Minor StrokeNCT04945174
Stroke School -Including Physical Exercise, Patient Education and Individual Follow-up Sessions
A study testing Cardiorespiratory exercise combined with patient education and individual follow-up sessions in people with Minor Stroke and Non-disabling Stroke, run by Herlev Hospital at 2 sites in Denmark.
Trial summary
In a randomized controlled trial the effect of 12 weeks of cross-sectorial physical exercise combined with patient education and individual follow-up session is investigated in patients with minor stroke or non-disabling stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minor Stroke, Non-disabling Stroke, Transient Ischemic Attack
- What is being tested?
- Cardiorespiratory exercise combined with patient education and individual follow-up sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jun 2022to Dec 2033
- Phase
- Interventional
- 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
- Patients with a minor stroke or TIA without the need of rehabilitation after hospital discharge, but need physical activity in order to prevent cardiovascular diseases
- Patients spending ≤ 5 hour of leisure time on high-intensity physical activity on weekly basis within the last 3 months
- Able to speak and read Danish and to provide informed consent
- Individuals ≥ 18 years of age
Who cannot join
- Previous large-artery stroke or hemorrhagic stroke
- Unstable cardiac condition, e.g. pacemaker
- Uncontrolled hypertension (patients not responding adequately to antihypertensive medication when applying treatment according to guidelines)
- Symptoms or comorbidities not allowing exercise on a stationary bicycle (e.g. claudication)
- Dyspnoea caused by heart or pulmonary disease (e.g. COPD)
- Aphasia, or dementia that interferer with understanding the protocol and/or physical examinations.
- Patients diagnosed with dementia at hospital admission (a score ≤23/30 on the Mini-Mental State Examination are not invited into the study)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Herlev Hospital
Copenhagen, Herlev, 2730
Christina Kruuse, Professor, +45 3868 1233, christina.kruuse@regionh.dk
Rikke Steen Krawcyk, ph.d., +45 3868 6159, rikke.steen.krawcyk@regionh.dk
- Recruiting
Department of Neurology, Herlev-Gentofte Hospital
Herlev, 2730
Christina Kruuse, MD, DMSc, +4538681233
About this study
Official title: Stroke School - Cross-sectorial Physical Exercise for Patients With Minor Stroke or Non-disabling Stroke
In a randomized controlled trial the effect of 12 weeks of cross-sectorial physical exercise combined with patient education and individual follow-up session is investigated in patients with minor stroke or non-disabling stroke.
Read the detailed description
Hypertension and physical inactivity are the most common risk factors for stroke. Patients with minor stroke or transient ischemic attack (TIA) have short-lasting symptoms, often with remission within hours or days. Though patients experience a quick remission, they have an increased risk of a recurrent stroke and progressive cognitive dysfunction. The patients are also likely to have other disposing risk factors such as diabetes, smoking, and hypercholesterolemia which may increase the risk of a recurrent stroke. Following hospital discharge, the patients are offered preventive medication, but no standardized rehabilitation or exercise. Previous studies have shown that physical exercise decreases cardiovascular risk factors for patients after stroke and increases physical function and quality of life.
The aim is to develop and evaluate a standardized exercise program (a stroke school) for patients with minor stroke or TIA. The intervention consist of 6 weeks of supervised aerobic exercise at the hospital combined with patient education including knowledge on stroke risk factors. Subsequently, 6 weeks of supervised aerobic exercise in their local municipality. After the 12 weeks of exercise, patients are offered individual, motivational follow-up sessions with the purpose to facilitate the patients to stay physically active in their everyday life.
This intervention will increase the patients´ knowledge regarding risk factors for stroke and cardiovascular disease, increase their cardiorespiratory fitness and facilitate the patients to be physical active and hopefully slow the progression of vascular disease.
