Hydrocephalus, Normal PressureNCT04599153
MRI-Volumetry in the Evaluation of Shunt Treatment for Hydrocephalus
A study testing Ventriculoperitoneal shunt opening pressure setting in people with Hydrocephalus, Normal Pressure, run by Uppsala University at 1 site in Sweden.
Trial summary
This randomized, double-blinded, cross-over study aim to evaluate the effects of shunt treatment in idiopathic normal pressure hydrocephalus (iNPH) by measuring cerebral ventricular volume and clinical symptoms at different shunt opening pressures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hydrocephalus, Normal Pressure
- What is being tested?
- Ventriculoperitoneal shunt opening pressure setting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSweden
- Study dates
- 10 Oct 2017to 28 Oct 2021
- Phase
- Interventional
- 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
- Diagnosis of idiopathic normal pressure hydrocephalus and planned treatment with shunt surgery.
Who cannot join
- Ongoing anticoagulation treatment
- Ongoing Clopidogrel treatment
- Mini mental state examination results of 15 or lower.
- Contraindications to magnetic resonance imaging.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Neurology Clinic, Östersund Hospital
Östersund, Jämtland County, 83183
About this study
Official title: MRI-Volumetry in the Evaluation of Shunt Treatment for Hydrocephalus, a Randomised, Double-blind Study.
This randomized, double-blinded, cross-over study aim to evaluate the effects of shunt treatment in idiopathic normal pressure hydrocephalus (iNPH) by measuring cerebral ventricular volume and clinical symptoms at different shunt opening pressures. Further, proteins in the cerebrospinal fluid (CSF) will be compared before and after shunt surgery.
Read the detailed description
The participants are evaluated before surgery and one month, two months, three months and three months plus one day after surgery. At each evaluation point a MRI of the brain with volumetric sequences is performed and clinical data is collected (Walking speed and steps for Time up and go, 10m walking and 3m walking backwards. Mini Mental State Examination, balance, gait, self rating of incontinence, Epworth Sleepiness Scale).
At surgery, all patients are given a ventriculoperitoneal (VP) shunt (Strata ® ) with an opening pressure setting of 1.5. After the first evaluation, one month postoperatively, participants are randomized to either a higher (2.5) or a lower (1.0) opening pressure, ratio 1:1. The opening pressure setting is blinded both for patients and the clinician during the subsequent clinical evaluations. At two months, the opening pressure is crossed over to the alternative setting (2.5 or 1.0). At three months, all participants receive the lowest shunt opening pressure (0.5) with the final evaluation the next day.
Semiautomatic measurement of the lateral as well as the third cerebral ventricles will be performed using the MRI scans and volumetric software: SyMRI (SyntheticMR AB, Linköping, Sweden)
CSF is collected at three times for each participant, from the lumbar spine pre- and 3 months postoperatively and intracranially during surgery. Further, intracranial CSF is taken through the Rickham Reservoir at the 3 months postoperative evaluation. After CSF from the participants has been collected, a single batch mass spectrometry will be performed with all the samples simultaneously.
Sample size was determined to achieve 80% power for a two tailed paired t-test for a mean change in ventricular volume of 8ml, estimated from postoperative change in ventricular volume in a previous study.
Hypotheses:
- The volume of the ventricular system in the brain decreases significantly after shunt-surgery.
- The ventricular volume is larger at high opening pressures compared to low opening pressures of the shunt.
- The decrease in ventricular volume is related to clinical outcome.
