Epilepsy in ChildrenISEPEENCT06271785
Prognostic Value of High-resolution Electrical Source Imaging on the Success of Pediatric Focal Epilepsy Surgery
A study testing HR-EEG recording in people with Epilepsy in Children, run by University Hospital, Angers at 9 sites in France.
Trial summary
This study investigates the usefulness of high resolution electrical source imaging (HR-ESI) in the setting of presurgical evaluation of drug-resistant focal epilepsy in children. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Epilepsy in Children
- What is being tested?
- HR-EEG recording
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 9 sitesFrance
- Study dates
- 15 May 2024to 15 Nov 2026
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age≥2 and <17 years;
- Drug-resistant focal epilepsy (failure of at least 2 well-conducted drug trials);
- Phase 1 pre-op evaluation with scalp video-EEG recording, MRI and PET-FDG suggesting that the patient could be a good candidate for epilepsy surgery;
- Recent scalp EEG record (within 12 months) showing the presence of interictal spikes;
- High-quality and recent (within 6 months) structural MRI with 3D-T1 sequences covering the whole brain and the scalp available.
Who cannot join
- Behavioral deficits making recording of scalp EEG impossible without sedation;
- Informed consent form not signed by the parents;
- Patient not affiliated to a social security system
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
Angers university hospital, Pédiatric department
Angers, 49000
Patrick Van Bogaert, Professor, 02 41 35 48 46, Patrick.VanBogaert@chu-angers.fr
- Not yet recruiting
Lille University Hospital, Clinical Neurophysiology Department
Lille, 59000
Philippe DERAMBURE, Professor, 03 20 44 63 62, Philippe.DERAMBURE@CHRU-LILLE.FR
- Not yet recruiting
Civil Hospices of Lyon, Functional Neurology Department
Lyon, 69677
Julien Jung, Doctor, 04 72 35 79 00, julien.jung@chu-lyon.fr
- Not yet recruiting
Marseille Timone University Hospital, Epileptology and Cerebral Rhythmology Department
Marseille, 13000
Fabrice BARTOLOMEI, Professor, 04 91 38 46 84, Fabrice.BARTOLOMEI@ap-hm.fr
- Not yet recruiting
Nancy University Hospital, Neurology Department
Nancy, 54000
Louis Maillard, Professor, 03 83 85 16 09, l.maillard@chru-nancy.fr
- Not yet recruiting
Paris Neck University Hospital, Pediatric department
Paris, 75015
Anna Kaminska, Doctor, 01 44 49 51 85, anna.kaminska@aphp.fr
- Not yet recruiting
Paris Robert-Debré University Hospital, Department of Physiology, Pediatric functional explorations
Paris, 75019
François-Xavier MAUVAIS, Doctor, 01 40 03 20 00, francois-xavier.mauvais@aphp.fr
- Not yet recruiting
Rothschild Ophtalmologic Fondation, Pediatric neurosurgery Department
Paris, 75019
Emmanuel Raffo, Professor, 01 48 03 68 17, eraffo@for.paris
- Not yet recruiting
Rennes University Hospital, Pediatric department
Rennes, 35000
Silvia Adriana NAPURI PEIRANO, Doctor, 02 99 26 58 34, Silviaadriana.NAPURI.PEIRANO@chu-rennes.fr
About this study
Official title: ISEPEE : Prognostic Value of High-resolution Electrical Source Imaging on the Success of Pediatric Focal Epilepsy Surgery
This study investigates the usefulness of high resolution electrical source imaging (HR-ESI) in the setting of presurgical evaluation of drug-resistant focal epilepsy in children.
This method is based on an estimation of the intra-cerebral source that produces a signal recorded by scalp electrodes by solving the inverse problem, taking into account attenuation factors resulting from particular conductivity properties of the cerebral, peri-cerebral and cranial tissues.
Read more
Electrical sources are then fused on structural magnetic resonance imaging (MRI).
Scalp EEG recorded using 64 to 256 electrodes refers to as high resolution EEG (HR-EEG), leading to HR-ESI.