- Being tested
- Cardiorespiratory exercise combined with patient education and individual follow-up sessions
- Keywords
- Minor stroke, Stroke prevention, Physical exercise, Patient education, Cardiorespiratory fitness, Non-disabling stroke
- Medical subject headings
- Ischemic Attack, Transient, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiorespiratory exercise combined with patient education and individual follow-up sessionsBehavioural
6 weeks of cardiorespiratory exercise combined with patient education at the hospital, followed by 6 weeks of cardiorespiratory exercise in the local municipality. Subsequently individual follow-up sessions with the aim to facilitate the patients to stay physically active in their everyday life
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | 12 weeks of supervised cardiorespiratory exercise twice a week (6 weeks at the hospital and 6 weeks in the local municipality) combined with patient education and individual follow-up sessions Receives: Behavioral: Cardiorespiratory exercise combined with patient education and individual follow-up sessions |
| Usual care | No intervention | The usual care group is encouraged to perform home-based aerobic exercise on their own |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 'the Graded Cycling Test with Talk Test' from baseline to 3 months
A sub-maximal exercise test on a stationary bicycle where the workload increases by 15 Watts (W) every minute and each minute the patient recites a standardized text passage. When the patient is no longer able to speak comfortably the test terminates. The higher score the better cardiorespiratory fitness
Measured: from baseline to 3 months (post-intervention)
Secondary outcomes (28)
Change in Physical Activity Scale
A questionnaire measuring number of hours of self-reported physical activity during daily living. It reveals daily time spent on sleep, sitting down at work, standing/walking at work, heavy physical work during working hours, active commuting to/from work, and sedentary behavior, including television watching and reading. Additionally, the patients record the weekly time spent on light-intensity, moderate-intensity, and vigorous-intensity activity during leisure time.
Measured: from baseline to 3 months (post-intervention)
Change in Physical Activity Scale from baseline to 12-months post-stroke
A questionnaire measuring number of hours of self-reported physical activity during daily living. It reveals daily time spent on sleep, sitting down at work, standing/walking at work, heavy physical work during working hours, active commuting to/from work, and sedentary behavior, including television watching and reading. Additionally, the patients record the weekly time spent on light-intensity, moderate-intensity, and vigorous-intensity activity during leisure time.
Measured: From baseline to 12-months post-stroke
Change in maximum cardiopulmonary exercise test from baseline to 3 months post-stroke
A maximal exercise test on a stationary bicycle
Measured: from baseline to 3 months (post-intervention)
Change in The WHO-5 Well-being index from baseline to to 3 months post-stroke
A questionnaire measuring current mental well-being on a scale from 0-100 points where higher points indicates better mental well-being
Measured: from baseline to 3 months (post-intervention)
Change in The WHO-5 Well-being index from baseline to 12-months post-stroke
A questionnaire measuring current mental well-being on a scale from 0-100 points where higher points indicates better mental well-being
Measured: From baseline to 12-months post-stroke
Change in Montreal Cognitive Assessment from baseline to 3 months post-stroke
A cognitive screening test for detection of mild cognitive impairments, the score ranges from 0-30 points and a high score indicates better cognitive function
Measured: from baseline to 3 months (post-intervention)
Change in Montreal Cognitive Assessment from baseline to 12-months post-stroke
A cognitive screening test for detection of mild cognitive impairments, the score ranges from 0-30 points and a high score indicates better cognitive function
Measured: From baseline to 12-months post-stroke
Change in Anxiety and depression from baseline to 3 months post-stroke
This is a self-reported questionnaire that measures anxiety and depression. A total score of 0-21 points is possible, with a higher score indicating more severe symptoms of depression or anxiety.
Measured: from baseline to 3 months (post-intervention)
Change in Anxiety and depression from baseline 12-months post-stroke
This is a self-reported questionnaire that measures anxiety and depression. A total score of 0-21 points is possible, with a higher score indicating more severe symptoms of depression or anxiety.
