Brain Injuries, TraumaticPhase 4BIKeNCT05097261
Ketamine in Acute Brain Injury Patients.
A Phase 4 study testing Ketamine in people with Brain Injuries, Traumatic, run by Geert Meyfroidt, MD, PhD at 8 sites in Belgium.
Trial summary
Although, in the past years, an increasing use of ketamine in Traumatic Brain injury (TBI) has been reported as an adjunct to other sedatives, there is no evidence from randomized clinical trial to support this practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 8 sitesBelgium
- Study dates
- 6 Sep 2021to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Traumatic brain injury patients
- Age >= 18 years
- Admitted to the ICU
- Within 72 hours after admission to the initial hospital:
- ICP monitoring in place (parenchymal probe, ventricular catheter, or both)
- Requiring sedation
Who cannot join
- Known pregnancy and/or lactation
- Imminent or actual brain death upon inclusion
- Allergy or intolerance to the study medication
- Pre-existing neurocognitive disorders, pre-existing congenital or non-congenital brain dysfunction.
- Inability to obtain informed consent
- Inclusion in an interventional randomised controlled trial of which the PI indicates that co-inclusion specifically in the BIKe study is prohibited.
Show all 9Show fewer
- Therapy restriction code upon inclusion.
- Porphyria
- Glaucoma
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Belgium8 sites, 8 recruiting
- Recruiting
Imelda Bonheiden
Bonheiden
Emmanuel Van Der Hauwaert, MD
- Recruiting
AZ Sint-Jan
Bruges
Marc Bourgeois, MD
- Recruiting
Jessa Ziekenhuis
Hasselt, 3500
Jasperina Dubois, MD, jasperina.dubois@jessazh.be
- Recruiting
UZLeuven
Leuven, 3001
Liese Mebis, PhD, MSc, +3216343125, liese.mebis@uzleuven.be
Geert JP Meyfroidt, MD, PhD
- Recruiting
CHR de la Citadelle Liège
Liège
Hugues Maréchal, MD
- Recruiting
CHU de Liège
Liège
Didier Ledoux, MD
- Recruiting
AZ Delta
Roeselare
Peiter Lormans, MD
- Recruiting
AZ Turnhout
Turnhout
Eva Boonen, MD, PhD
About this study
Official title: Brain Injury and Ketamine: a Prospective, Randomized Controlled Double Blind Clinical Trial to Study the Effects of Ketamine on Sedative Sparing and Intracranial Pressure in Traumatic Brain Injury Patients.
Although, in the past years, an increasing use of ketamine in Traumatic Brain injury (TBI) has been reported as an adjunct to other sedatives, there is no evidence from randomized clinical trial to support this practice.
The BIKe (Brain Injury and Ketamine) study is a double-blind placebo controlled randomized multicenter clinical trial to examine the safety and feasibility of using ketamine as an adjunct to a standard sedative strategy in TBI patients.
Read the detailed description
In this study the effects of ketamine as an adjunct to an standard sedation regime in adult TBI patients will be investigated on the therapy intensity level and intracranial pressure. All patients will receive propofol for sedation to control ICP, to a maximum dose of 4 mg/kg/h. If the ICP is not controlled at the maximum dose of propofol, midazolam will be added, to a maximum dose of 0.3 mg/kg/h, as part of the current standard of care in the Participating Sites. All patients will receive remifentanil, fentanyl or sufentanil infusions for pain relief. The study medication (ketamine or placebo) will be started after randomization.
As part of the current standard of care in the Participating Sites, the decision for decompressive craniectomy and/or barbiturate coma will be taken after multidisciplinary consultation between the treating intensivist and neurosurgeon.
The decision to stop or reduce sedation, lies with the treating physician, based on the level of ICP control, the absence of clinical or radiological signs of deterioration of the neurologic state. In the case of barbiturate coma, the study drug will be discontinued. During and following decompressive craniectomy, the sedative regime (propofol/midazolam/study drug/ opioids) will be continued. In case of suspected or threatening Propofol-Related Infusion syndrome, propofol will be stopped and switched to midazolam. In case of hypertriglyceridemia >200 mg/dL, propofol will be reduced and if necessary, midazolam will be associated to allow control of sedation. During surgical procedures related to the traumatic brain injury or not, the study drug will not be discontinued. The use of open label administration of ketamine is not allowed during the course of the trial, i.e until hospital discharge.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Ketamine, Placebo
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
Racemic ketamine® will be administered by continuous infusion in a prefilled 50 ml syringe at a concentration of 50 mg/ml, undiluted. The ketamine dose is 1 mg/kg/h, to a maximum dose of 120 mg/hour, which corresponds to an infusion rate of 0.02 ml/kg/h to a maximum rate of 2.4 ml/h.
