MigraineMIRANCT06862544
Migraine Research with Smartwatch Application
An observational study of Migraine, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
This clinical, prospective study aims to evaluate the effectiveness of wearable technology in capturing real-time data to assess disease activity in patients with episodic or chronic migraine undergoing different therapy strategies, including botulinum toxin, prophylactic, and acute treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Smartwatch (Withings Scanwatch 2)
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- 17 May 2024to 7 Mar 2025
- Phase
- Observational
- 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
Study population: Patients with episodic or chronic migraine 18 years or older
Who may be able to join
- Patients must meet the following criteria to be eligible to participate in the study:
- ≥ 18 years of age
- Diagnosed migraine syndrome
- Possession and ability to use a smartphone (Android 8.1 or later, or iOS 12.3 or later)
Who cannot join
- Missing informed consent
- Unwillingness or inability to use the smartphone app
- Comorbidity leading to impaired comprehension or successful completion of the study, such as (but not limited to) psychiatric comorbidities or dementia. The decision will be at the discretion of the investigators.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medical Faculty, Heinrich-Heine-University
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Migraine Research with Smartwatch Application (MIRA) - a Prospective Migraine Study with Wearables
This clinical, prospective study aims to evaluate the effectiveness of wearable technology in capturing real-time data to assess disease activity in patients with episodic or chronic migraine undergoing different therapy strategies, including botulinum toxin, prophylactic, and acute treatments. Participants will also document migraine attacks, triggers, and symptoms through a digital migraine diary app. By combining continuous smartwatch data, the migraine diary and the implementation of questionnaires, the study seeks to provide a comprehensive understanding of how migraines and their treatments impact daily life and patient outcomes.
Read the detailed description
Migraine is one of the most prevalent neurological disorders globally, significantly affecting patients' quality of life. However, due to the complexity of monitoring triggers and symptoms, determining the most effective individualized treatment regimen can be difficult. In this observational study a total of 55 patients with episodic or chronic migraines have been observed over a six-month period, with continuous data collection from both smartwatch and migraine diary app. Clinical health questionnaires were completed at baseline (V1), 3 months (V2), and 6 months (V3), assessing the impact of migraine attacks on daily functioning. The data gathered from the smartwatch (Withings ScanWatch) includes activity-related metrics (step count, minutes of activity at various intensity levels), basic cardiovascular measurements (heart rate), and sleep data (total sleep duration, sleep quality, etc.). Additionally, the Migraine App allows patients to document the precise timing of migraine attacks, associated symptoms, potential triggers, and the medications taken, including their effectiveness. The MIRA study aims to explore the potential of wearable devices and digital health tools to systematically identify migraine triggers and physiological responses through continuous monitoring. By integrating both clinical assessments and digital data, this study seeks to provide a comprehensive, longitudinal understanding of migraine dynamics and their impact on daily life.
- Conditions
- Migraine
- Being tested
- Smartwatch (Withings Scanwatch 2)
- Keywords
- Migraine, Headache, Smartwatch, Wearables, Digital health tools
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartwatch (Withings Scanwatch 2)Device
All-day monitoring of patients via smartwatch and migraine diary app
| Study group | Role | What they receive |
|---|---|---|
| Migraine patients | Patients with episodic or chronic migraine Receives: Device: Smartwatch (Withings Scanwatch 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-of-dose phenomena (EoD) in botulinum toxin therapy
The End-of-dose-phenomena-Questionnaire assesses the effectiveness of a treatment at the end of its dosing interval and asks about an increase in symptoms. Before their next botulinum toxin treatment, patients can state whether they have experienced a worsening of symptoms in recent weeks and, if so, for how many days and which migraine symptoms have worsened.
Measured: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Change in Quality of life (QoL)
WHOQoL-BREF (World Health Organization Quality of Life Questionnaire Brief Version) is an instrument for measuring patients' subjective quality of life in a wide range of specific areas including Physical health, Psychological well-being, Social relationships and Environment. The WHOQoL-BREF uses a score range of 4 to 20 for each domain in its raw form. These raw scores are then converted to a 0-100 scale, where higher scores indicate better quality of life and lower scores indicate poorer quality of life.
Measured: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Change in Migraine Disability (MIDAS)
MIDAS (Migraine Disability Assessment) is a standardized tool used to assess the impact of migraine on various aspects of life, including work, school, social activities, and leisure activities. It is calculated based on the number of days affected by migraines in the past three months with higher scores indicating greater disability and a more severe impact on daily activities. Lower scores suggest less disruption from migraines.