Measured: From baseline 12-months post-stroke
Change in Fatigue Severity Scale from baseline to 3 months post-stroke
A 20-item self-report instrument designed to measure fatigue. The score ranges from 9-63 points, and a higher score indicates greater severity of fatigue
Measured: from baseline to 3 months (post-intervention)
Change in Fatigue Severity Scale from baseline to 12-months post-stroke
A 20-item self-report instrument designed to measure fatigue. The score ranges from 9-63 points, and a higher score indicates greater severity of fatigue
Measured: From baseline to 12-months post-stroke
Change in The Multidimensional Fatigue Inventory from baseline to 3-months post-stroke
Four questions on General fatigue is calculated on a score from 4-20, with higher scores representing increased fatigue
Measured: From baseline to 12-months post-stroke
Change in The Multidimensional Fatigue Inventory from baseline to 12-months post-stroke
Four questions on General fatigue is calculated on a score from 4-20, with higher scores representing increased fatigue
Measured: From baseline to 12-months post-stroke
Change in blood pressure from baseline to 3 months post-stroke
Assessment of blood pressure (systolic and diastolic)
Measured: from baseline to 3 months (post-intervention)
Change in blood pressure from baseline to 12-months post-stroke
Assessment of blood pressure (systolic and diastolic)
Measured: From baseline to 12-months post-stroke
Change in body mass index from baseline to 3 months post-stroke
Measures of weight in kilograms, and height in meters will be aggregated to arrive at one reported value, the body mass index (kg/m^2).
Measured: from baseline to 3 months (post-intervention)
Change in body mass index from baseline to 12-months post-stroke
Measures of weight in kilograms, and height in meters will be aggregated to arrive at one reported value, the body mass index (kg/m^2).
Measured: From baseline to 12-months post-stroke
Change in Modified rankin scale from baseline to 3 months post-stroke
A measurement of symptoms/motor function. The score ranges from 0-6 points, where 0 represents "no symptoms at all" and 6 points represents "dead".
Measured: from baseline to 3 months (post-intervention)
Change in Modified rankin scale from baseline to 12-months post-stroke
A measurement of symptoms/motor function. The score ranges from 0-6 points, where 0 represents "no symptoms at all" and 6 points represents "dead".
Measured: From baseline to 12-months post-stroke
Change in high-sensitivity C-reactive protein from baseline to 3 months post-stroke
Blood samples to evaluate degree of inflammation (low risk: < 1 mg/L, average risk: 1-3 mg/L, and high risk: >3 mg/L).
Measured: from baseline to 3 months (post-intervention)
Change in high-sensitivity C-reactive protein from baseline to 12-months post-stroke
Blood samples to evaluate degree of inflammation (low risk: < 1 mg/L, average risk: 1-3 mg/L, and high risk: >3 mg/L).
Measured: From baseline to 12-months post-stroke
Change in Pro brain natriuretic peptid from baseline to 3 months post-stroke
Blood samples to evaluate cardiac function (normal: < 125 pg/mL, critical value: > 400 pg/mL)
Measured: from baseline to 3 months (post-intervention)
Change in Pro brain natriuretic peptid from baseline to 12-months post-stroke
Blood samples to evaluate cardiac function (normal: < 125 pg/mL, critical value: > 400 pg/mL)
Measured: From baseline to 12-months post-stroke
Change in Cathepsin B from baseline to 3 months post-stroke
Blood samples to evaluate muscle protein. (high level of Cathepsin B may associate to improve cognitive function)
Measured: from baseline to 3 months (post-intervention)
Change in Cathepsin B from baseline to 12-months post-stroke
Blood samples to evaluate muscle protein. (high level of Cathepsin B may associate to improve cognitive function)
Measured: From baseline to 12-months post-stroke
Change in Magnetic Resonance Imaging from baseline to 12-months post-stroke
detection of number of new infarcts or white matter lesions
Measured: From baseline to 12-months post-stroke
Change in the Stages of exercise behavior change from baseline to 3 months post-stroke
A questionnaire consisting of six categories describing differerent stages towards exercise behavior change, ranking from no intention to change behavior (precontemplation) to sustain behavior change (maintenance).
Data will be analysed by calculating the number of patients (percentage) in each category and with a comparison between groups
Measured: from baseline to 3 months (post-intervention)
Change in the Stages of exercise behavior change from baseline to 12-months post-stroke
A questionnaire consisting of six categories describing differerent stages towards exercise behavior change, ranking from no intention to change behavior (precontemplation) to sustain behavior change (maintenance).