PlaceboDrug
Also called Saline
Placebo (NaCl 0.9%) will be provided in the same type syringes and administered at the same infusion rate as the IMP (0.02 ml/kg/h to a maximum rate of 2.4 ml/h).
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Racemic ketamine® will be administered by continuous infusion in a prefilled 50 ml syringe at a concentration of 50 mg/ml, undiluted. The ketamine dose is 1 mg/kg/h, to a maximum dose of 120 mg/hour, which corresponds to an infusion rate of 0.02 ml/kg/h to a maximum rate of 2.4 ml/h. Study patients weighing over 120 kg will not exceed the maximum dose of 120mg/kg of ketamine.
The study medication will be started within 6 hours after randomization. The IMP, ketamine, will be provided directly to each Participating Site by the official supplier of ketamine for Belgium (Pfizer). Receives: Drug: Ketamine |
| Placebo | Active comparator | The placebo (NaCl 0.9%) will be provided in the same type syringes and administered at the same infusion rate as the IMP (0.02 ml/kg/h to a maximum rate of 2.4 ml/h). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in therapeutic intensity of intracranial pressure (ICP) reducing measures, assessed by the TIL score (Therapy Intensity Level)
The primary efficacy endpoint will be the reduction in daily Therapy Intensity Level (TIL) score, based on the highest score in each item per day until study drug discontinuation (calculated every day on the available data at 7:00 AM). Scales for TIL score range from 0 (minimum) to 38 (maximum). Higher scores are related to worse outcome.
Measured: From date of randomization (and start study drug) until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.
Secondary outcomes (16)
Intracranial pressure (ICP)
The average of hourly validated intracranial pressure (mmHg) measurements per 24 hours
Measured: From date of randomization until study drug discontinuation or or date of death from any cause, whichever came first, assessed up to 6 months.
Duration of sedation
Total duration of the first period of sedative treatments (propofol, midazolam and/or dexmedetomidine)
Measured: defined as the start of the first infusion of either propofol, midazolam and/or dexmedetomidine to the cessation of the last uninterrupted infusion of either propofol, midazolam, opioids and/or dexmedetomidine, assessed up to 6 months.
Propofol
Total dose of propofol in mg per 24 hours
Measured: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed at ICU discharge, assessed up to 6 months.
Mechanical ventilation
Total duration of mechanical ventilation, defined as all types of ventilation where positive end expiratory pressure is applied, expressed in cm H2O (5 cm H2O minimum).
Measured: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.
Midazolam
Total dose of midazolam in mg per 24 hours
Measured: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.
ICU length of stay
Length of stay (number of days) in ICU
Measured: From ICU admission until ICU discharge (end of stay is defined as application for discharge in the hospital computer system, or death), assessed up to 6 months.
Hospital length of stay
Length of stay in hospital (days)
Measured: From admission to hospital until end of stay in hospital (dead or alive), assessed up to 6 months.
Richmond Agitation-Sedation scale (RASS)
Average daily RASS. Scale ranges from +4 (combative) until -5 (Unarousable).
Measured: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.
Delirium
Number of delirium-free days, assessed 3 times per day with the Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method for the ICU (CAM-ICU delirium scale).
Measured: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.
eGOS
extended Glasgow Outcome Scale (eGOS)
Measured: 6 months after the onset of TBI
ICU mortality
Mortality during ICU stay
Measured: From date of randomization until ICU discharge, assessed up to 6 months.
In-hospital mortality
Mortality during hospital stay
Measured: From date of randomization until hospital discharge, assessed up to 6 months.
Barbiturate coma incidence
The incidence of barbiturate coma
Measured: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.
Barbiturate coma duration
The duration of barbiturate coma
Measured: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.
Decompressive craniectomy
The incidence of decompressive craniectomy
Measured: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months, assessed up to 6 months.
