Transcranial Direct Current StimulationNCT05492032
Cumulative and Booster Effects of Multisession Prefrontal Transcranial Direct Current Stimulation in Adolescents With ASD
A study testing Active-tDCS and Cognitive training in people with Transcranial Direct Current Stimulation and Autistic Spectrum Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Autism spectrum disorder (ASD) is a pervasive and lifelong developmental disorder that currently affects 1 in 54 children. Individuals with autism are often severely impaired in communication, social skills, and cognitive functions. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Transcranial Direct Current Stimulation, Autistic Spectrum Disorder, Electroencephalography
- What is being tested?
- Active-tDCS and Cognitive training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Jun 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Individuals who are confirmed by a clinical psychologist based on the Diagnostic and Statistical Manual of Mental Disorders-5th Ed (DSM-V) criteria of Autism spectrum disorder and structured interview with their parents or primary caregivers on their developmental history using the Autism Diagnostic Interview-Revised (ADI-R).
- Individuals with ASD who are comorbid with ADHD symptoms will be included if they were willing to abstain from the use of these medications at least 96 hours before the commencement, until the completion, of the treatment.
- In view of the fact that neuroadaptation to antipsychotics typically occurs within six months, potential participants who are prescribed antipsychotic medications will only be included if the dosage of the medication remained unchanged for six months or more before the experimental period.
Who cannot join
- Individuals without a confirmed diagnosis from the clinical psychologist, with a history of other neurological and psychiatric disorders and head trauma, or on psychiatric medication will be excluded from the study.
- In view of the possibility of seizure induction by tDCS, potential ASD participants comorbid with epilepsy will be excluded.
- Potential participants comorbid with mood or anxiety disorders will also be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Melody Chan, PhD contact
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hung Hom, Kowloon
Yvonne Han, PhD, 27667578, yvonne.han@polyu.edu.hk
Melody Chan, PhD, mei-yan-melody.chan@connect.polyu.hk
About this study
Official title: Cumulative and Booster Effects of Multisession Prefrontal Transcranial Direct-Current Stimulation (tDCS) on Cognitive and Social Impairments in Adolescents With Autism Spectrum Disorder
Autism spectrum disorder (ASD) is a pervasive and lifelong developmental disorder that currently affects 1 in 54 children. Individuals with autism are often severely impaired in communication, social skills, and cognitive functions. Particularly detrimental characteristics typical of ASD include the inability to relate to people and the display of repetitive stereotyped behaviors and uncontrollable temper outbursts over trivial changes in the environment, which often cause emotional stress for the children, their families, schools and neighborhood communities. To date, there is no cure for ASD, and the disorder remains a highly disabling condition. Recently, transcranial direct current stimulation (tDCS), a noninvasive neuromodulation technique, has shown great promise as an effective and cost-effective tool for reducing core symptoms, such as anxiety, aggression, impulsivity, and poor social communication, in patients with autism. Although the empirical findings in patients with ASD are encouraging, it remains to be determined whether these experimental data can be translated into real-world benefits. An important next step is to better understand the factors affecting the long-term efficacy of tDCS treatment - in particular, the possible risk factors associated with relapse in patients with ASD and the role of booster session tDCS as an add-on treatment to induce long-lasting neuroplastic effects in ASD.
- Conditions
- Transcranial Direct Current Stimulation, Autistic Spectrum Disorder, Electroencephalography, Booster Effects
- Being tested
- Active-tDCS, Sham-tDCS, Cognitive training
- Keywords
- Autism, ASD, tDCS, Treatment outcome, EEG, E/I ratio, Booster effects, Cognitive function
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active-tDCSDevice
For active-tDCS condition, participants will receive stimulation on the dorsolateral prefrontal cortex with ramp up and ramp down mode for 10 seconds, eliciting a tingling sensation on the scalp that fades over seconds. Following that, a twenty-minute executive functional training task will be initiated five minutes subsequent to the stimulation mode, and the stimulation will be terminated when the training task ends.
Sham-tDCSDevice
For sham-tDCS condition, participants will receive initial stimulation with ramp up and ramp down mode for 30 seconds, eliciting a tingling sensation on the scalp then it will be discontinued. Participants will also receive the twenty-minute executive functional training task five minutes subsequent to the stimulation mode.
