StrokeEFODINNCT07056049
The Efficacy of Additional Motor Training Dosage During the Early Stages Post Stroke on the Upper Extremity Recovery
A study testing High dosage, high intensity motor rehabilitation in people with Stroke and Hemiplegia and Hemiparesis, run by Adi Negev-Nahalat Eran at 2 sites in Israel.
Trial summary
Intervention abstract Background: Stroke is the leading cause of long-term disability, and the second leading cause of death in the western world. Most stroke survivors will suffer from motor and cognitive disturbances for the rest of their life, which negatively affects their normal daily life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiplegia and Hemiparesis
- What is being tested?
- High dosage, high intensity motor rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesIsrael
- Study dates
- 13 Jul 2025to 15 Jul 2027
- 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
- Age ≥18 years
- Ischemic or hemorrhagic stroke (hemispheric or brainstem) confirmed by CT or MRI
- First-ever stroke or previous stroke with no upper extremity weakness
- 1 week ≤ Time after stroke onset ≤ 6 weeks
- Active shoulder flexion of at least 20◦ and partial wrist and/or finger active movement
- Ability to provide inform consent
Who cannot join
- A painful shoulder limiting an active forward reach
- Severe spasticity or non-neural loss of range of motion
- Cognitive or communication impairments as determined by the clinical team Unstable medical conditions
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel2 sites, 2 recruiting
- Not yet recruiting
Adi Negev-Nahalat Eran
Ofakim
Lior Shmuelof, Prof., +972 0547510795, shmuelof@bgu.ac.il
Lior Shmuelof, Prof.
- Recruiting
Adi Negev-Nahalat Eran
Ofakim
Gil Meir, +9720548340307, gilmeir10@gmail.com
About this study
Official title: Efficacy of High-dosage, High-intensity Rehabilitation Program on the Motor Recovery After Stroke in Subacute Patients
Intervention abstract
Background: Stroke is the leading cause of long-term disability, and the second leading cause of death in the western world. Most stroke survivors will suffer from motor and cognitive disturbances for the rest of their life, which negatively affects their normal daily life.
Read more
Despite the decline in stroke-related mortality over the past decades, the outcome of rehabilitation programs does not improve, and is predictable regardless of the program used. Still, several human and animal studies show that high capacity of training in the early stages post stroke improve motor recovery. This notion is far from being well established.
Aim: Studying the effect of high-dosage, high-intensity training program in the subacute period on upper extremity motor recovery.
Population: Stroke survivors. Study duration: 6 months. Study protocol: Participants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks. They will be monitored pre and post training, and 6 months post-stroke. Outcome measures will include clinical, kinematic and adherence measures (see complete list in the protocol).
- Conditions
- Stroke, Hemiplegia and Hemiparesis
- Being tested
- High dosage, high intensity motor rehabilitation
- Keywords
- Stroke Rehabilitation, Motor Impairment, Post-stroke High Dosage Rehab, Technological Rehab Post Stroke, Stroke Kinematics
- Medical subject headings
- Stroke, Hemiplegia, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dosage, high intensity motor rehabilitationBehavioural
Participants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| This group will be provided with additional rehab time during the sub actue phase. | Experimental | Participants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks.
The program will be tailored to their impairment level, and will be added to the usual treatment given during hospitalization. Receives: Behavioral: High dosage, high intensity motor rehabilitation |
| Matched group from an ongoing project with identical criteria. | No intervention | This group is comprised of patients with similar characteristics and the intervention group will be compared to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer upper extremity assessment (FM-UE)
The Upper Extremity Fugl-Meyer Assessment (UE-FMA) is a standardized clinical tool designed to evaluate motor impairment in the upper limb following a stroke. It is part of the broader Fugl-Meyer Assessment, one of the most widely used and validated scales in stroke rehabilitation research. The UE-FMA specifically assesses movement, coordination, and reflexes in the shoulder, elbow, forearm, wrist, and hand, with a maximum score of 66 points. The scale is divided into subcomponents, including upper limb movement (36 points), wrist (10 points), hand (14 points), and coordination/speed (6 points). Each item is scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), offering a total score that reflects the level of motor impairment-higher scores indicate better motor function. The UE-FMA is valued for its reliability, sensitivity to impairment (rather than function), and its ability to track motor recovery over time.
