Healthy VolunteersPhase 1NCT05753956
Safety and Pharmacokinetics of GH002 in Healthy Volunteers
A Phase 1 study testing 5 Methoxy N,N Dimethyltryptamine in people with Healthy Volunteers, run by GH Research Ireland Limited at 1 site in Netherlands.
Trial summary
The primary objectives of this study are to investigate the safety and serum pharmacokinetics of 5-MeO-DMT in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, injected doses of GH002 and in an open-label, non-randomized study design with intra-subject dose-escalation of… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- 5 Methoxy N,N Dimethyltryptamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Dec 2022to 29 Nov 2023
- Phase
- Phase 1
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at Screening.
- Is deemed in good physical health by the investigator.
- Is in good mental health in the opinion of the investigator and clinical psychologist
Who cannot join
- Has known allergies or hypersensitivity or any other contra-indication to 5-MeO-DMT.
- Has received any investigational medication, including investigational vaccines, within the 6 weeks prior to baseline
- Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the Investigator's judgement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Trial to Determine the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous GH002 in Healthy Volunteers
The primary objectives of this study are to investigate the safety and serum pharmacokinetics of 5-MeO-DMT in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, injected doses of GH002 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH002. As secondary objectives, the PK/ pharmacodynamic relationship, PD profile of GH002 as evaluated by its psychoactive effects and impact on cognitive performance, and the serum PK of the metabolite bufotenine are also assessed.
- Conditions
- Healthy Volunteers
- Being tested
- 5 Methoxy N,N Dimethyltryptamine, Placebo
- Keywords
- 5-MeO-DMT, 5-methoxy-N,N-dimethyltryptamine, Healthy Volunteers, Pharmacokinetics, Mebufotenin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 Methoxy N,N DimethyltryptamineDrug
Also called GH002, 5-MeO-DMT
GH002 administered via i.v. bolus injection(s)
PlaceboDrug
Also called GH002 placebo
GH002 placebo administered via i.v. bolus injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Dose A single dose | Experimental | A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) Receives: Drug: 5 Methoxy N,N Dimethyltryptamine; Drug: Placebo |
| Cohort B: Dose B single dose | Experimental | A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) Receives: Drug: 5 Methoxy N,N Dimethyltryptamine; Drug: Placebo |
| Cohort C: Dose C single dose | Experimental | A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) Receives: Drug: 5 Methoxy N,N Dimethyltryptamine; Drug: Placebo |
| Cohort D: Dose D single dose | Experimental | A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) Receives: Drug: 5 Methoxy N,N Dimethyltryptamine; Drug: Placebo |
| Cohort E: Dose E single dose | Experimental | A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) Receives: Drug: 5 Methoxy N,N Dimethyltryptamine; Drug: Placebo |
| Cohort F: Dose F single dose | Experimental | A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) Receives: Drug: 5 Methoxy N,N Dimethyltryptamine; Drug: Placebo |
| Cohort G: Dose G single dose | Experimental | A single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) Receives: Drug: 5 Methoxy N,N Dimethyltryptamine; Drug: Placebo |
| Cohort J: Individualized Dosing Regimen | Experimental | Administration of up to 3 doses of GH002 within a single day (doses to be confirmed following review of data from single-dose part) Receives: Drug: 5 Methoxy N,N Dimethyltryptamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: incidence of treatment emergent adverse events
Adverse events reported in the study and coded by MedDRA.
Measured: Up to 7 days
Safety and tolerability: local tolerance (injection site reactions)
Local infusion site findings will be assessed as none, mild, moderate and severe for the following signs and symptoms of the applicable site: dryness, redness, swelling, pain, tenderness, and itching and other.
Measured: Up to discharge on dosing day
Safety and tolerability: Clinically significant changes from baseline in ECG, vital signs and safety laboratory assessments
Clinically significant changes in ECG include any significant change in rate or rhythm as determined by the principal investigator
Measured: Up to 7 days
Safety and tolerability: Assessment of sedation (Modified Observer's Assessment of Alertness and Sedation [MOAA/S]) following each dose and as part of the discharge evaluation on Day 0
The Modified Observer's Assessment of Alertness and Sedation scale (MOAA/S) will be completed before and after GH002 dosing. Scored from 0 (deep sedation) to 5 (alert)
Measured: Up to discharge on dosing day
Safety and tolerability: Change from baseline in Clinician Administered Dissociative States Scale (CADSS)
The CADSS comprises 19 subjective items, ranging from 0 'not at all' to 4 'extremely. Summed together, these subscales form a total dissociative score. Combined score ranges from 0 to 76
Measured: Up to 7 days
Safety and tolerability: Assessment of subject-discharge readiness at discharge on Day 0
Assessment of Discharge Readiness on the administration day by the Principal Investigator, using the Clinical Assessment of Discharge Readiness (CADR).
