Hypoxic Brain DamageGEN-HOPENCT07264166
Intranasal AAV9-PHP.eB Gene Therapy in Cerebral Palsy (CP) & Hypoxic Ischemic Encephalopathy (HIE)
An observational study of Hypoxic Brain Damage and Hypoxic Ischaemic Encephalopathy (HIE), run by Healing Hope International at 1 site in Mexico.
Trial summary
This international study, organized by Healing Hope International, is an observational registry designed to collect real-world data on participants living with chronic hypoxic ischemic encephalopathy (HIE) who receive an emerging intranasal gene therapy based on the AAV9-PHP.eB viral vector. Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Hypoxic Brain Damage, Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischaemic Encephalopathy Due to Cardiac Arrest
- How many people
- 25 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2026to 15 Jun 2032
- 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 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of patients aged 2 to 60 years with chronic hypoxic-ischemic encephalopathy (HIE) who have undergone or are undergoing intranasal 15-gene AAV9-PHP.eB gene therapy at participating international clinical sites. Participants typically present with moderate to severe motor and cognitive impairments resulting from neonatal brain injury. Most rely on rehabilitative therapies such as occupational, physical, or speech therapy, and many have comorbid spasticity, seizure disorders, or feeding and respiratory challenges. Families voluntarily enroll to share functional, cognitive, imaging, and quality-of-life outcomes following the therapy, allowing the registry to capture real-world data from diverse treatment centers. Enrollment is open to patients meeting medical stability criteria and caregiver consent requirements, regardless of geographic origin, socioeconomic background, or previous therapy history. No healthy volunteers are included.
Who may be able to join
- Age 2 to 65 years, at the time of enrollment.
- Documented diagnosis of chronic hypoxic-ischemic encephalopathy (HIE), confirmed by medical history, MRI findings, or neonatal records.
- Stable medical condition for at least 6 months prior to enrollment (no major surgeries or hospitalizations related to HIE within that period).
- Baseline Gross Motor Function Measure (GMFM-66 or GMFM-88) score between 40% and 70%, representing moderate functional impairment.
- Completion or active receipt of intranasal 15-gene AAV9-PHP.eB therapy at a participating international clinical site under local physician supervision.
- Parent(s) or legal guardian(s) willing and able to provide written informed consent for participation in the observational registry and data sharing.
- Access to clinical follow-up and ability to participate in scheduled assessments or data submissions at 3, 6, 12, 18, and 24 months after treatment.
Who cannot join
- Active systemic infection, immune deficiency, or ongoing use of immunosuppressive agents (other than short-term rapamycin used per treating physician's protocol).
- Known positive anti-AAV9 neutralizing antibody titer at baseline exceeding threshold values that may preclude effective vector transduction (if testing performed locally).
- Uncontrolled seizure activity exceeding five episodes per day at baseline despite medical therapy.
- Known or suspected malignancy, severe hepatic or renal dysfunction, or other conditions that would confound safety monitoring.
- Previous gene therapy or investigational stem cell therapy within the past 12 months.
- Known pregnancy or breastfeeding in post-pubertal female participants.
- Any condition that, in the opinion of the local investigator or registry sponsor, may interfere with participation, data reliability, or patient safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Healing Hope International Multinational Observational Registry Evaluating Intranasal 15-Gene AAV9-PHP.eB Therapy and Functional Outcomes in Participants With Cerebral Palsy & Chronic Hypoxic-Ischemic Encephalopathy (HIE) (GEN-HOPE Study)
This international study, organized by Healing Hope International, is an observational registry designed to collect real-world data on participants living with chronic hypoxic ischemic encephalopathy (HIE) who receive an emerging intranasal gene therapy based on the AAV9-PHP.eB viral vector.
The investigational therapy delivers a panel of 15 restorative genes that support brain repair, reduce inflammation, promote myelination, and improve neural communication. It is administered intranasally in one or three sessions by participating international clinical teams. Because the therapy is already being offered abroad, this registry does not assign treatment but instead follows participants who have received it as part of their existing medical care.