- Conditions
- Hydrocephalus, Normal Pressure
- Being tested
- Ventriculoperitoneal shunt opening pressure setting
- Keywords
- Ventriculoperitoneal Shunt, cerebral ventricular volume, cerebrospinal fluid
- Medical subject headings
- Hydrocephalus, Normal Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventriculoperitoneal shunt opening pressure settingOther
The ventriculoperitoneal shunt (Strata®) opening pressure can be changed using a magnetic tool. The possible settings are 0.5, 1.0, 1.5, 2.0, 2.5 with a higher setting number corresponding to a higher opening pressure and less drainage through the shunt. All settings are used in routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| High initial | Experimental | At the one month follow-up, the shunt is adjusted into a high opening pressure (2.5), which is crossed over to 1.0 at the two months follow-up. At the three months follow-up the opening pressure is set at 0.5 until the next day. Receives: Other: Ventriculoperitoneal shunt opening pressure setting |
| Low initial | Experimental | At the one month follow-up, the shunt is adjusted into a low opening pressure (1.0), which is crossed over to 2.5 at the two months follow-up. At the three months follow-up the opening pressure is set at 0.5 until the next day. Receives: Other: Ventriculoperitoneal shunt opening pressure setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular volume at different shunt settings (mL)
Change in ventricular volume (ml) measured by MRI
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Time of "Timed Up and Go" test at different shunt settings
Change in total walking time (sec) on "Timed Up and Go".
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Time of 10m walking test at different shunt settings
Change in total walking time (sec) on 10m walking test.
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Secondary outcomes (27)
Ventricular versus lumbar cerebrospinal fluid composition determined by mass spectrometry
Change in CSF composition from ventricular versus lumbar collection sites. Quantified with mass spectrometry and statistically compared on a protein by protein basis.
Measured: Cerebrospinal fluid is collected during diagnostic procedures before surgery, during surgery and three months and one day after surgery.
Change in CSF composition after surgery determined by mass spectrometry
Change in CSF composition before versus after surgery. Quantified with mass spectrometry and statistically compared on a protein by protein basis.
Measured: Cerebrospinal fluid is collected during diagnostic procedures before surgery, during surgery and three months and one day after surgery.
Number of steps of "Timed Up and Go" test at different shunt settings
Change in number of steps on "Timed Up and Go" test.
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Number of steps of "Timed Up and Go" test at different time points regardless of shunt setting
Change in number of steps on "Timed Up and Go" test.
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Number of steps on 10m walking test at different shunt settings
Change in number of steps on 10m walking test.
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Number of steps on 10m walking test at different time points regardless of shunt setting
Change in number of steps on 10m walking test.
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Time of 3m backwards walking test at different shunt settings
Change in total walking time (sec) on 3m backwards walking test.
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Time of 3m backwards walking test at different time points regardless of shunt setting
Change in total walking time (sec) on 3m backwards walking test.
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Number of steps on 3m backwards walking test at different shunt settings
Change in number of steps on 3m backwards walking test.
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Number of steps on 3m backwards walking test at different time points regardless of shunt setting
Change in number of steps on 3m backwards walking test.
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Mini Mental State Examination at different shunt settings
Change in Mini Mental State Examination results. (min 0, max 30, higher is better)
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Mini Mental State Examination at different time points regardless of shunt setting
Change in Mini Mental State Examination results. (min 0, max 30, higher is better)
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Epworth sleepiness scale at different time points regardless of shunt setting
Change in Epworth sleepiness scale rating. (min 0, max 24, lower is better)
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Epworth sleepiness scale at different shunt settings
Change in Epworth sleepiness scale rating. (min 0, max 24, lower is better)
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Continence scale at different time points regardless of shunt setting
Change in continence scale rating. (min 1, max 6, lower is better)
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Continence scale at different shunt settings.
Change in continence scale rating. (min 1, max 6, lower is better)
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Balance scale at different shunt settings.
Change in Balance scale rating. (min 1, max 7, lower is better)
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Balance scale at different time points regardless of shunt setting
Change in Balance scale rating. (min 1, max 7, lower is better)
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Modified rankin scale at different time points regardless of shunt setting
Change in Modified rankin scale rating. (min 0, max 6, lower is better)
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Modified rankin scale at different shunt settings.
Change in Modified rankin scale rating. (min 0, max 6, lower is better)
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Gray matter volume at different time points regardless of shunt setting
Change in whole brain grey matter volume measured by MRI (mL).
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Gray matter volume at different shunt settings.
Change in whole brain grey matter volume measured by MRI (mL).