Data will be analysed by calculating the number of patients (percentage) in each category and with a comparison between groups
Measured: From baseline to 12-months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start1 Jun 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minor StrokeStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Kruuse, Herlev Hospital
- Investigators
- Christina Kruuse, Professor, Principal investigator, Herlev Gentofte Hospital, Department of NeurologyAnders Hougaard, MD, Ph.d., Study director, Herlev Gentofte hospital, Department of Neurology,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945174
- Sponsor's protocol ID
- H-20059985
- Status last verified
- Feb 2025
- First submitted
- 27 Apr 2021
- Last updated
- 2 May 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 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke School - Cross-sectorial Physical Exercise for Patients With Minor Stroke or Non-disabling Stroke
- ClinicalTrials.gov ID
- NCT04945174
- Acronym / sponsor ID
- H-20059985
- Keywords
- Minor stroke, Stroke prevention, Physical exercise, Patient education, Cardiorespiratory fitness, Non-disabling stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 30 Jun 2021 (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.
In a randomized controlled trial the effect of 12 weeks of cross-sectorial physical exercise combined with patient education and individual follow-up session is investigated in patients with minor stroke or non-disabling stroke.
Detailed description
Hypertension and physical inactivity are the most common risk factors for stroke. Patients with minor stroke or transient ischemic attack (TIA) have short-lasting symptoms, often with remission within hours or days. Though patients experience a quick remission, they have an increased risk of a recurrent stroke and progressive cognitive dysfunction. The patients are also likely to have other disposing risk factors such as diabetes, smoking, and hypercholesterolemia which may increase the risk of a recurrent stroke. Following hospital discharge, the patients are offered preventive medication, but no standardized rehabilitation or exercise. Previous studies have shown that physical exercise decreases cardiovascular risk factors for patients after stroke and increases physical function and quality of life.
The aim is to develop and evaluate a standardized exercise program (a stroke school) for patients with minor stroke or TIA. The intervention consist of 6 weeks of supervised aerobic exercise at the hospital combined with patient education including knowledge on stroke risk factors. Subsequently, 6 weeks of supervised aerobic exercise in their local municipality. After the 12 weeks of exercise, patients are offered individual, motivational follow-up sessions with the purpose to facilitate the patients to stay physically active in their everyday life.
This intervention will increase the patients´ knowledge regarding risk factors for stroke and cardiovascular disease, increase their cardiorespiratory fitness and facilitate the patients to be physical active and hopefully slow the progression of vascular disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Behavioral: Cardiorespiratory exercise combined with patient education and individual follow-up sessions12 weeks of supervised cardiorespiratory exercise twice a week (6 weeks at the hospital and 6 weeks in the local municipality) combined with patient education and individual follow-up sessions |
| Usual care | No intervention | –The usual care group is encouraged to perform home-based aerobic exercise on their own |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a minor stroke or TIA without the need of rehabilitation after hospital discharge, but need physical activity in order to prevent cardiovascular diseases
- Patients spending ≤ 5 hour of leisure time on high-intensity physical activity on weekly basis within the last 3 months
- Able to speak and read Danish and to provide informed consent
- Individuals ≥ 18 years of age
Key exclusion criteria (7 listed)
- Previous large-artery stroke or hemorrhagic stroke
- Unstable cardiac condition, e.g. pacemaker
- Uncontrolled hypertension (patients not responding adequately to antihypertensive medication when applying treatment according to guidelines)
- Symptoms or comorbidities not allowing exercise on a stationary bicycle (e.g. claudication)
- Dyspnoea caused by heart or pulmonary disease (e.g. COPD)
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 |
|---|---|---|
| Cardiorespiratory exercise combined with patient education and individual follow-up sessions6 weeks of cardiorespiratory exercise combined with patient education at the hospital, followed by 6 weeks of cardiorespiratory exercise in the local municipality. Subsequently individual follow-up sessions with the aim to facilitate the patients to stay physically active in their everyday life | Behavioural | Exercise |
Primary outcome
Change in 'the Graded Cycling Test with Talk Test' from baseline to 3 months