Studies based on small population of children or on mixt population of children and adults showed that HR-ESI has accuracy values, i.e. percentage of true positives (electrical source localized in the brain area resected and success of surgery) and true negatives (electrical source localized outside the brain area resected and failure of surgery) among the total population, ranging from 50 to 80%.
Discrepancies between studies could be explained by the limited number of patients included or by the mixture of pediatric and adult data.
Another limitation of previously published studies is that the spatial pattern of dipole source distribution was not taken into account to determine prediction accuracy of ESI.
Studies using magnetoencephalography (MEG) to perform magnetic source imaging (MSI) suggest that the spatial pattern of dipole source distribution needs to be considered, a spatially-restricted dipole distribution being associated with better post-surgical outcome when resected.
To tackle these issues, the investigators aim to conduct the first large prospective multicentric study in children with focal epilepsy candidates to surgery to assess prediction accuracy of ESI based on the finding of tight clusters of dipoles.
This is original as this pattern (tight versus loose cluster of dipoles) has been studied by several researchers using MEG but not using HR-EEG.
The investigators make the hypothesis that HR-EEG will allow to identity good candidates for epilepsy surgery and thus to offer this underutilized treatment in more children with better post-surgical outcome.
Among the secondary objectives, the investigators will address methodological issues related to the resolution of the inverse problem (methods using distributed sources models versus methods based on equivalent dipole estimation), the potential added value to model high-frequency oscillations (HFO), and the investigators will assess the cost-utility of the HR-ESI procedure.
Read the detailed description
This study investigates the usefulness of high resolution electrical source imaging (HR-ESI) in the setting of presurgical evaluation of drug-resistant focal epilepsy in children.
This method is based on an estimation of the intra-cerebral source that produces a signal recorded by scalp electrodes by solving the inverse problem, taking into account attenuation factors resulting from particular conductivity properties of the cerebral, peri-cerebral and cranial tissues.
Electrical sources are then fused on structural magnetic resonance imaging (MRI).
Scalp EEG recorded using 64 to 256 electrodes refers to as high resolution EEG (HR-EEG), leading to HR-ESI.
Studies based on small population of children or on mixt population of children and adults showed that HR-ESI has accuracy values, i.e. percentage of true positives (electrical source localized in the brain area resected and success of surgery) and true negatives (electrical source localized outside the brain area resected and failure of surgery) among the total population, ranging from 50 to 80%.
Discrepancies between studies could be explained by the limited number of patients included or by the mixture of pediatric and adult data.
Another limitation of previously published studies is that the spatial pattern of dipole source distribution was not taken into account to determine prediction accuracy of ESI.
Studies using magnetoencephalography (MEG) to perform magnetic source imaging (MSI) suggest that the spatial pattern of dipole source distribution needs to be considered, a spatially-restricted dipole distribution being associated with better post-surgical outcome when resected.
To tackle these issues, the investigators aim to conduct the first large prospective multicentric study in children with focal epilepsy candidates to surgery to assess prediction accuracy of ESI based on the finding of tight clusters of dipoles.
This is original as this pattern (tight versus loose cluster of dipoles) has been studied by several researchers using MEG but not using HR-EEG.
The investigators make the hypothesis that HR-EEG will allow to identity good candidates for epilepsy surgery and thus to offer this underutilized treatment in more children with better post-surgical outcome.
Among the secondary objectives, the investigators will address methodological issues related to the resolution of the inverse problem (methods using distributed sources models versus methods based on equivalent dipole estimation), the potential added value to model high-frequency oscillations (HFO), and the investigators will assess the cost-utility of the HR-ESI procedure.
