Post-Traumatic HeadachesPhase 3NCT03007420
A Prospective Controlled Treatment Trial for Post-Traumatic Headaches
A Phase 3 study testing Occipital Nerve Block (ONB) using lidocaine and dexamethosone and Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone in people with Post-Traumatic Headaches, run by Boston Children's Hospital at 2 sites in United States.
Trial summary
Post-traumatic headaches (PTH) are the most common complaint after traumatic brain injury, possibly generated by a number of stressors to the trigeminovascular and cervical plexus networks, including inflammation of the high cervical facet joints, traumatic cranial neuralgias, migraines, and myofascial injuries. Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- Post-Traumatic Headaches
- What is being tested?
- Occipital Nerve Block (ONB) using lidocaine and dexamethosone and Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jan 2018to 14 Jun 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 14 - 45 years
- History of post-traumatic headache or neck pain following a concussion or head injury within the last 12 months
- Self-reported lack of meaningful benefit with at least one previous treatment trial. Previous treatment could include a migraine prophylactic medication, a neuropathic pain medication, a physical intervention, or a cognitive-behavioral intervention.
Who cannot join
- Significant underlying psychological concerns, as determined by study psychologist up on review of standardized assessment
- Lack of parental consent and child assent (if patient age <18 years) or lack of consent (if patient age >18 years). Unable to complete the questionnaire, based on parental or patient estimation of cognitive or language limitations
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Post-traumatic headaches (PTH) are the most common complaint after traumatic brain injury, possibly generated by a number of stressors to the trigeminovascular and cervical plexus networks, including inflammation of the high cervical facet joints, traumatic cranial neuralgias, migraines, and myofascial injuries. To date, no treatment guidelines exist for PTH management except for conservative modalities, such as cognitive rest, physical therapy, and neuropathic pain medications, all of which have minimal evidence to support them.
The investigators propose a randomized, controlled, clinical trial and prospective follow-up study to evaluate the effect of invasive procedures such as occipital nerve block (ONB) and cervical medial branch block (CMBB) in the management of PTH.
Adolescents and adults (14-45 years of age) will be recruited from Boston Children's Hospital and Beth Israel Deaconess Medical Center Pain clinics, Concussion clinics and Headache clinics.
Read the detailed description
Headaches and neck pain following a concussion are potentially treatable and resolve over time. Nerve blockade may enhance the recovery of appropriate neural circuits involved in the pathophysiology of a chronic headache. Currently, no evidence-based guidelines exist for treatment of PTH. Adoption of "brain rest" for 1-2 weeks, followed by gradual return to activity and avoiding "second-impact syndrome" are current practice. The use of medications controlling neuropathic pain is of partial benefit for some. Adverse effects like sedation, mood changes, cardiac side effects of pharmacologic agents are often not compatible with the demands of athletics. For those patients where sports performance is paramount, they may therefore not be able to tolerate regular medications. The incidence of chronic post-concussive headaches (> 3 months) at one year is 8.4% - 35% and at four years is up to 25%. Therefore, patients can have a significant disability from their post-traumatic headaches for many years after their injury. Without appropriate treatment, these headaches can remain as chronic headaches. Over-the-counter and other symptomatic medication overuse can exacerbate and prolong PTH significantly, secondary to rebound headaches. Successful treatment is essential since PTH limits return to sports as well as more general activities of living, such as work and school. Most interventions currently in use partially help and take several weeks to months for a noticeable benefit. PTH interventions, including ONB and CMBB, are employed in the treatment of primary headache disorders and neck pain from cervical arthritis and may provide more improved, faster and more sustained pain relief in many patients. Also, given that most of the action of the nerve blocks is local, there are significantly fewer side effects than in more standard headache medications. Injections that use corticosteroids may be beneficial in a post-traumatic headache by reducing inflammation and therefore mechanical allodynia. Injection of corticosteroids in the cervical facet joint area has shown up to 13 months of pain relief. This prolonged effect may be secondary to central pain modulation. Ultimately, nerve blocks may be a more effective and efficient post-traumatic headache given the onset of effect and the minimal side effects.