Propofol Infusion Syndrome (PRIS)
Incidence of PRIS documented and diagnosed by the attending physician and defined as:
- Cardiac manifestations, not explained by a coronary ischemic event:
- Acute refractory bradycardia leading to asystole, or
- ECG: widening of QRS-complex, or Brugada-syndrome-like patterns (particularly Type 1: Coved-type ST-segment elevation >2mm in >1 of V1-V3 followed by a negative T-wave), or ventricular tachy-arrhythmias
- Combined with one or more of the following:
- Unexplained metabolic acidosis (base deficit > 10 mmol/L)
- Rhabdomyolysis (Creatinine kinase at least five times the upper limit of normal)
- Hyperlipidaemia (triglyceride levels > 150 mg/dl)
- Enlarged or fatty liver, apparent on CT or echography
- All occurring in patients receiving propofol for > 24h
- Diagnosed by the attending physician
Measured: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start6 Sep 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, TraumaticStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geert Meyfroidt, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liege, Centre Hospitalier Régional de la Citadelle, AZ Delta, AZ Sint-Jan AV, AZ Turnhout, Imelda Hospital, Bonheiden
- Responsible party
- Sponsor-investigator, Geert Meyfroidt, MD, PhD, KU Leuven
- Investigators
- Geert Meyfroidt, MD PhD, Principal investigator, Associate Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097261
- Sponsor's protocol ID
- S60859
- Other IDs
- 2017-004698-15, 2017
- Acronym
- BIKe
- Status last verified
- Aug 2024
- First submitted
- 8 Sep 2020
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Sloovere V, Mebis L, Wouters P, Guiza F, Boonen E, Bourgeois M, Dubois J, Ledoux D, Lormans P, Marechal H, Van der Hauwaert E, Depreitere B, Meyfroidt G. Brain Injury and Ketamine study (BIKe): a prospective, randomized controlled double blind clinical trial to study the effects of ketamine on therapy intensity level and intracranial pressure in severe traumatic brain injury patients. Trials. 2025 May 28;26(1):177. doi: 10.1186/s13063-025-08835-5.
PubMed 40437634
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Injury and Ketamine: a Prospective, Randomized Controlled Double Blind Clinical Trial to Study the Effects of Ketamine on Sedative Sparing and Intracranial Pressure in Traumatic Brain Injury Patients.
- ClinicalTrials.gov ID
- NCT05097261
- Acronym / sponsor ID
- BIKe / S60859
- Conditions
- Brain Injuries, Traumatic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Geert Meyfroidt, MD, PhDUniversity, hospital or other
- Collaborators
- University of Liege, Centre Hospitalier Régional de la Citadelle, AZ Delta, AZ Sint-Jan AV, AZ Turnhout, Imelda Hospital, Bonheiden
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although, in the past years, an increasing use of ketamine in Traumatic Brain injury (TBI) has been reported as an adjunct to other sedatives, there is no evidence from randomized clinical trial to support this practice.
The BIKe (Brain Injury and Ketamine) study is a double-blind placebo controlled randomized multicenter clinical trial to examine the safety and feasibility of using ketamine as an adjunct to a standard sedative strategy in TBI patients.
Detailed description
In this study the effects of ketamine as an adjunct to an standard sedation regime in adult TBI patients will be investigated on the therapy intensity level and intracranial pressure. All patients will receive propofol for sedation to control ICP, to a maximum dose of 4 mg/kg/h. If the ICP is not controlled at the maximum dose of propofol, midazolam will be added, to a maximum dose of 0.3 mg/kg/h, as part of the current standard of care in the Participating Sites. All patients will receive remifentanil, fentanyl or sufentanil infusions for pain relief. The study medication (ketamine or placebo) will be started after randomization.
As part of the current standard of care in the Participating Sites, the decision for decompressive craniectomy and/or barbiturate coma will be taken after multidisciplinary consultation between the treating intensivist and neurosurgeon.
The decision to stop or reduce sedation, lies with the treating physician, based on the level of ICP control, the absence of clinical or radiological signs of deterioration of the neurologic state. In the case of barbiturate coma, the study drug will be discontinued. During and following decompressive craniectomy, the sedative regime (propofol/midazolam/study drug/ opioids) will be continued. In case of suspected or threatening Propofol-Related Infusion syndrome, propofol will be stopped and switched to midazolam. In case of hypertriglyceridemia >200 mg/dL, propofol will be reduced and if necessary, midazolam will be associated to allow control of sedation. During surgical procedures related to the traumatic brain injury or not, the study drug will not be discontinued. The use of open label administration of ketamine is not allowed during the course of the trial, i.e until hospital discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetamineRacemic ketamine® will be administered by continuous infusion in a prefilled 50 ml syringe at a concentration of 50 mg/ml, undiluted. The ketamine dose is 1 mg/kg/h, to a maximum dose of 120 mg/hour, which corresponds to an infusion rate of 0.02 ml/kg/h to a maximum rate of 2.4 ml/h. Study patients weighing over 120 kg will not exceed the maximum dose of 120mg/kg of ketamine. The study medication will be started within 6 hours after randomization. The IMP, ketamine, will be provided directly to each Participating Site by the official supplier of ketamine for Belgium (Pfizer). |
| Placebo | Active comparator | Drug: PlaceboThe placebo (NaCl 0.9%) will be provided in the same type syringes and administered at the same infusion rate as the IMP (0.02 ml/kg/h to a maximum rate of 2.4 ml/h). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Traumatic brain injury patients
- Age >= 18 years
- Admitted to the ICU
- Within 72 hours after admission to the initial hospital:
Key exclusion criteria (9 listed)
- Known pregnancy and/or lactation
- Imminent or actual brain death upon inclusion
- Allergy or intolerance to the study medication
- Pre-existing neurocognitive disorders, pre-existing congenital or non-congenital brain dysfunction.