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
White matter volume at different time points regardless of shunt setting
Change in whole brain white matter volume measured by MRI (mL).
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
White matter volume at different shunt settings.
Change in whole brain white matter volume measured by MRI (mL).
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Time of "Timed Up and Go" test at different time points regardless of shunt setting
Change in total walking time (sec) on "Timed Up and Go".
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Time of 10m walking test at different time points regardless of shunt setting
Change in total walking time (sec) on 10m walking test.
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Ventricular volume at different time points regardless of shunt setting (mL)
Change in ventricular volume (mL) measured by MRI
Measured: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start10 Oct 2017
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
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 Hydrocephalus, Normal PressureStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double blinded crossover design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarina Laurell, Uppsala University
- Investigators
- Katarina Laurell, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599153
- Sponsor's protocol ID
- Dnr 2017-254-31M
- Status last verified
- Nov 2022
- First submitted
- 19 Jul 2020
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liden S, Farahmand D, Laurell K. Volumetric effect of shunt adjustments in normal pressure hydrocephalus: a randomized, double-blind trial. J Neurosurg. 2023 Nov 17;140(5):1493-1500. doi: 10.3171/2023.9.JNS23668. Print 2024 May 1.
PubMed 37976516
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-Volumetry in the Evaluation of Shunt Treatment for Hydrocephalus, a Randomised, Double-blind Study.
- ClinicalTrials.gov ID
- NCT04599153
- Acronym / sponsor ID
- Dnr 2017-254-31M
- Conditions
- Hydrocephalus, Normal Pressure
- Keywords
- Ventriculoperitoneal Shunt, cerebral ventricular volume, cerebrospinal fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 22 Oct 2020 (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 randomized, double-blinded, cross-over study aim to evaluate the effects of shunt treatment in idiopathic normal pressure hydrocephalus (iNPH) by measuring cerebral ventricular volume and clinical symptoms at different shunt opening pressures. Further, proteins in the cerebrospinal fluid (CSF) will be compared before and after shunt surgery.
Detailed description
The participants are evaluated before surgery and one month, two months, three months and three months plus one day after surgery. At each evaluation point a MRI of the brain with volumetric sequences is performed and clinical data is collected (Walking speed and steps for Time up and go, 10m walking and 3m walking backwards. Mini Mental State Examination, balance, gait, self rating of incontinence, Epworth Sleepiness Scale).
At surgery, all patients are given a ventriculoperitoneal (VP) shunt (Strata ® ) with an opening pressure setting of 1.5. After the first evaluation, one month postoperatively, participants are randomized to either a higher (2.5) or a lower (1.0) opening pressure, ratio 1:1. The opening pressure setting is blinded both for patients and the clinician during the subsequent clinical evaluations. At two months, the opening pressure is crossed over to the alternative setting (2.5 or 1.0). At three months, all participants receive the lowest shunt opening pressure (0.5) with the final evaluation the next day.
Semiautomatic measurement of the lateral as well as the third cerebral ventricles will be performed using the MRI scans and volumetric software: SyMRI (SyntheticMR AB, Linköping, Sweden)
CSF is collected at three times for each participant, from the lumbar spine pre- and 3 months postoperatively and intracranially during surgery. Further, intracranial CSF is taken through the Rickham Reservoir at the 3 months postoperative evaluation. After CSF from the participants has been collected, a single batch mass spectrometry will be performed with all the samples simultaneously.
Sample size was determined to achieve 80% power for a two tailed paired t-test for a mean change in ventricular volume of 8ml, estimated from postoperative change in ventricular volume in a previous study.
Hypotheses:
- The volume of the ventricular system in the brain decreases significantly after shunt-surgery.
- The ventricular volume is larger at high opening pressures compared to low opening pressures of the shunt.