Measured: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Change in Pittsburgh Sleep Quality Index (PSQI)
The Change in Pittsburgh Sleep Quality Index (PSQI) is a tool to assess the quality of sleep over the past month. The score range for the PSQI is from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Change in fatigue severity (BFI)
Brief Fatigue Inventory (BFI) is a questionnaire to assess fatigue severity. The BFI consists of 9 questions, each answered on an 11-point scale. The total score on the BFI ranges from 0 to 10, where 0 represents no fatigue and 10 represents the worst possible fatigue. In general, higher scores indicate greater severity of fatigue, and lower scores suggest less severe or no fatigue.
Measured: Time frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Change in Depressive symptoms (BDI-FAST)
Beck Depression Inventory (BDI) FAST is a questionnaire to screen for depression in migraine patients. It is a shortened version of the full Beck Depression Inventory (BDI) and contains 7 items. Each item is scored on a 4-point scale (0 to 3), with a higher score indicating more severe depressive symptoms.
Measured: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Smartwatch usage
Questionnaire about smartwatch usage. Patients are presented with 17 statements about the smartwatches, focusing on practicality, usability, and everyday suitability. They can score each statement from 1 to 5, where 5 means strong agreement and 1 means strong disagreement.
Measured: After 6 months (V3)
Migraine Triggers
Migraine Triggers through migraine diary
Measured: 180 days
Medication taken during migraine attacks
Medication taken during migraine attacks through migraine diary
Measured: 180 days
Duration of migraine attacks
Duration of migraine attacks through migraine diary
Measured: 180 days
Pain level and localization of headache
Pain level and localization of headache through migraine diary. For each migraine attack there is a Numerical Rating Scale (NRS) - a simple method for pain assessment, where patients rate their pain on a scale from 0 to 10. In the migraine app, patients can specify the exact location of their headache. A front view of the head with 12 sections and a back view with 6 sections are presented. Patients can select multiple sections to visually pinpoint the headache location.
Measured: 180 days
Wearing time of smartwatch (daily)
Measured: 180 days
Longitudinal development of activity parameter: step count
Measured: 180 days
Longitudinal development of activity parameter: approximate distance traveled (meter)
Measured: 180 days
Longitudinal development of activity parameter: duration of soft activity (seconds) defined by Withings Description: Examples for soft activity: Sleeping, Sitting quietly, Walking slowly, Typing on a computer keyboard while seated, Watching televisio
Measured: 180 days
Longitudinal development of activity parameter: duration of moderate activity (seconds) defined by Withings Description: Examples for moderate activity: Walking fast, Cleaning (vacuuming, washing windows, etc.), Playing doubles tennis or badminton, T
Measured: 180 days
Longitudinal development of activity parameter: duration of intense activity (seconds) defined by Withings Description: Examples for intense activity: Hiking, Running, Carrying heavy loads, Riding a bike, Playing football, baseball, or tennis (singles),
Measured: 180 days
Longitudinal development of activity parameter: sum of all active time (seconds)
Measured: 180 days
Longitudinal development of activity parameter: approximate calories burned Time
Measured: 180 days
Longitudinal development of sleep parameter: time awake (seconds)
Measured: 180 days
Longitudinal development of sleep parameter: number of times user woke up
Measured: 180 days
Longitudinal development of sleep parameter: time to sleep (seconds)
Measured: 180 days
Longitudinal development of sleep parameter: total time in bed (seconds)
Measured: 180 days
Longitudinal development of sleep parameter: total time asleep (seconds)
Measured: 180 days
Longitudinal development of sleep parameter: ratio of sleep/time in bed
Measured: 180 days
Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)
Measured: 180 days
Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)
Measured: 180 days
Longitudinal development of sleep parameter: Withings Sleep score Description: Defined by Withings as follows: It measures every night's sleep and provides a score out of 100 points based on 4 key inputs: - Duration (total time spent sleeping) - Depth (p
Measured: 180 days
Longitudinal development of cardiovascular parameter: average heartrate
Measured: 180 days
Longitudinal development of cardiovascular parameter: maximal heartrate
Measured: 180 days
Longitudinal development of cardiovascular parameter: minimum heartrate
Measured: 180 days
Longitudinal development of cardiovascular parameter: time in light heartrate zone (seconds) Description: Light heartrate zone is defined by Withings as follows: from 0% inclusive to 50% exclusive of maximum heart rate.
Measured: 180 days
Longitudinal development of cardiovascular parameter: time in moderate heartrate zone (seconds) Description: Moderate heartrate zone is defined by Withings as follows: from 50% included to 70% excluded of maximal heart rate.
Measured: 180 days
Longitudinal development of cardiovascular parameter: time in intense heartrate zone (seconds) Description: Intense heartrate zone is defined by Withings as follows: from 70% included to 90% excluded of maximal heart rate.
