Ischemic Stroke, AcutePhase 4NCT06221826

MEXIDOL® in the Rehabilitation Treatment of Patients With Acute Cerebral Failure

A Phase 4 study testing Mexidol in people with Ischemic Stroke, Acute, run by Pharmasoft at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The use of metabolic modulators creates prospects for increasing the efficiency of the rehabilitation treatment of patients with acute cerebral failure Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ischemic Stroke, Acute
What is being tested?: Mexidol
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteRussia
Study dates: 17 Apr 2023to 12 Sep 2023
Phase: Phase 4
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Acute Ischemic Stroke
Montreal Cognitive Assessment (MoCA) test >15; ≤22

Who cannot join

Under 18 years old
Epilepsy
Pregnancy
Acute failure of one or more organ systems
Purulent-inflammatory disease of any localization
Participating in any other clinical trial

Trial locations and contacts

1 site in 1 country.

Russia1 site

Brain Institute Clinic
Yekaterinburg, Sverdlovsk Oblast, 623702

Other trials in Russia

About this study

Official title: Prospective Randomized Study of the Modulating Effect of MEXIDOL® as an Adjuvant Stimulant of the Cognitive-emotional Component of the Rehabilitation Treatment in Patients With Acute Cerebral Failure

The use of metabolic modulators creates prospects for increasing the efficiency of the rehabilitation treatment of patients with acute cerebral failure

Read the detailed description

Modern neurorehabilitation is a set of basic and adjuvant treatment methods that provide a modulating effect on the neurorestoration process. The range of basic rehabilitation practices includes kinesiotherapy, occupational therapy, speech therapy, and neuropsychology. Adjuvant methods include physiotherapeutic and medicinal methods. For this study, the investigators chose MEXIDOL® as an adjuvant metabolic medicine, which has the ability to modulate receptor complexes of brain membranes, in particular benzodiazepine, GABA, acetylcholine, enhancing their ability to bind to specific ligands. This pharmacodynamic feature of the drug can have a positive effect on the psycho-emotional state of patients, which in turn will increase motivation and, consequently, the success of the rehabilitation process

Conditions: Ischemic Stroke, Acute
Being tested: Mexidol
Keywords: Ischemic Stroke, Acute Stroke, Cerebral stroke, Traumatic Brain Injury, Acute Cerebrovascular Accident, ACVA, Acute cerebral failure, Neuroprotection, Mexidol, Ethylmethylhydroxypyridine Succinate
Medical subject headings: Ischemic Stroke, Stroke, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MexidolDrug
Also called Ethylmethylhydroxypyridine Succinate
Neurocytoprotector

Study groups in NCT06221826
Study group	Role	What they receive
Main (Mexidol and standard treatment)	Experimental	Mexidol IV 500 mg for 10 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 8 weeks; and standard treatment Receives: Drug: Mexidol
Control	No intervention	Standard treatment: basic practices of kinesitherapy, occupational therapy, speech therapy, clinical psychology, supplemented by adjuvant procedures of electrotherapy and rehabilitation environment therapy. The patient's rehabilitation load was at least 3 hours a day for 12 days

What is being measured

The primary outcome is the main question the study is designed to answer.