- The decrease in ventricular volume is related to clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blinded crossover design.
| Arm | Type | Receives |
|---|---|---|
| High initial | Experimental | Other: Ventriculoperitoneal shunt opening pressure settingAt the one month follow-up, the shunt is adjusted into a high opening pressure (2.5), which is crossed over to 1.0 at the two months follow-up. At the three months follow-up the opening pressure is set at 0.5 until the next day. |
| Low initial | Experimental | Other: Ventriculoperitoneal shunt opening pressure settingAt the one month follow-up, the shunt is adjusted into a low opening pressure (1.0), which is crossed over to 2.5 at the two months follow-up. At the three months follow-up the opening pressure is set at 0.5 until the next day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of idiopathic normal pressure hydrocephalus and planned treatment with shunt surgery.
Key exclusion criteria (4 listed)
- Ongoing anticoagulation treatment
- Ongoing Clopidogrel treatment
- Mini mental state examination results of 15 or lower.
- Contraindications to magnetic resonance imaging.
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 |
|---|---|---|
| Ventriculoperitoneal shunt opening pressure settingThe ventriculoperitoneal shunt (Strata®) opening pressure can be changed using a magnetic tool. The possible settings are 0.5, 1.0, 1.5, 2.0, 2.5 with a higher setting number corresponding to a higher opening pressure and less drainage through the shunt. All settings are used in routine clinical practice. | Other | High initial, Low initial |
Primary outcome
Ventricular volume at different shunt settings (mL)
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Change in ventricular volume (ml) measured by MRI
Time of "Timed Up and Go" test at different shunt settings
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Change in total walking time (sec) on "Timed Up and Go".
Time of 10m walking test at different shunt settings
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Change in total walking time (sec) on 10m walking test.
27 secondary outcomes
Ventricular versus lumbar cerebrospinal fluid composition determined by mass spectrometry
Time frame: Cerebrospinal fluid is collected during diagnostic procedures before surgery, during surgery and three months and one day after surgery.
Change in CSF composition after surgery determined by mass spectrometry
Time frame: Cerebrospinal fluid is collected during diagnostic procedures before surgery, during surgery and three months and one day after surgery.
Number of steps of "Timed Up and Go" test at different shunt settings
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Number of steps of "Timed Up and Go" test at different time points regardless of shunt setting
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Number of steps on 10m walking test at different shunt settings
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Number of steps on 10m walking test at different time points regardless of shunt setting
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Time of 3m backwards walking test at different shunt settings
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Time of 3m backwards walking test at different time points regardless of shunt setting
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Number of steps on 3m backwards walking test at different shunt settings
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Number of steps on 3m backwards walking test at different time points regardless of shunt setting
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Mini Mental State Examination at different shunt settings
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Mini Mental State Examination at different time points regardless of shunt setting
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Epworth sleepiness scale at different time points regardless of shunt setting
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Epworth sleepiness scale at different shunt settings
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Continence scale at different time points regardless of shunt setting
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Continence scale at different shunt settings.
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Balance scale at different shunt settings.
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Balance scale at different time points regardless of shunt setting
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Modified rankin scale at different time points regardless of shunt setting
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Modified rankin scale at different shunt settings.
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Gray matter volume at different time points regardless of shunt setting
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Gray matter volume at different shunt settings.
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
White matter volume at different time points regardless of shunt setting
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
White matter volume at different shunt settings.
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Time of "Timed Up and Go" test at different time points regardless of shunt setting
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Time of 10m walking test at different time points regardless of shunt setting
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Ventricular volume at different time points regardless of shunt setting (mL)
Time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Derived from this study: PubMed 37976516Liden S, Farahmand D, Laurell K. Volumetric effect of shunt adjustments in normal pressure hydrocephalus: a randomized, double-blind trial. J Neurosurg. 2023 Nov 17;140(5):1493-1500. doi: 10.3171/2023.9.JNS23668. Print 2024 May 1.
- 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.
Katarina Laurell, MD, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventriculoperitoneal shunt opening pressure setting in people with Hydrocephalus, Normal Pressure, run by Uppsala University at 1 site in Sweden.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 8 Nov 2022. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ventricular volume at different shunt settings (mL) (time frame: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04599153, 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 8 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.