Cognitive trainingBehavioural
Participants will complete an online cognitive training program consisting of 10 consecutive daily weekday training sessions while they receive either the active or sham tDCS stimulation. Each training session will last for 20 minutes. The online cognitive training program will comprise five exercises assessing information processing speed and executive function capacities. Each exercise will take approximately 4 minutes to complete. Given many studies, across different neurological/neuropsychiatric diagnoses, especially for people with autism, it has long been established that social skills and functioning are closely related, and multiple studies have shown that executive function training can improve social functioning in autism or vice versa (i.e. social skills training improves executive functioning in autism), it is reasonable to include cognitive training in this tDCS protocol.
| Study group | Role | What they receive |
|---|---|---|
| Active cathodal (inhibitory) tDCS vs. Sham-tDCS condition | Experimental | Experimental group: active multisession tDCS + active booster tDCS vs Active control group: sham multisession tDCS + sham booster tDCS
To test whether active cathodal [inhibitory] tDCS over the left dlPRC will facilitate learning through stimulation and thus improve cognitive function in patients with ASD, the primary outcomes (SRS-2 scores) of the two groups at the start (T0), 1-month (T1), 3-month (T2), 6-month (T3), and at the end of study i.e. 12-months (T4) will be compared. Receives: Device: Active-tDCS; Device: Sham-tDCS; Behavioral: Cognitive training |
| Active booster tDCS treatment vs. Sham booster tDCS treatment | Experimental | Experimental group: active multisession tDCS + active booster tDCS vs Active control group: active multisession tDCS + sham booster tDCS
To test whether booster treatment cycles of tDCS will prolong the cognitive benefits in individuals with ASD), the primary outcome, the total SRS-2 score, and the secondary outcomes, the E/I ratio and the cognitive composite score at the start (T0), 1-month (T1), 3-month (T2), 6-month (T3), and at the end of study i.e. 12-months (T4), will be compared. Receives: Device: Active-tDCS; Device: Sham-tDCS; Behavioral: Cognitive training |
| Change in EEG E/I ratios in the active tDCS vs. sham tDCS groups | Experimental | Experimental group: active multisession tDCS + active booster tDCS vs Active control group: sham multisession tDCS + sham booster tDCS
To test whether enhanced neuronal network organization, as indicated by EEG E/I ratios, in patients with ASD will mediate the beneficial effects of tDCS in terms of improvements in cognitive function, measurements taken at baseline, 1-day and 1-month after tDCS treatment will be compared. The change in EEG E/I ratios in patients in the active tDCS and sham tDCS groups will be compared using E/I ratios averaged from channels Fp1, F3, and F7 to increase the signal-to-noise ratio of the EEG data and to represent the left frontal E/I ratio. Receives: Device: Active-tDCS; Device: Sham-tDCS; Behavioral: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in social responsiveness - Social Responsiveness Scale-2nd edition (SRS-2)
SRS-2 is a sensitive measure of social functioning in children that detects even subtle symptoms that are highly related to ASD. It uses a four-point scale and focuses on different aspects of socialization. The total score reflects the clinical effectiveness of tDCS, and higher scores indicate greater symptom severity. It has been shown that SRS-2 is sensitive to detect changes in social communication improvement related to improved cognitive functioning after treatment. SRS-2 assessments will be conducted before and immediately after tDCS treatment.
Measured: First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points)
Secondary outcomes (3)
tDCS safety and clinical response in tDCS outcome
To assess tDCS safety, participants will be asked to complete an adverse effects questionnaire (AEQ) which charts the presence of uncomfortable sensations and changes emotions, cognition and perceptions.
Based on the tDCS outcome recorded immediately after tDCS treatment, participants will be categorized into responders and non-responders based on the percentage of change in the total SRS score. Participants who show reductions of at least 10% in total SRS scores as compared to baseline scores will be considered responders. This percentage reduction benchmark was set with reference to the minimal clinically important difference (MCID) and calculated using the standard error measurement method from an ASD sample in a previous randomized controlled trial.
Measured: First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points)
Change in neuropsychological measures - CANTAB® cognitive tests
Cambridge Neuropsychological Test Automated Battery (CANTAB®) includes computerized tests that are correlated to neural networks and have demonstrated high sensitivity in detecting changes in neuropsychological performance. The tests in this battery-the Reaction Time (RTI), Spatial Working Memory (SWM), and Multitasking Tests (MTT)-are well validated and are highly sensitive to the core domains impaired in patients with ASD, including to response/reaction time, working memory, attention, inhibition, and cognitive flexibility.
Measured: First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points)
Change in EEG E/I ratio measurement
Each participant will be tested individually using the Starstim 32 hybrid EEG/tCS device (Neuroelectrics®) to collect EEG data. EEG measurements will be taken in the resting state before and immediately after the 10-session intervention program. Participants will be instructed to sit still and focus their attention on a "+" displayed on a computer monitor during eyes-open resting conditions for 5 minutes. Raw data will be processed with the EEGLAB Toolbox using MATLAB® R2019a (The MathWorks Inc., Natick, Massachusetts, USA). Data from 19 electrode positions (Fp1, Fp2, F3, F4, F7, F8, Fz, T3, T4, T5, T6, C3, C4, Cz, P3, P4, Pz, O1, and O2) will be used for analysis.