Measured: Up to discharge on dosing day
Safety and tolerability: Columbia-Suicide Severity Rating Scale (C-SSRS) categorization based on the Columbia Classification Algorithm of Suicide Assessment (C-CASA).
A detailed questionnaire assessing both suicidal behaviour and suicidal ideation.
Measured: Up to 7 days
Safety and tolerability: Change from baseline in Brief Psychiatric Rating Scale (BPRS).
A scale to measure psychiatric symptoms. Each symptom is rated 1-7 and a total of 18 symptoms are scored. Combined score ranges from 18 to 126.
Measured: Up to 7 days
The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH002 to determine 5-MeO-DMT serum concentrations.
Measured: Up to 6 hours
Secondary outcomes (10)
Pharmacodynamic assessment: The dose-related psychoactive effects of GH002 as evaluated by a Visual Analogue Scale
The Peak Experience Scale (PES) is a Visual Analogue Scale scored from 0-100
Measured: Up to 1 hour after dosing
Pharmacodynamic assessment: Challenging Experiences Questionnaire (CEQ)
Completed by the subject after GH002 administration and assesses seven factors (grief, fear, death, insanity, isolation, physical distress, and paranoia) all scored from 0 to 5.
Measured: Up to 1 hour after dosing
Pharmacodynamic assessment: 30-Question Mystical Experience Questionnaire (MEQ30)
The MEQ30 is a validated procedure for assessing the extent of the psychoactive effects experienced by a subject. The validated MEQ30 uses thirty assessment questions across four areas of experience, all scored from 0 to 5.
Measured: Up to 1 hour after dosing
Pharmacodynamic assessment: Duration of the psychoactive effects (PsE)
The duration of the experience, defined as time in minutes from drug administration to time when the subject reports that any psychoactive symptoms have subsided will be recorded.
Measured: Up to 1 hour after dosing
PK/PD relationship(s) of 5-MeO-DMT
In particular the correlation between Cmax and AUC with PES score and duration of PsE as scored by the investigator will be described
Measured: Up to 1 hour after dosing
Cognitive Function: Change from baseline in Rapid visual information processing (RVP) test
A computerized test assessing the reaction time in response to a visual stimulus.
Measured: Up to 7 days
Cognitive Function: Change from baseline in Verbal recognition memory (VRM) test
The VRM test is based on successive auditory presentations of 18-word lists followed by attempted recall.
Measured: Up to 7 days
Cognitive Function: Change from baseline in Spatial Working Memory (SWM) task
The SWM test requires retention and manipulation of visuospatial information. This test has notable executive function demands, and measures strategy use as well as errors. In this task the subject has to search for tokens hidden in boxes on screen. The subject must touch a box to open the box to reveal either a yellow token or an empty box. Once the subject has found a yellow token, they must touch the outline of the right-hand side of the screen to 'store' it. The subject must then continue searching through the boxes until all of the tokens have been found. The test takes about 4 minutes to complete
Measured: Up to 7 days
Cognitive Function: Change from baseline in Digit Symbol Substitution Task (DSST)
The DSST is a global measure of cognitive ability, requiring the engagement of multiple cognitive domains in order to complete effectively. A computerized test with the task is to match digits with symbols from encoding list. The number of digits correctly encoded within 90 seconds is the performance measure.
Measured: Up to 7 days
The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of bufotenine
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH002 to determine bufotenine serum concentrations.