Measured: 180 days
Longitudinal development of cardiovascular parameter: time in maximal heartrate zone (seconds) Description: Maximal heartrate zone is defined by Withings as follows: from 90% included to 100% included of maximal heart rate
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start17 May 2024
- Primary completion7 Mar 2025 (estimated)
- Study completion7 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862544
- Sponsor's protocol ID
- MIRA_1.0
- Acronym
- MIRA
- Status last verified
- Feb 2025
- First submitted
- 2 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine Research with Smartwatch Application (MIRA) - a Prospective Migraine Study with Wearables
- ClinicalTrials.gov ID
- NCT06862544
- Acronym / sponsor ID
- MIRA / MIRA_1.0
- Conditions
- Migraine
- Keywords
- Migraine, Headache, Smartwatch, Wearables, Digital health tools
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 7 Mar 2025 (estimated)
- Study completion
- 7 Mar 2025 (estimated)
- First posted
- 6 Mar 2025 (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.
This clinical, prospective study aims to evaluate the effectiveness of wearable technology in capturing real-time data to assess disease activity in patients with episodic or chronic migraine undergoing different therapy strategies, including botulinum toxin, prophylactic, and acute treatments. Participants will also document migraine attacks, triggers, and symptoms through a digital migraine diary app. By combining continuous smartwatch data, the migraine diary and the implementation of questionnaires, the study seeks to provide a comprehensive understanding of how migraines and their treatments impact daily life and patient outcomes.
Detailed description
Migraine is one of the most prevalent neurological disorders globally, significantly affecting patients' quality of life. However, due to the complexity of monitoring triggers and symptoms, determining the most effective individualized treatment regimen can be difficult. In this observational study a total of 55 patients with episodic or chronic migraines have been observed over a six-month period, with continuous data collection from both smartwatch and migraine diary app. Clinical health questionnaires were completed at baseline (V1), 3 months (V2), and 6 months (V3), assessing the impact of migraine attacks on daily functioning. The data gathered from the smartwatch (Withings ScanWatch) includes activity-related metrics (step count, minutes of activity at various intensity levels), basic cardiovascular measurements (heart rate), and sleep data (total sleep duration, sleep quality, etc.). Additionally, the Migraine App allows patients to document the precise timing of migraine attacks, associated symptoms, potential triggers, and the medications taken, including their effectiveness. The MIRA study aims to explore the potential of wearable devices and digital health tools to systematically identify migraine triggers and physiological responses through continuous monitoring. By integrating both clinical assessments and digital data, this study seeks to provide a comprehensive, longitudinal understanding of migraine dynamics and their impact on daily life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Migraine patients | – | Device: Smartwatch (Withings Scanwatch 2)Patients with episodic or chronic migraine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with episodic or chronic migraine 18 years or older
Key inclusion criteria (4 listed)
- ≥ 18 years of age
- Diagnosed migraine syndrome
- Possession and ability to use a smartphone (Android 8.1 or later, or iOS 12.3 or later)
Key exclusion criteria (3 listed)
- Missing informed consent
- Unwillingness or inability to use the smartphone app
- Comorbidity leading to impaired comprehension or successful completion of the study, such as (but not limited to) psychiatric comorbidities or dementia. The decision will be at the discretion of the investigators.
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 |
|---|---|---|
| Smartwatch (Withings Scanwatch 2)All-day monitoring of patients via smartwatch and migraine diary app | Device | Migraine patients |
Primary outcome
End-of-dose phenomena (EoD) in botulinum toxin therapy
Time frame: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
The End-of-dose-phenomena-Questionnaire assesses the effectiveness of a treatment at the end of its dosing interval and asks about an increase in symptoms. Before their next botulinum toxin treatment, patients can state whether they have experienced a worsening of symptoms in recent weeks and, if so, for how many days and which migraine symptoms have worsened.
Change in Quality of life (QoL)
Time frame: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
WHOQoL-BREF (World Health Organization Quality of Life Questionnaire Brief Version) is an instrument for measuring patients' subjective quality of life in a wide range of specific areas including Physical health, Psychological well-being, Social relationships and Environment. The WHOQoL-BREF uses a score range of 4 to 20 for each domain in its raw form. These raw scores are then converted to a 0-100 scale, where higher scores indicate better quality of life and lower scores indicate poorer quality of life.
Change in Migraine Disability (MIDAS)
Time frame: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
MIDAS (Migraine Disability Assessment) is a standardized tool used to assess the impact of migraine on various aspects of life, including work, school, social activities, and leisure activities. It is calculated based on the number of days affected by migraines in the past three months with higher scores indicating greater disability and a more severe impact on daily activities. Lower scores suggest less disruption from migraines.
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
The Change in Pittsburgh Sleep Quality Index (PSQI) is a tool to assess the quality of sleep over the past month. The score range for the PSQI is from 0 to 21, with higher scores indicating poorer sleep quality.