The study focuses on epileptic children who are candidates to a procedure of epilepsy surgery aiming to make them seizure-free. The principle of epilepsy surgery is to remove the brain area that generates patient's seizures, i.e. the seizure onset zone (SOZ). Candidates are patients with focal seizures that do not completely respond to the medical treatment and impact their quality of life. This represents 5-10% of epileptic children. Pre-surgical evaluation of these patients consists to perform in a first step non-invasive methods aimed to localize the SOZ: video-EEG in order to characterize usual seizures of the patient and to record and localize interictal epileptiform discharges (IED), MRI to search for a structural epileptogenic lesion, and positron emission tomography (PET) with fluorodeoxyglucose (FDG) to search for a brain area showing abnormal FDG uptake. After this so-called phase 1 work-up, the case is discussed in a multidisciplinary meeting, resulting in one of the 3 following decisions: (1) surgical resection when information from phase 1 is considered as sufficient, (2) continuation of the surgical process by performing a phase 2 evaluation, i.e. an invasive EEG recording using intracranial electrodes implanted by stereotaxy (SEEG), when information from phase 1 is considered as insufficient but made possible to pose a hypothesis regarding the localization of the SOZ, and (3) rejection for surgery. In children, epilepsy makes patient seizure-free in 60-80% of the cases. HR-ESI is a relatively new method that has been developed to localize non-invasively the SOZ with the hope to decrease the number of patients rejected for surgery or oriented to phase 2, and to increase the rate of success of epilepsy surgery.
- Conditions
- Epilepsy in Children
- Being tested
- HR-EEG recording
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR-EEG recordingDiagnostic test
All participants will have a HR-EEG recordings. It will be made at rest. Nap-like sleep is encouraged, but no sedatives will be given. Recording time will not exceed two hours.
| Study group | Role | What they receive |
|---|---|---|
| HR-EEG recording | Experimental | Not described Receives: Diagnostic Test: HR-EEG recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction accuracy index
The main outcome is the prediction accuracy index, as assessed in fusing pre-op current equivalent dipoles to postop MRI, based on a tight cluster of spikes compared to the prediction accuracy index based on a loose cluster of spikes or on multiple clusters of spikes.
Measured: 24 months
Secondary outcomes (6)
Localization of the epileptogenic zone (Baseline)
To assess the ability of HR-ESI to localize the epileptogenic zone. Spatial congruence between the brain areas involved by the sources of interictal spikes and the epileptogenic zone, defined by either a MRI lesion concordant with the electroclinical data, or the brain area resected in patients who achieved good outcome following surgery.
Measured: Baseline
Localization of the epileptogenic zone (After Surgery)
To assess the ability of HR-ESI to localize the epileptogenic zone. Spatial congruence between the brain areas involved by the sources of interictal spikes and the epileptogenic zone, defined by either a MRI lesion concordant with the electroclinical data, or the brain area resected in patients who achieved good outcome following surgery.
Measured: 24 months (= V3)
preoperative accuracy of epileptogenic source localization
To determine the preoperative accuracy of epileptogenic source localization delineated by HR-ESI.
Spatial congruence between the brain areas involved by the sources of interictal spikes and the SOZ as assessed by intracranial EEG in patients oriented to intracranial EEG investigation.
Measured: 12 months (= V2)
prognostic value of HFO
To determine the prognostic value of epileptogenic source localization delineated by HR-ESI based on high-frequency oscillations (HFO), on successful epilepsy surgery.
Prediction accuracy index, as assessed in fusing pre-op current equivalent dipoles to postop MRI, based on of a unique, well delineated and completely resected cluster of HFO, compared to other situations.
Measured: 24 months (= V3)
Impact of method of sources reconstruction, conditions of EEG recordings and sampling rate
To study the influence of some factors that could impact results of HR-ESI: type of method of sources reconstruction, conditions of EEG recordings (awake state versus sleep), and sampling rate.
Congruence of the brain areas identified by HR-ESI according to the methods of sources reconstruction, the type of spikes (awake versus sleep) and the sampling rate.
Measured: 3 months (= V1)
health-economic modeling
To perform a health-economic modeling to assess cost-utility and cost-effectiveness of the HR-ESI procedure. Evolution of Quality of life assessed with Child Health Utility 9 Dimensions (CHU9D) questionnaire
Measured: 24 months (= V3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start15 May 2024
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy in ChildrenStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271785
- Sponsor's protocol ID
- 49RC22_0354
- Acronym
- ISEPEE
- Status last verified
- Sep 2025
- First submitted
- 14 Feb 2024
- Last updated
- 19 Sep 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 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ISEPEE : Prognostic Value of High-resolution Electrical Source Imaging on the Success of Pediatric Focal Epilepsy Surgery
- ClinicalTrials.gov ID
- NCT06271785
- Acronym / sponsor ID
- ISEPEE / 49RC22_0354
- Conditions
- Epilepsy in Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the usefulness of high resolution electrical source imaging (HR-ESI) in the setting of presurgical evaluation of drug-resistant focal epilepsy in children.