To date, there have been no prospective studies of procedural treatments for medically refractory PTH and none in the adolescent and young adult population in whom football injuries are common. Despite the frequent clinical practice of using ONB and CMBB for occipital neuralgia, cervical arthritis, and cervicogenic headaches, there has been no adequate scientific investigation into the use of these interventions for PTH. Given that PTH is typically felt to be secondary to an inflammatory reaction to trauma, the use of injection of corticosteroids may be more effective in PTH than in common headache disorders.
The investigators propose a randomized, prospective, controlled treatment trial to evaluate the efficacy of minimally invasive nerve block interventions (ONB and CMBB) as treatments for PTH and neck pain in adolescents and adults aged 14-45 years of age with PTH.
- Conditions
- Post-Traumatic Headaches
- Being tested
- Occipital Nerve Block (ONB) using lidocaine and dexamethosone, Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occipital Nerve Block (ONB) using lidocaine and dexamethosoneDrug
Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive an ONB will receive the block with dexamethasone 2mg (steroid) each site with 3ml 1% lidocaine (local anesthetic), for a total of two sites.
Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosoneDrug
Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive CMBB will receive the block with dexamethasone 1.5mg (steroid) each site with 2 ml 1% lidocaine (local anesthetic), for a total of three sites on each side.
| Study group | Role | What they receive |
|---|---|---|
| Occipital Nerve Block | Experimental | After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a > or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months.
If patients exhibit < 50% pain reduction, the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option. Receives: Drug: Occipital Nerve Block (ONB) using lidocaine and dexamethosone |
| Cervical Medial Branch Block | Experimental | After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a > or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months.
If patients exhibit < 50% pain reduction the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option. Receives: Drug: Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Pain intensity was rated using the Numerical Rating Scale (NRS) of 0 to 10, with 0 indicating 'no pain' and 10 indicating the 'worst pain imaginable'.
Measured: One week, 1 month, 2 months, 3 months, 6months, 9 months, 12 months post-procedure
Secondary outcomes (8)
Migraine Disability Assessed Using the Migraine Disability Assessment (MIDAS)
The Migraine Disability Assessment (MIDAS) is a self-administered standardized questionnaire to quantify headache-related disability.
The MIDAS score ranges from 0 to 270. The higher the score on the MIDAS questionnaire, the greater the disability caused by headaches.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Pediatric Migraine Disability Assessment (PedMIDAS)
The Pediatric Migraine Disability Assessment (PedsMIDAS) is a self-administered standardized questionnaire to quantify headache related disability.
The PedsMIDAS score ranges from 0 to 240. The higher the score on the PedsMIDAS questionnaire, the greater the disability caused by headaches.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Headache Severity Assessed by Migraine Disability Assessment (MIDAS)
Self-administered questionnaire to quantify headache-severity using the following question:
On a scale of 0 - 10, on average how painful were these headaches? (where 0=no pain at all, and 10=pain as bad as it can be)
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Headache Severity Assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)
Self-administered questionnaire to quantify headache-related disability
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Functional Disability Inventory Scores (FDI)
The Functional Disability Inventory (FDI) was used to assess functional disability.
The FDI is scored by summing the ratings for each of its 15 items, with scores ranging from 0 to 60.
Higher scores indicate greater perceived functional disability.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Pain Disability Index (PDI)
The Pain Disability Index (PDI) was used to assess functional disability in adults.
The PDI is scored by summing the ratings of seven different life domains, each scored on a scale of 0 to 10, with higher scores indicating greater pain-related disability.
The total score can range from 0 to 70. A higher score reflects a greater impact of pain on daily activities.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
The WHOQOL-BREF produces four domain scores (Physical health, Psychological, Social Relationships, and Environment) and two overall items (overall quality of life and general health). The scores range from 4-20 with higher scores indicating a better quality of life.