Read more
The GEN HOPE Study aims to understand how this gene therapy affects movement, cognition, spasticity, and seizure frequency over time. Families and clinicians will share outcomes such as changes in gross motor function (GMFM-66/88), cognitive assessments (Bayley or WISC tests), and quality-of-life measures. Information on safety, laboratory results, MRI findings, and caregiver-reported experiences will also be collected.
By combining data from multiple countries, the registry seeks to evaluate whether this novel gene based approach can meaningfully improve daily function and comfort for participants with chronic HIE. Results will guide future clinical trial development and help define safe and effective standards of care for regenerative neurologic therapies.
Read the detailed description
The GEN HOPE Study is a multinational, real world observational registry coordinated by Healing Hope International to characterize reported safety events and functional outcomes in participants with chronic hypoxic ischemic encephalopathy (HIE), a condition commonly presenting as cerebral palsy, who have received intranasal 15-gene AAV9-PHP.eB gene therapy outside the United States.
This registry does not assign or direct any medical intervention. Instead, it prospectively collects standardized clinical and caregiver reported data from participating international sites where the therapy is already being used under local medical supervision. The aim is to document the naturalistic course of recovery following treatment and to generate evidence that may inform the design of future controlled trials.
The investigational therapy uses an AAV9-PHP.eB viral vector optimized for central nervous system delivery through the nasal mucosa. The 15 gene panel encodes factors related to neuronal plasticity, white matter repair, antiinflammatory modulation, metabolic and vascular support, and cellular longevity. Dosing schedules vary by site (single session or three session delivery), and some centers administer short-term rapamycin as an adjunctive immunomodulator.
Participants aged 2-65 years who have documented chronic HIE, stable baseline medical status, and caregiver consent to share outcome data. Key assessments include gross motor function (GMFM-66/88), cognitive and language evaluations (Bayley-III/IV or WISC-V), spasticity and seizure frequency, and quality-of-life and caregiver burden metrics. Whenever available, MRI/DTI data and laboratory monitoring are recorded. Follow-up intervals occur at approximately 3, 6, 12, 18, and 24 months post-treatment.
Data are analyzed using target-trial emulation and propensity-weighted methods to estimate treatment effects compared with matched external controls receiving standard care. The primary outcome is change in GMFM-66/88 score at 12 months. Secondary outcomes include cognitive performance, seizure burden, quality of life, and safety parameters.
All information is deidentified and stored in a secure international database compliant with data protection and ethical governance standards. Oversight is provided by an independent Data and Safety Monitoring Board (DSMB) with expertise in neurology, statistics, and gene-therapy safety.
The GEN HOPE Study seeks to accelerate understanding of gene based neurorestorative strategies and to establish a transparent evidence base supporting compassionate use access, long-term safety monitoring, and eventual clinical trial harmonization for participants affected by HIE worldwide.
- Conditions
- Hypoxic Brain Damage, Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischaemic Encephalopathy Due to Cardiac Arrest, Hypoxic Ischemic Encephalopathy of Newborn, Cerebral Palsy, Cerebral Palsy (CP)
- Keywords
- Hypoxic-Ischemic Encephalopathy, HIE, Cerebral Palsy, quadriplegia, hypoxic brain injury, stroke, ischemic injury, hypoxic brain damage, spastic diplegia, Chronic Hypoxic Ischemic Encephalopathy, Neonatal Hypoxic Ischemic Encephalopathy, Anoxic Brain Injury, Ischemic Brain Injury, Spastic Cerebral Palsy, Quadriplegic Cerebral Palsy, Pediatric Brain Injury, Perinatal Brain Injury, Global Cerebral Ischemia, Observational Registry, Real World Evidence
- Medical subject headings
- Hypoxia, Brain, Hypoxia-Ischemia, Brain, Cerebral Palsy, Quadriplegia, Stroke, Neurodevelopmental Disorders, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal 15-Gene AAV9-PHP.eB Therapy Cohort | This cohort includes patients diagnosed with chronic hypoxic-ischemic encephalopathy (HIE) who receive an intranasal 15-gene AAV9-PHP.eB therapy as part of their existing medical care at participating international sites. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gross Motor Function Measure (GMFM-66/88) Score From Baseline to 12 Months
Assesses change in overall motor ability using the Gross Motor Function Measure (GMFM-66/88), a validated scale for patients with cerebral palsy and/or hypoxic ischemic injury. Measures performance in lying, sitting, crawling, standing, and walking domains. Higher scores indicate greater motor function.