Change in fatigue severity (BFI)
Time frame: Time frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Brief Fatigue Inventory (BFI) is a questionnaire to assess fatigue severity. The BFI consists of 9 questions, each answered on an 11-point scale. The total score on the BFI ranges from 0 to 10, where 0 represents no fatigue and 10 represents the worst possible fatigue. In general, higher scores indicate greater severity of fatigue, and lower scores suggest less severe or no fatigue.
Change in Depressive symptoms (BDI-FAST)
Time frame: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Beck Depression Inventory (BDI) FAST is a questionnaire to screen for depression in migraine patients. It is a shortened version of the full Beck Depression Inventory (BDI) and contains 7 items. Each item is scored on a 4-point scale (0 to 3), with a higher score indicating more severe depressive symptoms.
Smartwatch usage
Time frame: After 6 months (V3)
Questionnaire about smartwatch usage. Patients are presented with 17 statements about the smartwatches, focusing on practicality, usability, and everyday suitability. They can score each statement from 1 to 5, where 5 means strong agreement and 1 means strong disagreement.
Migraine Triggers
Time frame: 180 days
Migraine Triggers through migraine diary
Medication taken during migraine attacks
Time frame: 180 days
Medication taken during migraine attacks through migraine diary
Duration of migraine attacks
Time frame: 180 days
Duration of migraine attacks through migraine diary
Pain level and localization of headache
Time frame: 180 days
Pain level and localization of headache through migraine diary. For each migraine attack there is a Numerical Rating Scale (NRS) - a simple method for pain assessment, where patients rate their pain on a scale from 0 to 10. In the migraine app, patients can specify the exact location of their headache. A front view of the head with 12 sections and a back view with 6 sections are presented. Patients can select multiple sections to visually pinpoint the headache location.
Wearing time of smartwatch (daily)
Time frame: 180 days
Longitudinal development of activity parameter: step count
Time frame: 180 days
Longitudinal development of activity parameter: approximate distance traveled (meter)
Time frame: 180 days
Longitudinal development of activity parameter: duration of soft activity (seconds) defined by Withings Description: Examples for soft activity: Sleeping, Sitting quietly, Walking slowly, Typing on a computer keyboard while seated, Watching televisio
Time frame: 180 days
Longitudinal development of activity parameter: duration of moderate activity (seconds) defined by Withings Description: Examples for moderate activity: Walking fast, Cleaning (vacuuming, washing windows, etc.), Playing doubles tennis or badminton, T
Time frame: 180 days
Longitudinal development of activity parameter: duration of intense activity (seconds) defined by Withings Description: Examples for intense activity: Hiking, Running, Carrying heavy loads, Riding a bike, Playing football, baseball, or tennis (singles),
Time frame: 180 days
Longitudinal development of activity parameter: sum of all active time (seconds)
Time frame: 180 days
Longitudinal development of activity parameter: approximate calories burned Time
Time frame: 180 days
Longitudinal development of sleep parameter: time awake (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: number of times user woke up
Time frame: 180 days
Longitudinal development of sleep parameter: time to sleep (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: total time in bed (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: total time asleep (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: ratio of sleep/time in bed
Time frame: 180 days
Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: Withings Sleep score Description: Defined by Withings as follows: It measures every night's sleep and provides a score out of 100 points based on 4 key inputs: - Duration (total time spent sleeping) - Depth (p
Time frame: 180 days
Longitudinal development of cardiovascular parameter: average heartrate
Time frame: 180 days
Longitudinal development of cardiovascular parameter: maximal heartrate
Time frame: 180 days
Longitudinal development of cardiovascular parameter: minimum heartrate
Time frame: 180 days
Longitudinal development of cardiovascular parameter: time in light heartrate zone (seconds) Description: Light heartrate zone is defined by Withings as follows: from 0% inclusive to 50% exclusive of maximum heart rate.
Time frame: 180 days
Longitudinal development of cardiovascular parameter: time in moderate heartrate zone (seconds) Description: Moderate heartrate zone is defined by Withings as follows: from 50% included to 70% excluded of maximal heart rate.
Time frame: 180 days
Longitudinal development of cardiovascular parameter: time in intense heartrate zone (seconds) Description: Intense heartrate zone is defined by Withings as follows: from 70% included to 90% excluded of maximal heart rate.
Time frame: 180 days
Longitudinal development of cardiovascular parameter: time in maximal heartrate zone (seconds) Description: Maximal heartrate zone is defined by Withings as follows: from 90% included to 100% included of maximal heart rate
Time frame: 180 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 14 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 14 Mar 2025. 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 Germany. 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?
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?
End-of-dose phenomena (EoD) in botulinum toxin therapy (time frame: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)). The study lists 35 primary outcomes in all. 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 14 Mar 2025.