- Inability to obtain informed consent
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 |
|---|---|---|
| KetamineAlso: KetalarRacemic ketamine® will be administered by continuous infusion in a prefilled 50 ml syringe at a concentration of 50 mg/ml, undiluted. The ketamine dose is 1 mg/kg/h, to a maximum dose of 120 mg/hour, which corresponds to an infusion rate of 0.02 ml/kg/h to a maximum rate of 2.4 ml/h. | Drug | Ketamine |
| PlaceboAlso: SalinePlacebo (NaCl 0.9%) will be provided in the same type syringes and administered at the same infusion rate as the IMP (0.02 ml/kg/h to a maximum rate of 2.4 ml/h). | Drug | Placebo |
Primary outcome
Change in therapeutic intensity of intracranial pressure (ICP) reducing measures, assessed by the TIL score (Therapy Intensity Level)
Time frame: From date of randomization (and start study drug) until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.
The primary efficacy endpoint will be the reduction in daily Therapy Intensity Level (TIL) score, based on the highest score in each item per day until study drug discontinuation (calculated every day on the available data at 7:00 AM). Scales for TIL score range from 0 (minimum) to 38 (maximum). Higher scores are related to worse outcome.
16 secondary outcomes
Intracranial pressure (ICP)
Time frame: From date of randomization until study drug discontinuation or or date of death from any cause, whichever came first, assessed up to 6 months.
Duration of sedation
Time frame: defined as the start of the first infusion of either propofol, midazolam and/or dexmedetomidine to the cessation of the last uninterrupted infusion of either propofol, midazolam, opioids and/or dexmedetomidine, assessed up to 6 months.
Propofol
Time frame: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed at ICU discharge, assessed up to 6 months.
Mechanical ventilation
Time frame: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.
Midazolam
Time frame: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.
ICU length of stay
Time frame: From ICU admission until ICU discharge (end of stay is defined as application for discharge in the hospital computer system, or death), assessed up to 6 months.
Hospital length of stay
Time frame: From admission to hospital until end of stay in hospital (dead or alive), assessed up to 6 months.
Richmond Agitation-Sedation scale (RASS)
Time frame: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.
Delirium
Time frame: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.
eGOS
Time frame: 6 months after the onset of TBI
ICU mortality
Time frame: From date of randomization until ICU discharge, assessed up to 6 months.
In-hospital mortality
Time frame: From date of randomization until hospital discharge, assessed up to 6 months.
Barbiturate coma incidence
Time frame: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.
Barbiturate coma duration
Time frame: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.
Decompressive craniectomy
Time frame: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months, assessed up to 6 months.
Propofol Infusion Syndrome (PRIS)
Time frame: From date of randomization until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Derived from this study: PubMed 40437634De Sloovere V, Mebis L, Wouters P, Guiza F, Boonen E, Bourgeois M, Dubois J, Ledoux D, Lormans P, Marechal H, Van der Hauwaert E, Depreitere B, Meyfroidt G. Brain Injury and Ketamine study (BIKe): a prospective, randomized controlled double blind clinical trial to study the effects of ketamine on therapy intensity level and intracranial pressure in severe traumatic brain injury patients. Trials. 2025 May 28;26(1):177. doi: 10.1186/s13063-025-08835-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert Meyfroidt, MD PhD principal investigator
Associate Professor of Medicine
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine in people with Brain Injuries, Traumatic, run by Geert Meyfroidt, MD, PhD at 8 sites in Belgium.
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 9 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liese Mebis, PhD (003216343125, liese.mebis@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in therapeutic intensity of intracranial pressure (ICP) reducing measures, assessed by the TIL score (Therapy Intensity Level) (time frame: From date of randomization (and start study drug) until study drug discontinuation or date of death from any cause, whichever came first, assessed up to 6 months.). 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 NCT05097261, which also lists 1 linked publication.
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 22 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.