Measured: Baseline, 2 months, 3 months, 6 months, 9 months, 12 months
Pediatric Quality of Life Assessment (PedsQL)
The Pediatric Quality of Life Assessment (PedsQL) is a standardized questionnaire that assesses a pediatric patient's perceptions of health-related quality of life (HRQOL) with chronic health conditions using 4 domains (Physical, Emotional, Social, School Functioning).
PedsQL scores range from 0-100 where higher scores indicate better health-related quality of life.
Measured: Baseline, 2 months, 3 months, 6 months, 9 months, 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start2 Jan 2018
- Primary completion14 Jun 2024
- Study completion14 Jun 2024
Why it stopped: Study terminated prematurely by the study Principal Investigator due to slow patient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-Traumatic HeadachesStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Harvard University
- Responsible party
- Principal investigator, Pradeep Dinakar, MD, MS, FAAP, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007420
- Sponsor's protocol ID
- IRB-P00025021
- Status last verified
- Sep 2025
- First submitted
- 22 Dec 2016
- Last updated
- 14 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share any IPD collected during the study with other researchers not included in the protocol.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Controlled Treatment Trial for Post-Traumatic Headaches
- ClinicalTrials.gov ID
- NCT03007420
- Acronym / sponsor ID
- IRB-P00025021
- Conditions
- Post-Traumatic Headaches
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated prematurely by the study Principal Investigator due to slow patient recruitment.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Harvard University
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Posted 14 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-traumatic headaches (PTH) are the most common complaint after traumatic brain injury, possibly generated by a number of stressors to the trigeminovascular and cervical plexus networks, including inflammation of the high cervical facet joints, traumatic cranial neuralgias, migraines, and myofascial injuries. To date, no treatment guidelines exist for PTH management except for conservative modalities, such as cognitive rest, physical therapy, and neuropathic pain medications, all of which have minimal evidence to support them.
The investigators propose a randomized, controlled, clinical trial and prospective follow-up study to evaluate the effect of invasive procedures such as occipital nerve block (ONB) and cervical medial branch block (CMBB) in the management of PTH.
Adolescents and adults (14-45 years of age) will be recruited from Boston Children's Hospital and Beth Israel Deaconess Medical Center Pain clinics, Concussion clinics and Headache clinics.
Detailed description
Headaches and neck pain following a concussion are potentially treatable and resolve over time. Nerve blockade may enhance the recovery of appropriate neural circuits involved in the pathophysiology of a chronic headache. Currently, no evidence-based guidelines exist for treatment of PTH. Adoption of "brain rest" for 1-2 weeks, followed by gradual return to activity and avoiding "second-impact syndrome" are current practice. The use of medications controlling neuropathic pain is of partial benefit for some. Adverse effects like sedation, mood changes, cardiac side effects of pharmacologic agents are often not compatible with the demands of athletics. For those patients where sports performance is paramount, they may therefore not be able to tolerate regular medications. The incidence of chronic post-concussive headaches (> 3 months) at one year is 8.4% - 35% and at four years is up to 25%. Therefore, patients can have a significant disability from their post-traumatic headaches for many years after their injury. Without appropriate treatment, these headaches can remain as chronic headaches. Over-the-counter and other symptomatic medication overuse can exacerbate and prolong PTH significantly, secondary to rebound headaches. Successful treatment is essential since PTH limits return to sports as well as more general activities of living, such as work and school. Most interventions currently in use partially help and take several weeks to months for a noticeable benefit. PTH interventions, including ONB and CMBB, are employed in the treatment of primary headache disorders and neck pain from cervical arthritis and may provide more improved, faster and more sustained pain relief in many patients. Also, given that most of the action of the nerve blocks is local, there are significantly fewer side effects than in more standard headache medications. Injections that use corticosteroids may be beneficial in a post-traumatic headache by reducing inflammation and therefore mechanical allodynia. Injection of corticosteroids in the cervical facet joint area has shown up to 13 months of pain relief. This prolonged effect may be secondary to central pain modulation. Ultimately, nerve blocks may be a more effective and efficient post-traumatic headache given the onset of effect and the minimal side effects.
