 days).
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 29 Jul 2026.
- Background: PubMed 34415378Roch C, Bergamini G, Steiner MA, Clozel M. Nonclinical pharmacology of daridorexant: a new dual orexin receptor antagonist for the treatment of insomnia. Psychopharmacology (Berl). 2021 Oct;238(10):2693-2708. doi: 10.1007/s00213-021-05954-0. Epub 2021 Aug 20.
- Background: PubMed 28663311Treiber A, de Kanter R, Roch C, Gatfield J, Boss C, von Raumer M, Schindelholz B, Muehlan C, van Gerven J, Jenck F. The Use of Physiology-Based Pharmacokinetic and Pharmacodynamic Modeling in the Discovery of the Dual Orexin Receptor Antagonist ACT-541468. J Pharmacol Exp Ther. 2017 Sep;362(3):489-503. doi: 10.1124/jpet.117.241596. Epub 2017 Jun 29.
- Individual participant dataSharing planned: No. We do not currently have a formal plan to share individual participant data (IPD). Any future data sharing will be considered on a case-by-case basis and will require approval from the Principal Investigator and the relevant Institutional Review Board (IRB), as well as execution of a data use agreement.
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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.
Zhan principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daridorexant in people with Insomnia Disorders, run by Xuanwu Hospital, Beijing at 1 site in China.
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 8 inclusion and 20 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Guo (025-85566666, guojingjing@simcere.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Successfully Transitioning from BZRAs to Daridorexant at Week 5 (time frame: At Week 5 (Visit 5, Day 42 ± 3 days)). 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 NCT07733414, which also lists 2 linked publications.
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 29 Jul 2026.