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start22 Dec 2022
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will include separate single and multiple-dose parts. Single-dose Part: A double-blind, placebo-controlled, randomized, dose escalation design with single doses of GH002 delivered by i.v. bolus injection in 7 consecutive cohorts with 8 subjects per cohort (randomized as 6 active and 2 placebo): Cohort A: Dose A Cohort B: Dose B Cohort C: Dose C Cohort D: Dose D Cohort E: Dose E Cohort F: Dose F Cohort G: Dose G Up to 2 additional cohorts may be added before the IDR part is initiated. These will be named cohorts H and I, if needed. Multiple-Dose Part: An open-label, non-randomized design with up to 3 doses of GH002 administered to subjects by i.v. bolus injection(s) on a single day in one cohort of 8 subjects: Cohort J: Individualized Dosing Regimen with GH002. The exact doses of study drug to be administered will be determined after an unblinded review of the safety, PK and PD data from all of the cohorts in the single dose part of the trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- GH Research Ireland Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753956
- Sponsor's protocol ID
- GH002-HV-105
- Other IDs
- 2022-002620-13
- Status last verified
- Jan 2024
- First submitted
- 23 Feb 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Determine the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous GH002 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05753956
- Acronym / sponsor ID
- GH002-HV-105
- Conditions
- Healthy Volunteers
- Keywords
- 5-MeO-DMT, 5-methoxy-N,N-dimethyltryptamine, Healthy Volunteers, Pharmacokinetics, Mebufotenin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- GH Research Ireland LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 3 Mar 2023 (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.
The primary objectives of this study are to investigate the safety and serum pharmacokinetics of 5-MeO-DMT in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, injected doses of GH002 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH002. As secondary objectives, the PK/ pharmacodynamic relationship, PD profile of GH002 as evaluated by its psychoactive effects and impact on cognitive performance, and the serum PK of the metabolite bufotenine are also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- This study will include separate single and multiple-dose parts. Single-dose Part: A double-blind, placebo-controlled, randomized, dose escalation design with single doses of GH002 delivered by i.v. bolus injection in 7 consecutive cohorts with 8 subjects per cohort (randomized as 6 active and 2 placebo): Cohort A: Dose A Cohort B: Dose B Cohort C: Dose C Cohort D: Dose D Cohort E: Dose E Cohort F: Dose F Cohort G: Dose G Up to 2 additional cohorts may be added before the IDR part is initiated. These will be named cohorts H and I, if needed. Multiple-Dose Part: An open-label, non-randomized design with up to 3 doses of GH002 administered to subjects by i.v. bolus injection(s) on a single day in one cohort of 8 subjects: Cohort J: Individualized Dosing Regimen with GH002. The exact doses of study drug to be administered will be determined after an unblinded review of the safety, PK and PD data from all of the cohorts in the single dose part of the trial
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Dose A single dose | Experimental | Drug: 5 Methoxy N,N Dimethyltryptamine, Drug: PlaceboA single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) |
| Cohort B: Dose B single dose | Experimental | Drug: 5 Methoxy N,N Dimethyltryptamine, Drug: PlaceboA single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) |
| Cohort C: Dose C single dose | Experimental | Drug: 5 Methoxy N,N Dimethyltryptamine, Drug: PlaceboA single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) |
| Cohort D: Dose D single dose | Experimental | Drug: 5 Methoxy N,N Dimethyltryptamine, Drug: PlaceboA single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) |
| Cohort E: Dose E single dose | Experimental | Drug: 5 Methoxy N,N Dimethyltryptamine, Drug: PlaceboA single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) |
| Cohort F: Dose F single dose | Experimental | Drug: 5 Methoxy N,N Dimethyltryptamine, Drug: PlaceboA single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) |
| Cohort G: Dose G single dose | Experimental | Drug: 5 Methoxy N,N Dimethyltryptamine, Drug: PlaceboA single dose of GH002 or placebo administered by i.v. bolus injection (randomized as 6 active and 2 placebo subjects) |
| Cohort J: Individualized Dosing Regimen | Experimental | Drug: 5 Methoxy N,N DimethyltryptamineAdministration of up to 3 doses of GH002 within a single day (doses to be confirmed following review of data from single-dose part) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at Screening.
- Is deemed in good physical health by the investigator.
- Is in good mental health in the opinion of the investigator and clinical psychologist
Key exclusion criteria (3 listed)
- Has known allergies or hypersensitivity or any other contra-indication to 5-MeO-DMT.
- Has received any investigational medication, including investigational vaccines, within the 6 weeks prior to baseline
- Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the Investigator's judgement.