Measured: Enrollment, 1 month, 3 months, 6 months after enrollment
Action research arm test (ARAT)
The Action Research Arm Test (ARAT) is a standardized clinical tool used to assess upper limb function following stroke or neurological injury, with a focus on evaluating the ability to perform purposeful, goal-directed tasks. It consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement, each designed to measure different aspects of upper limb activity. Tasks include actions such as picking up small blocks, pouring water, or moving objects across a table. Each item is scored on a 4-point ordinal scale ranging from 0 (no movement) to 3 (normal performance), yielding a maximum total score of 57. The ARAT captures the functional use of the hand and arm in a way that reflects real-world tasks, making it especially relevant for tracking meaningful improvements during rehabilitation. It is known for its high inter-rater and intra-rater reliability and is sensitive to changes in functional performance across a wide spectrum of impairment levels.
Measured: Enrollment, 1 month, 3 months, 6 months after enrollment
Stroke Impact Scale (SIS) hand domain, version 2.0
The Stroke Impact Scale (SIS) hand domain, version 2.0, is a patient-reported outcome measure that assesses the perceived difficulty of using the affected hand in everyday tasks following a stroke. This domain includes five items that ask individuals to rate the difficulty of performing common activities such as carrying heavy objects, turning a doorknob, or picking up a coin. Each item is scored on a 5-point Likert scale ranging from 1 (could not do it at all) to 5 (not difficult at all), reflecting the patient's experience over the past week. Scores are converted to a 0-100 scale, with higher scores indicating better perceived hand function. The SIS hand domain captures the individual's perspective on the functional impact of stroke on daily activities, providing valuable insight into real-world hand use. It is frequently used in stroke rehabilitation studies to complement performance-based assessments and to evaluate patient-centered outcomes.
Measured: Enrollment, 1 month, 3 months, 6 months after enrollment
Kinematics
Using reaching tasks that will be recorded using multiple high resolution video-cameras and analyzed using AI algorithm (OpenPose). Outcome measures that will be examined include: trajectory smoothness, reaching extent, shoulder-elbow synergy, movement time and deviation from trajectories of age matched healthy controls.
Measured: Enrollment, 1 month, 3 months, 6 months
Secondary outcomes (6)
Upper extremity activity
Daily natural activity will be monitored for using IMUs (Movella DOT) worn on upper extremity and trunk for periods of up-to 6 hours.
Measured: Enrollment and 3 months.
Time on task
Actual time spent training during a practice session.
Measured: The measure will be recorded every single practice session, twice a day, 5 days a week. Total Time on Task will be calculated at the end of the intervention period, approximately 4 weeks.
Attendance
The rate in which a participant actively participated in the training sessions.
Measured: The measure will be recorded every single practice session, twice a day, 5 days a week. Total attendance will be calculated at the end of the intervention period, approximately after 4 weeks.
Visual Analogue Scale for pain
The VAS is a self-report measure consisting of a 10 centimeter line with a statement at each end representing one extreme of pain intensity (No pain and pain as bad as it could possibly be). The participant gives their indication with a pen mark on the line corresponding to their present pain level. The higher the score, the worse the pain.
Measured: The measure will be recorded before and after every single practice session, twice a day, 5 days a week. The mean pain level delta will be calculated at the end of the intervention period, approximately 4 weeks.
Rating of perceived exertion (RPE)
The revised category-ratio scale (0 to 10 scale) will be used to monitor and guide exercise intensity. Participants subjectively rate their level of exertion during exercise (American College of Sports Medicine, 2010). A higher score means higher exertion experienced by the participant during the session.
It is not necessarily good or bad, it is just an indication of the effort.
Measured: The measure will be recorded every single practice session, twice a day, 5 days a week.
The Intrinsic Motivation Inventory (IMI)
The IMI is a validated self-report tool used to assess intrinsic motivation toward a specific activity. It includes multiple subscales, with Interest/Enjoyment considered the primary indicator of intrinsic motivation. Items are rated on a 7-point Likert scale (1 = not at all true, 7 = very true), and subscale scores are averaged to produce interpretable values. Higher scores reflect greater intrinsic motivation, perceived competence, or effort, depending on the subscale.
Measured: At the end of the intervention period for each participant (i.e. 4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start13 Jul 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group will be compared to a matched historical cohort, that will be added to in parallel during recruitment.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adi Negev-Nahalat Eran
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Sponsor
- Investigators
- Lior Shmuelof, Prof., Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056049
- Sponsor's protocol ID
- NGV-24-0006
- Acronym
- EFODIN
- Status last verified
- Jul 2025
- First submitted
- 10 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data to be shared will include de-identified information collected during the trial, such as demographic and baseline characteristics, intervention allocations, and all outcome measures used in both the primary and secondary analyses. In addition, supporting documentation will be provided to facilitate proper use of the data, including the study protocol, statistical analysis plan, informed consent form template, and a comprehensive data dictionary.