Аssessment of Attentiveness and Performance
Schulte test [work efficiency]. Test methodology: the subject is successively shown 5 tables (5x5), in the cells of which numbers (from 1 to 25) are randomly located. It is required to show and name all the numbers in ascending order (from 1 to 25). The time spent on each table separately is recorded. Depending on the objectives, the excess of the standard (40-50 sec) time spent on each table and the dynamics of time indicators, or the average or total result of the examination for all five tables, are analyzed [test time: min value 30.0 sec, max value N/A; higher scores mean a worse outcome].
Measured: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10) and at the end of the course of therapy (Day 66).
Dynamics of Cognitive Status
The Montreal Cognitive Assessment (MoCA test) [31 point scale: min value 0, max value 30, higher scores mean a better outcome]
Measured: Assessed at screening (Day 0), at the end of the parenteral therapy phase (Day 10) and at the end of the course of therapy (Day 66); Day 66 reported
Severity of Depression
The Beck Depression Inventory (BDI scale) [64 point scale: min value 0, max value 63, higher scores mean a worse outcome]
Measured: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
Reduction in Anxiety
The Hospital Anxiety and Depression Scale (HADS) [22 point scale: min value 0, max value 21, higher scores mean a worse outcome]
Measured: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
Severity of Post Intensive Care Syndrome
The Post Intensive Care Syndrome (PICS) score [21 point scale: min value 0, max value 10 with 0,5 point scale division, higher scores mean a worse outcome]
Measured: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
Dynamics of Level of Mobility
The Rivermead index [16 point scale: min value 0, max value 15, higher scores mean a better outcome]
Measured: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
Dynamics of the Level of Life
The Rehabilitation Routing Scale (RRS) [7 point scale: min value 0, max value 6, higher scores mean a worse outcome]
Measured: Assessed at screening (Day 0), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
Severity and Dynamics of Muscle Strength
The Muscle Strength Quantitative Rating (MRC) Scale [6 point scale: min value 0, max value 5, higher scores mean a better outcome]
Measured: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
Systolic Cerebral Blood Flow Velocity (Vs) Using Transcranial Doppler (TCD) at Key Time Points
Systolic cerebral blood flow velocity (Vs) was measured in сm/sec using transcranial Doppler ultrasonography (TCD). Measurements were taken for each participant at five key time points: (1) before the first Mexidol infusion ("Before infusion"), (2) at the start of the infusion, (3) at the start of the Schulte test, (4) at the end of the Schulte test, and (5) at the end of the infusion. [Normal values: min 35 сm/sec, max 95 сm/sec]
Measured: The TCDG parameters registrated before infusion, at the start of the infusion, at the start of the Schulte test, at the end of the Schulte test, at the end of the infusion.
Overshoot Coefficient (OC) of Systolic Cerebral Blood Flow Velocity (TCD) at Key Time Points
The Overshoot Coefficient (OC) is a ratio reflecting the change in systolic cerebral blood flow velocity before and after specific stimuli. It was calculated based on transcranial Doppler measurements at five key time points: (1) before the first Mexidol infusion ("Before infusion"), (2) at the start of the infusion, (3) at the start of the Schulte test, (4) at the end of the Schulte test, and (5) at the end of the infusion. [It's calculated by the formula OC=(Vo-Vs)/Vs, the norm is not less than 1.12]
Measured: The TCDG parameters registrated before infusion, at the start of the infusion, at the start of the Schulte test, at the end of the Schulte test, at the end of the infusion.

Secondary outcomes (1)

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Registration of adverse events related to Mexidol and significant differences in vital signs between groups
Measured: Throughout the study [From Day 1 up to Day 66]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Apr 202312 Sep 2023

First posted24 Jan 2024
Study start17 Apr 2023
Primary completion12 Sep 2023
Study completion12 Sep 2023

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ischemic Stroke, AcuteStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06221826
Sponsor's protocol ID: MexidolNeuro2023
Status last verified: Apr 2025
First submitted: 15 Jan 2024
Last updated: 27 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Belkin AA, Belkin VA, Vasilchenko IE, Pinchuk EA. [Results of a cohort single-center randomized study of the modulating effect of the drug Mexidol in the rehabilitation of patients who suffered acute cerebral insufficiency]. Zh Nevrol Psikhiatr Im S S Korsakova. 2024;124(4):108-117. doi: 10.17116/jnevro2024124041108. Russian.
PubMed 38676685