Measured: Baseline to 12 months after treatment
Secondary outcomes (6)
Change in Cognitive Performance (Bayley Scales) From Baseline
Assesses change in cognitive performance using the Bayley Scales of Infant and Toddler Development (Bayley-III or Bayley-IV) for participants aged 2-4 years. Composite cognitive scores range from 40-160 (mean 100, SD 15), with higher scores indicating improved cognitive and developmental function.
Measured: Baseline to 12 months and 24 months
Change in Seizure Frequency
Monthly caregiver-reported seizure logs and medication records are collected to quantify changes in seizure frequency. Reduction in seizure rate indicates improvement in neuronal stability and anti-inflammatory response. Seizure frequency is a count measure-no minimum/maximum scale required.
Measured: Baseline to 12 months and 24 months
Change in Spasticity Using the Modified Ashworth Scale (MAS)
Measures tone and resistance in major muscle groups using the Modified Ashworth Scale (0 = no increase in tone; 4 = rigid in flexion or extension). Lower scores indicate reduced spasticity.
Measured: Baseline to 12 months
Change in Quality of Life (PedsQL Caregiver-Reported Score)
Assesses child and caregiver quality of life using the Pediatric Quality of Life Inventory (PedsQL).
Scale range: 0-100, with higher scores indicating improved perceived quality of life.
Measured: Baseline to 12 months and 24 months
Change in MRI/DTI Biomarkers of White-Matter Integrity
Quantitative analysis of fractional anisotropy and mean diffusivity from diffusion tensor imaging (DTI) in periventricular and cortical regions. Increases in fractional anisotropy and cortical thickness suggest structural neurorepair.
Measured: Baseline to 12 months
Change in Cognitive Performance (WISC-V) From Baseline
Assesses change in cognitive performance using the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) for participants aged 5-10 years. Full Scale IQ scores range from 40-160, with higher scores indicating improved cognitive function.
Measured: Baseline to 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Mar 2026
- Primary completion1 Jan 2032 (estimated)
- Study completion15 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypoxic Brain DamageStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healing Hope International
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara C Tamas, Healing Hope International
- Investigators
- Dr. Anna Lara Kattan, MD: Regenerative Medicine, Principal investigator, Stem Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264166
- Sponsor's protocol ID
- HHI-HIE-OBS-2025-001
- Acronym
- GEN-HOPE
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be publicly shared because the registry collects information from medically fragile children with hypoxic-ischemic encephalopathy across international sites. The data contain potentially identifiable clinical and imaging information that cannot be fully anonymized without risk of re-identification. De-identified, aggregate-level results and statistical summaries will be made available through peer-reviewed publications, conference presentations, and registry updates. Access to limited, de-identified datasets for qualified researchers may be considered under controlled data-use agreements and ethics committee approval.
Publications
Lindvall O, Bjorklund A. Cell replacement therapy: helping the brain to repair itself. NeuroRx. 2004 Oct;1(4):379-81. doi: 10.1602/neurorx.1.4.379. No abstract available.
PubMed 15717041Douglas-Escobar M, Weiss MD. Hypoxic-ischemic encephalopathy: a review for the clinician. JAMA Pediatr. 2015 Apr;169(4):397-403. doi: 10.1001/jamapediatrics.2014.3269.
PubMed 25685948
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Hope International Multinational Observational Registry Evaluating Intranasal 15-Gene AAV9-PHP.eB Therapy and Functional Outcomes in Participants With Cerebral Palsy & Chronic Hypoxic-Ischemic Encephalopathy (HIE) (GEN-HOPE Study)
- ClinicalTrials.gov ID
- NCT07264166
- Acronym / sponsor ID
- GEN-HOPE / HHI-HIE-OBS-2025-001
- Conditions
- Hypoxic Brain Damage, Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischaemic Encephalopathy Due to Cardiac Arrest, Hypoxic Ischemic Encephalopathy of Newborn, Cerebral Palsy, Cerebral Palsy (CP)
- Keywords
- Hypoxic-Ischemic Encephalopathy, HIE, Cerebral Palsy, quadriplegia, hypoxic brain injury, stroke, ischemic injury, hypoxic brain damage
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Healing Hope InternationalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Jan 2032 (estimated)
- Study completion
- 15 Jun 2032 (estimated)
- First posted
- 4 Dec 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 international study, organized by Healing Hope International, is an observational registry designed to collect real-world data on participants living with chronic hypoxic ischemic encephalopathy (HIE) who receive an emerging intranasal gene therapy based on the AAV9-PHP.eB viral vector.