To date, there have been no prospective studies of procedural treatments for medically refractory PTH and none in the adolescent and young adult population in whom football injuries are common. Despite the frequent clinical practice of using ONB and CMBB for occipital neuralgia, cervical arthritis, and cervicogenic headaches, there has been no adequate scientific investigation into the use of these interventions for PTH. Given that PTH is typically felt to be secondary to an inflammatory reaction to trauma, the use of injection of corticosteroids may be more effective in PTH than in common headache disorders.
The investigators propose a randomized, prospective, controlled treatment trial to evaluate the efficacy of minimally invasive nerve block interventions (ONB and CMBB) as treatments for PTH and neck pain in adolescents and adults aged 14-45 years of age with PTH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occipital Nerve Block | Experimental | Drug: Occipital Nerve Block (ONB) using lidocaine and dexamethosoneAfter enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a > or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months. If patients exhibit < 50% pain reduction, the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option. |
| Cervical Medial Branch Block | Experimental | Drug: Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosoneAfter enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a > or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months. If patients exhibit < 50% pain reduction the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 14 - 45 years
- History of post-traumatic headache or neck pain following a concussion or head injury within the last 12 months
- Self-reported lack of meaningful benefit with at least one previous treatment trial. Previous treatment could include a migraine prophylactic medication, a neuropathic pain medication, a physical intervention, or a cognitive-behavioral intervention.
Key exclusion criteria (2 listed)
- Significant underlying psychological concerns, as determined by study psychologist up on review of standardized assessment
- Lack of parental consent and child assent (if patient age <18 years) or lack of consent (if patient age >18 years). Unable to complete the questionnaire, based on parental or patient estimation of cognitive or language limitations
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 |
|---|---|---|
| Occipital Nerve Block (ONB) using lidocaine and dexamethosonePatients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive an ONB will receive the block with dexamethasone 2mg (steroid) each site with 3ml 1% lidocaine (local anesthetic), for a total of two sites. | Drug | Occipital Nerve Block |
| Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosonePatients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive CMBB will receive the block with dexamethasone 1.5mg (steroid) each site with 2 ml 1% lidocaine (local anesthetic), for a total of three sites on each side. | Drug | Cervical Medial Branch Block |
Primary outcome
Pain Score
Time frame: One week, 1 month, 2 months, 3 months, 6months, 9 months, 12 months post-procedure
Pain intensity was rated using the Numerical Rating Scale (NRS) of 0 to 10, with 0 indicating 'no pain' and 10 indicating the 'worst pain imaginable'.
8 secondary outcomes
Migraine Disability Assessed Using the Migraine Disability Assessment (MIDAS)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Pediatric Migraine Disability Assessment (PedMIDAS)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Headache Severity Assessed by Migraine Disability Assessment (MIDAS)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Headache Severity Assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Functional Disability Inventory Scores (FDI)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Pain Disability Index (PDI)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
Time frame: Baseline, 2 months, 3 months, 6 months, 9 months, 12 months
Pediatric Quality of Life Assessment (PedsQL)
Time frame: Baseline, 2 months, 3 months, 6 months, 9 months, 12 months post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The investigators do not plan to share any IPD collected during the study with other researchers not included in the protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Occipital Nerve Block (ONB) using lidocaine and dexamethosone and Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone in people with Post-Traumatic Headaches, run by Boston Children's Hospital at 2 sites in United States.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 14 Oct 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Score (time frame: One week, 1 month, 2 months, 3 months, 6months, 9 months, 12 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.