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke

All Ischemic Stroke, Acute trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Study of the Modulating Effect of MEXIDOL® as an Adjuvant Stimulant of the Cognitive-emotional Component of the Rehabilitation Treatment in Patients With Acute Cerebral Failure
ClinicalTrials.gov ID: NCT06221826
Acronym / sponsor ID: MexidolNeuro2023
Conditions: Ischemic Stroke, Acute
Keywords: Ischemic Stroke, Acute Stroke, Cerebral stroke, Traumatic Brain Injury, Acute Cerebrovascular Accident, ACVA, Acute cerebral failure, Neuroprotection
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: PharmasoftIndustry (pharma, biotech, devices)
Study start: 17 Apr 2023 (actual)
Primary completion: 12 Sep 2023 (actual)
Study completion: 12 Sep 2023 (actual)
First posted: 24 Jan 2024 (actual)
Results: Posted 27 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The use of metabolic modulators creates prospects for increasing the efficiency of the rehabilitation treatment of patients with acute cerebral failure

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Main (Mexidol and standard treatment)	Experimental	Drug: MexidolMexidol IV 500 mg for 10 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 8 weeks; and standard treatment
Control	No intervention	–Standard treatment: basic practices of kinesitherapy, occupational therapy, speech therapy, clinical psychology, supplemented by adjuvant procedures of electrotherapy and rehabilitation environment therapy. The patient's rehabilitation load was at least 3 hours a day for 12 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Acute Ischemic Stroke
Montreal Cognitive Assessment (MoCA) test >15; ≤22

Key exclusion criteria (6 listed)

Under 18 years old
Epilepsy
Pregnancy
Acute failure of one or more organ systems
Purulent-inflammatory disease of any localization

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
MexidolAlso: Ethylmethylhydroxypyridine SuccinateNeurocytoprotector	Drug	Main (Mexidol and standard treatment)

Primary outcome

Аssessment of Attentiveness and Performance
Time frame: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10) and at the end of the course of therapy (Day 66).
Schulte test [work efficiency]. Test methodology: the subject is successively shown 5 tables (5x5), in the cells of which numbers (from 1 to 25) are randomly located. It is required to show and name all the numbers in ascending order (from 1 to 25). The time spent on each table separately is recorded. Depending on the objectives, the excess of the standard (40-50 sec) time spent on each table and the dynamics of time indicators, or the average or total result of the examination for all five tables, are analyzed [test time: min value 30.0 sec, max value N/A; higher scores mean a worse outcome].
Dynamics of Cognitive Status
Time frame: Assessed at screening (Day 0), at the end of the parenteral therapy phase (Day 10) and at the end of the course of therapy (Day 66); Day 66 reported
The Montreal Cognitive Assessment (MoCA test) [31 point scale: min value 0, max value 30, higher scores mean a better outcome]
Severity of Depression
Time frame: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
The Beck Depression Inventory (BDI scale) [64 point scale: min value 0, max value 63, higher scores mean a worse outcome]
Reduction in Anxiety
Time frame: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
The Hospital Anxiety and Depression Scale (HADS) [22 point scale: min value 0, max value 21, higher scores mean a worse outcome]
Severity of Post Intensive Care Syndrome
Time frame: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
The Post Intensive Care Syndrome (PICS) score [21 point scale: min value 0, max value 10 with 0,5 point scale division, higher scores mean a worse outcome]
Dynamics of Level of Mobility
Time frame: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
The Rivermead index [16 point scale: min value 0, max value 15, higher scores mean a better outcome]
Dynamics of the Level of Life
Time frame: Assessed at screening (Day 0), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
The Rehabilitation Routing Scale (RRS) [7 point scale: min value 0, max value 6, higher scores mean a worse outcome]
Severity and Dynamics of Muscle Strength
Time frame: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported
The Muscle Strength Quantitative Rating (MRC) Scale [6 point scale: min value 0, max value 5, higher scores mean a better outcome]
Systolic Cerebral Blood Flow Velocity (Vs) Using Transcranial Doppler (TCD) at Key Time Points
Time frame: The TCDG parameters registrated before infusion, at the start of the infusion, at the start of the Schulte test, at the end of the Schulte test, at the end of the infusion.
Systolic cerebral blood flow velocity (Vs) was measured in сm/sec using transcranial Doppler ultrasonography (TCD). Measurements were taken for each participant at five key time points: (1) before the first Mexidol infusion ("Before infusion"), (2) at the start of the infusion, (3) at the start of the Schulte test, (4) at the end of the Schulte test, and (5) at the end of the infusion. [Normal values: min 35 сm/sec, max 95 сm/sec]
Overshoot Coefficient (OC) of Systolic Cerebral Blood Flow Velocity (TCD) at Key Time Points
Time frame: The TCDG parameters registrated before infusion, at the start of the infusion, at the start of the Schulte test, at the end of the Schulte test, at the end of the infusion.
The Overshoot Coefficient (OC) is a ratio reflecting the change in systolic cerebral blood flow velocity before and after specific stimuli. It was calculated based on transcranial Doppler measurements at five key time points: (1) before the first Mexidol infusion ("Before infusion"), (2) at the start of the infusion, (3) at the start of the Schulte test, (4) at the end of the Schulte test, and (5) at the end of the infusion. [It's calculated by the formula OC=(Vo-Vs)/Vs, the norm is not less than 1.12]