The investigational therapy delivers a panel of 15 restorative genes that support brain repair, reduce inflammation, promote myelination, and improve neural communication. It is administered intranasally in one or three sessions by participating international clinical teams. Because the therapy is already being offered abroad, this registry does not assign treatment but instead follows participants who have received it as part of their existing medical care.
The GEN HOPE Study aims to understand how this gene therapy affects movement, cognition, spasticity, and seizure frequency over time. Families and clinicians will share outcomes such as changes in gross motor function (GMFM-66/88), cognitive assessments (Bayley or WISC tests), and quality-of-life measures. Information on safety, laboratory results, MRI findings, and caregiver-reported experiences will also be collected.
By combining data from multiple countries, the registry seeks to evaluate whether this novel gene based approach can meaningfully improve daily function and comfort for participants with chronic HIE. Results will guide future clinical trial development and help define safe and effective standards of care for regenerative neurologic therapies.
Detailed description
The GEN HOPE Study is a multinational, real world observational registry coordinated by Healing Hope International to characterize reported safety events and functional outcomes in participants with chronic hypoxic ischemic encephalopathy (HIE), a condition commonly presenting as cerebral palsy, who have received intranasal 15-gene AAV9-PHP.eB gene therapy outside the United States.
This registry does not assign or direct any medical intervention. Instead, it prospectively collects standardized clinical and caregiver reported data from participating international sites where the therapy is already being used under local medical supervision. The aim is to document the naturalistic course of recovery following treatment and to generate evidence that may inform the design of future controlled trials.
The investigational therapy uses an AAV9-PHP.eB viral vector optimized for central nervous system delivery through the nasal mucosa. The 15 gene panel encodes factors related to neuronal plasticity, white matter repair, antiinflammatory modulation, metabolic and vascular support, and cellular longevity. Dosing schedules vary by site (single session or three session delivery), and some centers administer short-term rapamycin as an adjunctive immunomodulator.
Participants aged 2-65 years who have documented chronic HIE, stable baseline medical status, and caregiver consent to share outcome data. Key assessments include gross motor function (GMFM-66/88), cognitive and language evaluations (Bayley-III/IV or WISC-V), spasticity and seizure frequency, and quality-of-life and caregiver burden metrics. Whenever available, MRI/DTI data and laboratory monitoring are recorded. Follow-up intervals occur at approximately 3, 6, 12, 18, and 24 months post-treatment.
Data are analyzed using target-trial emulation and propensity-weighted methods to estimate treatment effects compared with matched external controls receiving standard care. The primary outcome is change in GMFM-66/88 score at 12 months. Secondary outcomes include cognitive performance, seizure burden, quality of life, and safety parameters.
All information is deidentified and stored in a secure international database compliant with data protection and ethical governance standards. Oversight is provided by an independent Data and Safety Monitoring Board (DSMB) with expertise in neurology, statistics, and gene-therapy safety.
The GEN HOPE Study seeks to accelerate understanding of gene based neurorestorative strategies and to establish a transparent evidence base supporting compassionate use access, long-term safety monitoring, and eventual clinical trial harmonization for participants affected by HIE worldwide.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intranasal 15-Gene AAV9-PHP.eB Therapy Cohort | – | –This cohort includes patients diagnosed with chronic hypoxic-ischemic encephalopathy (HIE) who receive an intranasal 15-gene AAV9-PHP.eB therapy as part of their existing medical care at participating international sites. |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of patients aged 2 to 60 years with chronic hypoxic-ischemic encephalopathy (HIE) who have undergone or are undergoing intranasal 15-gene AAV9-PHP.eB gene therapy at participating international clinical sites. Participants typically present with moderate to severe motor and cognitive impairments resulting from neonatal brain injury. Most rely on rehabilitative therapies such as occupational, physical, or speech therapy, and many have comorbid spasticity, seizure disorders, or feeding and respiratory challenges. Families voluntarily enroll to share functional, cognitive, imaging, and quality-of-life outcomes following the therapy, allowing the registry to capture real-world data from diverse treatment centers. Enrollment is open to patients meeting medical stability criteria and caregiver consent requirements, regardless of geographic origin, socioeconomic background, or previous therapy history. No healthy volunteers are included.