Time frame: from baseline to 3 months (post-intervention)
A sub-maximal exercise test on a stationary bicycle where the workload increases by 15 Watts (W) every minute and each minute the patient recites a standardized text passage. When the patient is no longer able to speak comfortably the test terminates. The higher score the better cardiorespiratory fitness
28 secondary outcomes
Change in Physical Activity Scale
Time frame: from baseline to 3 months (post-intervention)
Change in Physical Activity Scale from baseline to 12-months post-stroke
Time frame: From baseline to 12-months post-stroke
Change in maximum cardiopulmonary exercise test from baseline to 3 months post-stroke
Time frame: from baseline to 3 months (post-intervention)
Change in The WHO-5 Well-being index from baseline to to 3 months post-stroke
Time frame: from baseline to 3 months (post-intervention)
Change in The WHO-5 Well-being index from baseline to 12-months post-stroke
Time frame: From baseline to 12-months post-stroke
Change in Montreal Cognitive Assessment from baseline to 3 months post-stroke
Time frame: from baseline to 3 months (post-intervention)
Change in Montreal Cognitive Assessment from baseline to 12-months post-stroke
Time frame: From baseline to 12-months post-stroke
Change in Anxiety and depression from baseline to 3 months post-stroke
Time frame: from baseline to 3 months (post-intervention)
Change in Anxiety and depression from baseline 12-months post-stroke
Time frame: From baseline 12-months post-stroke
Change in Fatigue Severity Scale from baseline to 3 months post-stroke
Time frame: from baseline to 3 months (post-intervention)
Change in Fatigue Severity Scale from baseline to 12-months post-stroke
Time frame: From baseline to 12-months post-stroke
Change in The Multidimensional Fatigue Inventory from baseline to 3-months post-stroke
Time frame: From baseline to 12-months post-stroke
Change in The Multidimensional Fatigue Inventory from baseline to 12-months post-stroke
Time frame: From baseline to 12-months post-stroke
Change in blood pressure from baseline to 3 months post-stroke
Time frame: from baseline to 3 months (post-intervention)
Change in blood pressure from baseline to 12-months post-stroke
Time frame: From baseline to 12-months post-stroke
Change in body mass index from baseline to 3 months post-stroke
Time frame: from baseline to 3 months (post-intervention)
Change in body mass index from baseline to 12-months post-stroke
Time frame: From baseline to 12-months post-stroke
Change in Modified rankin scale from baseline to 3 months post-stroke
Time frame: from baseline to 3 months (post-intervention)
Change in Modified rankin scale from baseline to 12-months post-stroke
Time frame: From baseline to 12-months post-stroke
Change in high-sensitivity C-reactive protein from baseline to 3 months post-stroke
Time frame: from baseline to 3 months (post-intervention)
Change in high-sensitivity C-reactive protein from baseline to 12-months post-stroke
Time frame: From baseline to 12-months post-stroke
Change in Pro brain natriuretic peptid from baseline to 3 months post-stroke
Time frame: from baseline to 3 months (post-intervention)
Change in Pro brain natriuretic peptid from baseline to 12-months post-stroke
Time frame: From baseline to 12-months post-stroke
Change in Cathepsin B from baseline to 3 months post-stroke
Time frame: from baseline to 3 months (post-intervention)
Change in Cathepsin B from baseline to 12-months post-stroke
Time frame: From baseline to 12-months post-stroke
Change in Magnetic Resonance Imaging from baseline to 12-months post-stroke
Time frame: From baseline to 12-months post-stroke
Change in the Stages of exercise behavior change from baseline to 3 months post-stroke
Time frame: from baseline to 3 months (post-intervention)
Change in the Stages of exercise behavior change from baseline to 12-months post-stroke
Time frame: From baseline to 12-months post-stroke
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 2 May 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.
Christina Kruuse, Professor principal investigator
Herlev Gentofte Hospital, Department of Neurology
Anders Hougaard, MD, Ph.d. study director
Herlev Gentofte hospital, Department of Neurology,
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiorespiratory exercise combined with patient education and individual follow-up sessions in people with Minor Stroke and Non-disabling Stroke, run by Herlev Hospital at 2 sites in Denmark.
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 7 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: looking for participants now, as of the sponsor's last update on 2 May 2025. 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 Denmark. 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?
Contact Christina Kruuse, Professor (+45 3868 1233, christina.kruuse@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 'the Graded Cycling Test with Talk Test' from baseline to 3 months (time frame: from baseline to 3 months (post-intervention)). 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 2 May 2025.