1 secondary outcome

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Throughout the study [From Day 1 up to Day 66]

Results and safety

Results posted to the registry on 27 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Main (Mexidol and Standard Treatment)	30	30
Control	30	30

Primary outcome: Аssessment of Attentiveness and Performance

Time frame: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10) and at the end of the course of therapy (Day 66).. Median (Inter-Quartile Range). Unit: seconds

Measure	Main (Mexidol and Standard Treatment) n = 30	Control n = 30
Day 1	94.9 (69.35 to 114.95)	71.2 (65.15 to 87.9)
Day 10	75 (60.9 to 95.7)	68.15 (62.15 to 88.65)
Day 66	71.7 (56.65 to 102.3)	63 (55.73 to 82.95)

Primary outcome: Dynamics of Cognitive Status

Time frame: Assessed at screening (Day 0), at the end of the parenteral therapy phase (Day 10) and at the end of the course of therapy (Day 66); Day 66 reported. Mean (Standard Deviation). Unit: score on a scale

Measure	Main (Mexidol and Standard Treatment) n = 30	Control n = 30
Value	23.8 (2.6)	22.9 (3.0)

Primary outcome: Severity of Depression

Time frame: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10), in the middle of the oral therapy phase (Day 38) and at the end of the course of therapy (Day 66); Day 66 reported. Mean (Standard Deviation). Unit: score on a scale

Measure	Main (Mexidol and Standard Treatment) n = 30	Control n = 30
Value	7.5 (4.5)	11.4 (5.6)

Primary outcome: Reduction in Anxiety

Measure	Main (Mexidol and Standard Treatment) n = 30	Control n = 30
Value	2.6 (2.4)	4.4 (2.4)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Throughout the study [From Day 1 up to Day 66]. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Main (Mexidol and Standard Treatment)	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Control	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 38676685Belkin AA, Belkin VA, Vasilchenko IE, Pinchuk EA. [Results of a cohort single-center randomized study of the modulating effect of the drug Mexidol in the rehabilitation of patients who suffered acute cerebral insufficiency]. Zh Nevrol Psikhiatr Im S S Korsakova. 2024;124(4):108-117. doi: 10.17116/jnevro2024124041108. Russian.
Belkin AA, Belkin VA, Vasilchenko IE, Pinchuk EA. \[Results of a cohort single-center randomized study of the modulating effect of the drug Mexidol in the rehabilitation of patients who suffered acute cerebral insufficiency\]Link provided by the sponsor.

Related trials for Ischemic Stroke, Acute

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke

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 4 study testing Mexidol in people with Ischemic Stroke, Acute, run by Pharmasoft at 1 site in Russia.

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 2 inclusion and 6 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 27 Apr 2025. 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 Russia. 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?

Yes. Results are posted in the registry (first posted 27 Apr 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?

Аssessment of Attentiveness and Performance (time frame: Assessed before starting therapy (Day 1), at the end of the parenteral therapy phase (Day 10) and at the end of the course of therapy (Day 66).). The study lists 10 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 NCT06221826, 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 27 Apr 2025.