Publications
Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.
PubMed 20813995Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.
PubMed 12907818Buch ER, Rizk S, Nicolo P, Cohen LG, Schnider A, Guggisberg AG. Predicting motor improvement after stroke with clinical assessment and diffusion tensor imaging. Neurology. 2016 May 17;86(20):1924-5. doi: 10.1212/WNL.0000000000002675. Epub 2016 Apr 29. No abstract available.
PubMed 27164664Biernaskie J, Chernenko G, Corbett D. Efficacy of rehabilitative experience declines with time after focal ischemic brain injury. J Neurosci. 2004 Feb 4;24(5):1245-54. doi: 10.1523/JNEUROSCI.3834-03.2004.
PubMed 14762143
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High-dosage, High-intensity Rehabilitation Program on the Motor Recovery After Stroke in Subacute Patients
- ClinicalTrials.gov ID
- NCT07056049
- Acronym / sponsor ID
- EFODIN / NGV-24-0006
- Conditions
- Stroke, Hemiplegia and Hemiparesis
- Keywords
- Stroke Rehabilitation, Motor Impairment, Post-stroke High Dosage Rehab, Technological Rehab Post Stroke, Stroke Kinematics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Adi Negev-Nahalat EranUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- 13 Jul 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 9 Jul 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.
Intervention abstract
Background: Stroke is the leading cause of long-term disability, and the second leading cause of death in the western world. Most stroke survivors will suffer from motor and cognitive disturbances for the rest of their life, which negatively affects their normal daily life.
Despite the decline in stroke-related mortality over the past decades, the outcome of rehabilitation programs does not improve, and is predictable regardless of the program used. Still, several human and animal studies show that high capacity of training in the early stages post stroke improve motor recovery. This notion is far from being well established.
Aim: Studying the effect of high-dosage, high-intensity training program in the subacute period on upper extremity motor recovery.
Population: Stroke survivors. Study duration: 6 months. Study protocol: Participants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks. They will be monitored pre and post training, and 6 months post-stroke. Outcome measures will include clinical, kinematic and adherence measures (see complete list in the protocol).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention group will be compared to a matched historical cohort, that will be added to in parallel during recruitment.
| Arm | Type | Receives |
|---|---|---|
| This group will be provided with additional rehab time during the sub actue phase. | Experimental | Behavioral: High dosage, high intensity motor rehabilitationParticipants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks. The program will be tailored to their impairment level, and will be added to the usual treatment given during hospitalization. |
| Matched group from an ongoing project with identical criteria. | No intervention | –This group is comprised of patients with similar characteristics and the intervention group will be compared to this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Ischemic or hemorrhagic stroke (hemispheric or brainstem) confirmed by CT or MRI
- First-ever stroke or previous stroke with no upper extremity weakness
- 1 week ≤ Time after stroke onset ≤ 6 weeks
- Active shoulder flexion of at least 20◦ and partial wrist and/or finger active movement
Key exclusion criteria (3 listed)
- A painful shoulder limiting an active forward reach
- Severe spasticity or non-neural loss of range of motion
- Cognitive or communication impairments as determined by the clinical team Unstable medical conditions
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 |
|---|---|---|
| High dosage, high intensity motor rehabilitationParticipants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks. | Behavioural | This group will be provided with additional rehab time during the sub actue phase. |
Primary outcome
Fugl-Meyer upper extremity assessment (FM-UE)
Time frame: Enrollment, 1 month, 3 months, 6 months after enrollment
The Upper Extremity Fugl-Meyer Assessment (UE-FMA) is a standardized clinical tool designed to evaluate motor impairment in the upper limb following a stroke. It is part of the broader Fugl-Meyer Assessment, one of the most widely used and validated scales in stroke rehabilitation research. The UE-FMA specifically assesses movement, coordination, and reflexes in the shoulder, elbow, forearm, wrist, and hand, with a maximum score of 66 points. The scale is divided into subcomponents, including upper limb movement (36 points), wrist (10 points), hand (14 points), and coordination/speed (6 points). Each item is scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), offering a total score that reflects the level of motor impairment-higher scores indicate better motor function. The UE-FMA is valued for its reliability, sensitivity to impairment (rather than function), and its ability to track motor recovery over time.