Key inclusion criteria (7 listed)
- Age 2 to 65 years, at the time of enrollment.
- Documented diagnosis of chronic hypoxic-ischemic encephalopathy (HIE), confirmed by medical history, MRI findings, or neonatal records.
- Stable medical condition for at least 6 months prior to enrollment (no major surgeries or hospitalizations related to HIE within that period).
- Baseline Gross Motor Function Measure (GMFM-66 or GMFM-88) score between 40% and 70%, representing moderate functional impairment.
- Completion or active receipt of intranasal 15-gene AAV9-PHP.eB therapy at a participating international clinical site under local physician supervision.
Key exclusion criteria (7 listed)
- Active systemic infection, immune deficiency, or ongoing use of immunosuppressive agents (other than short-term rapamycin used per treating physician's protocol).
- Known positive anti-AAV9 neutralizing antibody titer at baseline exceeding threshold values that may preclude effective vector transduction (if testing performed locally).
- Uncontrolled seizure activity exceeding five episodes per day at baseline despite medical therapy.
- Known or suspected malignancy, severe hepatic or renal dysfunction, or other conditions that would confound safety monitoring.
- Previous gene therapy or investigational stem cell therapy within the past 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Gross Motor Function Measure (GMFM-66/88) Score From Baseline to 12 Months
Time frame: Baseline to 12 months after treatment
Assesses change in overall motor ability using the Gross Motor Function Measure (GMFM-66/88), a validated scale for patients with cerebral palsy and/or hypoxic ischemic injury. Measures performance in lying, sitting, crawling, standing, and walking domains. Higher scores indicate greater motor function.
6 secondary outcomes
Change in Cognitive Performance (Bayley Scales) From Baseline
Time frame: Baseline to 12 months and 24 months
Change in Seizure Frequency
Time frame: Baseline to 12 months and 24 months
Change in Spasticity Using the Modified Ashworth Scale (MAS)
Time frame: Baseline to 12 months
Change in Quality of Life (PedsQL Caregiver-Reported Score)
Time frame: Baseline to 12 months and 24 months
Change in MRI/DTI Biomarkers of White-Matter Integrity
Time frame: Baseline to 12 months
Change in Cognitive Performance (WISC-V) From Baseline
Time frame: Baseline to 12 months and 24 months
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 23 Mar 2026.
- Background: PubMed 15717041Lindvall O, Bjorklund A. Cell replacement therapy: helping the brain to repair itself. NeuroRx. 2004 Oct;1(4):379-81. doi: 10.1602/neurorx.1.4.379. No abstract available.
- Background: PubMed 25685948Douglas-Escobar M, Weiss MD. Hypoxic-ischemic encephalopathy: a review for the clinician. JAMA Pediatr. 2015 Apr;169(4):397-403. doi: 10.1001/jamapediatrics.2014.3269.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be publicly shared because the registry collects information from medically fragile children with hypoxic-ischemic encephalopathy across international sites. The data contain potentially identifiable clinical and imaging information that cannot be fully anonymized without risk of re-identification. De-identified, aggregate-level results and statistical summaries will be made available through peer-reviewed publications, conference presentations, and registry updates. Access to limited, de-identified datasets for qualified researchers may be considered under controlled data-use agreements and ethics committee approval.
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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.
Dr. Anna Lara Kattan, MD: Regenerative Medicine principal investigator
Stem Solutions
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 Hypoxic Brain Damage and Hypoxic Ischaemic Encephalopathy (HIE), run by Healing Hope International at 1 site in Mexico.
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 7 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: enrolling by invitation, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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?
Change in Gross Motor Function Measure (GMFM-66/88) Score From Baseline to 12 Months (time frame: Baseline to 12 months after treatment). 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 NCT07264166, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.