This method is based on an estimation of the intra-cerebral source that produces a signal recorded by scalp electrodes by solving the inverse problem, taking into account attenuation factors resulting from particular conductivity properties of the cerebral, peri-cerebral and cranial tissues.
Electrical sources are then fused on structural magnetic resonance imaging (MRI).
Scalp EEG recorded using 64 to 256 electrodes refers to as high resolution EEG (HR-EEG), leading to HR-ESI.
Studies based on small population of children or on mixt population of children and adults showed that HR-ESI has accuracy values, i.e. percentage of true positives (electrical source localized in the brain area resected and success of surgery) and true negatives (electrical source localized outside the brain area resected and failure of surgery) among the total population, ranging from 50 to 80%.
Discrepancies between studies could be explained by the limited number of patients included or by the mixture of pediatric and adult data.
Another limitation of previously published studies is that the spatial pattern of dipole source distribution was not taken into account to determine prediction accuracy of ESI.
Studies using magnetoencephalography (MEG) to perform magnetic source imaging (MSI) suggest that the spatial pattern of dipole source distribution needs to be considered, a spatially-restricted dipole distribution being associated with better post-surgical outcome when resected.
To tackle these issues, the investigators aim to conduct the first large prospective multicentric study in children with focal epilepsy candidates to surgery to assess prediction accuracy of ESI based on the finding of tight clusters of dipoles.
This is original as this pattern (tight versus loose cluster of dipoles) has been studied by several researchers using MEG but not using HR-EEG.
The investigators make the hypothesis that HR-EEG will allow to identity good candidates for epilepsy surgery and thus to offer this underutilized treatment in more children with better post-surgical outcome.
Among the secondary objectives, the investigators will address methodological issues related to the resolution of the inverse problem (methods using distributed sources models versus methods based on equivalent dipole estimation), the potential added value to model high-frequency oscillations (HFO), and the investigators will assess the cost-utility of the HR-ESI procedure.
Detailed description
This study investigates the usefulness of high resolution electrical source imaging (HR-ESI) in the setting of presurgical evaluation of drug-resistant focal epilepsy in children.
This method is based on an estimation of the intra-cerebral source that produces a signal recorded by scalp electrodes by solving the inverse problem, taking into account attenuation factors resulting from particular conductivity properties of the cerebral, peri-cerebral and cranial tissues.
Electrical sources are then fused on structural magnetic resonance imaging (MRI).
Scalp EEG recorded using 64 to 256 electrodes refers to as high resolution EEG (HR-EEG), leading to HR-ESI.
Studies based on small population of children or on mixt population of children and adults showed that HR-ESI has accuracy values, i.e. percentage of true positives (electrical source localized in the brain area resected and success of surgery) and true negatives (electrical source localized outside the brain area resected and failure of surgery) among the total population, ranging from 50 to 80%.
Discrepancies between studies could be explained by the limited number of patients included or by the mixture of pediatric and adult data.
Another limitation of previously published studies is that the spatial pattern of dipole source distribution was not taken into account to determine prediction accuracy of ESI.
Studies using magnetoencephalography (MEG) to perform magnetic source imaging (MSI) suggest that the spatial pattern of dipole source distribution needs to be considered, a spatially-restricted dipole distribution being associated with better post-surgical outcome when resected.
To tackle these issues, the investigators aim to conduct the first large prospective multicentric study in children with focal epilepsy candidates to surgery to assess prediction accuracy of ESI based on the finding of tight clusters of dipoles.
This is original as this pattern (tight versus loose cluster of dipoles) has been studied by several researchers using MEG but not using HR-EEG.
The investigators make the hypothesis that HR-EEG will allow to identity good candidates for epilepsy surgery and thus to offer this underutilized treatment in more children with better post-surgical outcome.
Among the secondary objectives, the investigators will address methodological issues related to the resolution of the inverse problem (methods using distributed sources models versus methods based on equivalent dipole estimation), the potential added value to model high-frequency oscillations (HFO), and the investigators will assess the cost-utility of the HR-ESI procedure.