Action research arm test (ARAT)
Time frame: Enrollment, 1 month, 3 months, 6 months after enrollment
The Action Research Arm Test (ARAT) is a standardized clinical tool used to assess upper limb function following stroke or neurological injury, with a focus on evaluating the ability to perform purposeful, goal-directed tasks. It consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement, each designed to measure different aspects of upper limb activity. Tasks include actions such as picking up small blocks, pouring water, or moving objects across a table. Each item is scored on a 4-point ordinal scale ranging from 0 (no movement) to 3 (normal performance), yielding a maximum total score of 57. The ARAT captures the functional use of the hand and arm in a way that reflects real-world tasks, making it especially relevant for tracking meaningful improvements during rehabilitation. It is known for its high inter-rater and intra-rater reliability and is sensitive to changes in functional performance across a wide spectrum of impairment levels.
Stroke Impact Scale (SIS) hand domain, version 2.0
Time frame: Enrollment, 1 month, 3 months, 6 months after enrollment
The Stroke Impact Scale (SIS) hand domain, version 2.0, is a patient-reported outcome measure that assesses the perceived difficulty of using the affected hand in everyday tasks following a stroke. This domain includes five items that ask individuals to rate the difficulty of performing common activities such as carrying heavy objects, turning a doorknob, or picking up a coin. Each item is scored on a 5-point Likert scale ranging from 1 (could not do it at all) to 5 (not difficult at all), reflecting the patient's experience over the past week. Scores are converted to a 0-100 scale, with higher scores indicating better perceived hand function. The SIS hand domain captures the individual's perspective on the functional impact of stroke on daily activities, providing valuable insight into real-world hand use. It is frequently used in stroke rehabilitation studies to complement performance-based assessments and to evaluate patient-centered outcomes.
Kinematics
Time frame: Enrollment, 1 month, 3 months, 6 months
Using reaching tasks that will be recorded using multiple high resolution video-cameras and analyzed using AI algorithm (OpenPose). Outcome measures that will be examined include: trajectory smoothness, reaching extent, shoulder-elbow synergy, movement time and deviation from trajectories of age matched healthy controls.
6 secondary outcomes
Upper extremity activity
Time frame: Enrollment and 3 months.
Time on task
Time frame: The measure will be recorded every single practice session, twice a day, 5 days a week. Total Time on Task will be calculated at the end of the intervention period, approximately 4 weeks.
Attendance
Time frame: The measure will be recorded every single practice session, twice a day, 5 days a week. Total attendance will be calculated at the end of the intervention period, approximately after 4 weeks.
Visual Analogue Scale for pain
Time frame: The measure will be recorded before and after every single practice session, twice a day, 5 days a week. The mean pain level delta will be calculated at the end of the intervention period, approximately 4 weeks.
Rating of perceived exertion (RPE)
Time frame: The measure will be recorded every single practice session, twice a day, 5 days a week.
The Intrinsic Motivation Inventory (IMI)
Time frame: At the end of the intervention period for each participant (i.e. 4 weeks).
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 17 Jul 2025.
- Background: PubMed 20813995Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.
- Background: PubMed 12907818Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.
- Background: PubMed 27164664Buch ER, Rizk S, Nicolo P, Cohen LG, Schnider A, Guggisberg AG. Predicting motor improvement after stroke with clinical assessment and diffusion tensor imaging. Neurology. 2016 May 17;86(20):1924-5. doi: 10.1212/WNL.0000000000002675. Epub 2016 Apr 29. No abstract available.
- Background: PubMed 14762143Biernaskie J, Chernenko G, Corbett D. Efficacy of rehabilitative experience declines with time after focal ischemic brain injury. J Neurosci. 2004 Feb 4;24(5):1245-54. doi: 10.1523/JNEUROSCI.3834-03.2004.
- Individual participant dataSharing planned: Yes. The individual participant data to be shared will include de-identified information collected during the trial, such as demographic and baseline characteristics, intervention allocations, and all outcome measures used in both the primary and secondary analyses. In addition, supporting documentation will be provided to facilitate proper use of the data, including the study protocol, statistical analysis plan, informed consent form template, and a comprehensive data dictionary.
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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.
Lior Shmuelof, Prof. principal investigator
Ben-Gurion University of the Negev
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dosage, high intensity motor rehabilitation in people with Stroke and Hemiplegia and Hemiparesis, run by Adi Negev-Nahalat Eran at 2 sites in Israel.
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 6 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: looking for participants now, as of the sponsor's last update on 17 Jul 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 Israel. 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 Gil Meir (+972 0548340307, gilmeir10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer upper extremity assessment (FM-UE) (time frame: Enrollment, 1 month, 3 months, 6 months after enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07056049, which also lists 4 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 17 Jul 2025.