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 |
|---|---|---|
| 5 Methoxy N,N DimethyltryptamineAlso: GH002, 5-MeO-DMTGH002 administered via i.v. bolus injection(s) | Drug | Cohort A: Dose A single dose, Cohort B: Dose B single dose, Cohort C: Dose C single dose, Cohort D: Dose D single dose, Cohort E: Dose E single dose, Cohort F: Dose F single dose, Cohort G: Dose G single dose, Cohort J: Individualized Dosing Regimen |
| PlaceboAlso: GH002 placeboGH002 placebo administered via i.v. bolus injection | Drug | Cohort A: Dose A single dose, Cohort B: Dose B single dose, Cohort C: Dose C single dose, Cohort D: Dose D single dose, Cohort E: Dose E single dose, Cohort F: Dose F single dose, Cohort G: Dose G single dose |
Primary outcome
Safety and tolerability: incidence of treatment emergent adverse events
Time frame: Up to 7 days
Adverse events reported in the study and coded by MedDRA.
Safety and tolerability: local tolerance (injection site reactions)
Time frame: Up to discharge on dosing day
Local infusion site findings will be assessed as none, mild, moderate and severe for the following signs and symptoms of the applicable site: dryness, redness, swelling, pain, tenderness, and itching and other.
Safety and tolerability: Clinically significant changes from baseline in ECG, vital signs and safety laboratory assessments
Time frame: Up to 7 days
Clinically significant changes in ECG include any significant change in rate or rhythm as determined by the principal investigator
Safety and tolerability: Assessment of sedation (Modified Observer's Assessment of Alertness and Sedation [MOAA/S]) following each dose and as part of the discharge evaluation on Day 0
Time frame: Up to discharge on dosing day
The Modified Observer's Assessment of Alertness and Sedation scale (MOAA/S) will be completed before and after GH002 dosing. Scored from 0 (deep sedation) to 5 (alert)
Safety and tolerability: Change from baseline in Clinician Administered Dissociative States Scale (CADSS)
Time frame: Up to 7 days
The CADSS comprises 19 subjective items, ranging from 0 'not at all' to 4 'extremely. Summed together, these subscales form a total dissociative score. Combined score ranges from 0 to 76
Safety and tolerability: Assessment of subject-discharge readiness at discharge on Day 0
Time frame: Up to discharge on dosing day
Assessment of Discharge Readiness on the administration day by the Principal Investigator, using the Clinical Assessment of Discharge Readiness (CADR).
Safety and tolerability: Columbia-Suicide Severity Rating Scale (C-SSRS) categorization based on the Columbia Classification Algorithm of Suicide Assessment (C-CASA).
Time frame: Up to 7 days
A detailed questionnaire assessing both suicidal behaviour and suicidal ideation.
Safety and tolerability: Change from baseline in Brief Psychiatric Rating Scale (BPRS).
Time frame: Up to 7 days
A scale to measure psychiatric symptoms. Each symptom is rated 1-7 and a total of 18 symptoms are scored. Combined score ranges from 18 to 126.
The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT
Time frame: Up to 6 hours
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH002 to determine 5-MeO-DMT serum concentrations.
10 secondary outcomes
Pharmacodynamic assessment: The dose-related psychoactive effects of GH002 as evaluated by a Visual Analogue Scale
Time frame: Up to 1 hour after dosing
Pharmacodynamic assessment: Challenging Experiences Questionnaire (CEQ)
Time frame: Up to 1 hour after dosing
Pharmacodynamic assessment: 30-Question Mystical Experience Questionnaire (MEQ30)
Time frame: Up to 1 hour after dosing
Pharmacodynamic assessment: Duration of the psychoactive effects (PsE)
Time frame: Up to 1 hour after dosing
PK/PD relationship(s) of 5-MeO-DMT
Time frame: Up to 1 hour after dosing
Cognitive Function: Change from baseline in Rapid visual information processing (RVP) test
Time frame: Up to 7 days
Cognitive Function: Change from baseline in Verbal recognition memory (VRM) test
Time frame: Up to 7 days
Cognitive Function: Change from baseline in Spatial Working Memory (SWM) task
Time frame: Up to 7 days
Cognitive Function: Change from baseline in Digit Symbol Substitution Task (DSST)
Time frame: Up to 7 days
The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of bufotenine
Time frame: Up to 6 hours
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 25 Jan 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 5 Methoxy N,N Dimethyltryptamine in people with Healthy Volunteers, run by GH Research Ireland Limited at 1 site in Netherlands.
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 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. 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 Netherlands. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety and tolerability: incidence of treatment emergent adverse events (time frame: Up to 7 days). The study lists 9 primary outcomes in all. 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 25 Jan 2024.