The study focuses on epileptic children who are candidates to a procedure of epilepsy surgery aiming to make them seizure-free. The principle of epilepsy surgery is to remove the brain area that generates patient's seizures, i.e. the seizure onset zone (SOZ). Candidates are patients with focal seizures that do not completely respond to the medical treatment and impact their quality of life. This represents 5-10% of epileptic children. Pre-surgical evaluation of these patients consists to perform in a first step non-invasive methods aimed to localize the SOZ: video-EEG in order to characterize usual seizures of the patient and to record and localize interictal epileptiform discharges (IED), MRI to search for a structural epileptogenic lesion, and positron emission tomography (PET) with fluorodeoxyglucose (FDG) to search for a brain area showing abnormal FDG uptake. After this so-called phase 1 work-up, the case is discussed in a multidisciplinary meeting, resulting in one of the 3 following decisions: (1) surgical resection when information from phase 1 is considered as sufficient, (2) continuation of the surgical process by performing a phase 2 evaluation, i.e. an invasive EEG recording using intracranial electrodes implanted by stereotaxy (SEEG), when information from phase 1 is considered as insufficient but made possible to pose a hypothesis regarding the localization of the SOZ, and (3) rejection for surgery. In children, epilepsy makes patient seizure-free in 60-80% of the cases. HR-ESI is a relatively new method that has been developed to localize non-invasively the SOZ with the hope to decrease the number of patients rejected for surgery or oriented to phase 2, and to increase the rate of success of epilepsy surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HR-EEG recording | Experimental | Diagnostic Test: HR-EEG recording |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age≥2 and <17 years;
- Drug-resistant focal epilepsy (failure of at least 2 well-conducted drug trials);
- Phase 1 pre-op evaluation with scalp video-EEG recording, MRI and PET-FDG suggesting that the patient could be a good candidate for epilepsy surgery;
- Recent scalp EEG record (within 12 months) showing the presence of interictal spikes;
- High-quality and recent (within 6 months) structural MRI with 3D-T1 sequences covering the whole brain and the scalp available.
Key exclusion criteria (3 listed)
- Behavioral deficits making recording of scalp EEG impossible without sedation;
- Informed consent form not signed by the parents;
- Patient not affiliated to a social security system
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 |
|---|---|---|
| HR-EEG recordingAll participants will have a HR-EEG recordings. It will be made at rest. Nap-like sleep is encouraged, but no sedatives will be given. Recording time will not exceed two hours. | Diagnostic test | HR-EEG recording |
Primary outcome
Prediction accuracy index
Time frame: 24 months
The main outcome is the prediction accuracy index, as assessed in fusing pre-op current equivalent dipoles to postop MRI, based on a tight cluster of spikes compared to the prediction accuracy index based on a loose cluster of spikes or on multiple clusters of spikes.
6 secondary outcomes
Localization of the epileptogenic zone (Baseline)
Time frame: Baseline
Localization of the epileptogenic zone (After Surgery)
Time frame: 24 months (= V3)
preoperative accuracy of epileptogenic source localization
Time frame: 12 months (= V2)
prognostic value of HFO
Time frame: 24 months (= V3)
Impact of method of sources reconstruction, conditions of EEG recordings and sampling rate
Time frame: 3 months (= V1)
health-economic modeling
Time frame: 24 months (= V3)
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 19 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Epilepsy in Children
RecruitingPhase 3
A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
Dravet Syndrome
RecruitingObservational study
Long-Term Epilepsy Outcomes in Children With a History of Perinatal Stroke
Perinatal Stroke, Epilepsy
Active, not recruitingPhase 3
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
Dravet Syndrome
RecruitingPhase 1/2
A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome
Dravet Syndrome
Not yet recruitingObservational study
Antiseizure Medications and CBC in Children With Epilepsy
Epilepsy
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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HR-EEG recording in people with Epilepsy in Children, run by University Hospital, Angers at 9 sites in France.
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 5 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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 Patrick Van Bogaert, Professor (+33 2 41 35 48 46, Patrick.VanBogaert@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction accuracy index (time frame: 24 months). 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 19 Sep 2025.