Measured: First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start2 Jun 2022
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic 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
- Parallel groups
- Model description
- This is a one-year parallel design (triple-arm), double-blind RCT. Participants will be randomly assigned to receive either (1) active daily tDCS with computerized executive function training in weeks 0-2, followed by active bimonthly booster tDCS sessions in weeks 3-14, and active monthly booster tDCS sessions in weeks 15-52; (2) active daily tDCS with computerized executive function training in weeks 0-2, followed by sham bimonthly booster tDCS sessions in weeks 3-14, and sham monthly booster tDCS sessions in weeks 15-52, or sham daily tDCS with computerized executive function training in weeks 0-2, followed by sham bimonthly booster tDCS sessions in weeks 3-14, and sham monthly booster tDCS sessions in weeks 15-52.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Yvonne Han, The Hong Kong Polytechnic University
- Investigators
- Yvonne Han, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492032
- Sponsor's protocol ID
- HSEARS20220216004-01
- Status last verified
- Oct 2025
- First submitted
- 5 Aug 2022
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cumulative and Booster Effects of Multisession Prefrontal Transcranial Direct-Current Stimulation (tDCS) on Cognitive and Social Impairments in Adolescents With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05492032
- Acronym / sponsor ID
- HSEARS20220216004-01
- Conditions
- Transcranial Direct Current Stimulation, Autistic Spectrum Disorder, Electroencephalography, Booster Effects
- Keywords
- Autism, ASD, tDCS, Treatment outcome, EEG, E/I ratio, Booster effects, Cognitive function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Aug 2022 (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.
Autism spectrum disorder (ASD) is a pervasive and lifelong developmental disorder that currently affects 1 in 54 children. Individuals with autism are often severely impaired in communication, social skills, and cognitive functions. Particularly detrimental characteristics typical of ASD include the inability to relate to people and the display of repetitive stereotyped behaviors and uncontrollable temper outbursts over trivial changes in the environment, which often cause emotional stress for the children, their families, schools and neighborhood communities. To date, there is no cure for ASD, and the disorder remains a highly disabling condition. Recently, transcranial direct current stimulation (tDCS), a noninvasive neuromodulation technique, has shown great promise as an effective and cost-effective tool for reducing core symptoms, such as anxiety, aggression, impulsivity, and poor social communication, in patients with autism. Although the empirical findings in patients with ASD are encouraging, it remains to be determined whether these experimental data can be translated into real-world benefits. An important next step is to better understand the factors affecting the long-term efficacy of tDCS treatment - in particular, the possible risk factors associated with relapse in patients with ASD and the role of booster session tDCS as an add-on treatment to induce long-lasting neuroplastic effects in ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a one-year parallel design (triple-arm), double-blind RCT. Participants will be randomly assigned to receive either (1) active daily tDCS with computerized executive function training in weeks 0-2, followed by active bimonthly booster tDCS sessions in weeks 3-14, and active monthly booster tDCS sessions in weeks 15-52; (2) active daily tDCS with computerized executive function training in weeks 0-2, followed by sham bimonthly booster tDCS sessions in weeks 3-14, and sham monthly booster tDCS sessions in weeks 15-52, or sham daily tDCS with computerized executive function training in weeks 0-2, followed by sham bimonthly booster tDCS sessions in weeks 3-14, and sham monthly booster tDCS sessions in weeks 15-52.
| Arm | Type | Receives |
|---|---|---|
| Active cathodal (inhibitory) tDCS vs. Sham-tDCS condition | Experimental | Device: Active-tDCS, Device: Sham-tDCS, Behavioral: Cognitive trainingExperimental group: active multisession tDCS + active booster tDCS vs Active control group: sham multisession tDCS + sham booster tDCS To test whether active cathodal [inhibitory] tDCS over the left dlPRC will facilitate learning through stimulation and thus improve cognitive function in patients with ASD, the primary outcomes (SRS-2 scores) of the two groups at the start (T0), 1-month (T1), 3-month (T2), 6-month (T3), and at the end of study i.e. 12-months (T4) will be compared. |
| Active booster tDCS treatment vs. Sham booster tDCS treatment | Experimental | Device: Active-tDCS, Device: Sham-tDCS, Behavioral: Cognitive trainingExperimental group: active multisession tDCS + active booster tDCS vs Active control group: active multisession tDCS + sham booster tDCS To test whether booster treatment cycles of tDCS will prolong the cognitive benefits in individuals with ASD), the primary outcome, the total SRS-2 score, and the secondary outcomes, the E/I ratio and the cognitive composite score at the start (T0), 1-month (T1), 3-month (T2), 6-month (T3), and at the end of study i.e. 12-months (T4), will be compared. |
| Change in EEG E/I ratios in the active tDCS vs. sham tDCS groups | Experimental | Device: Active-tDCS, Device: Sham-tDCS, Behavioral: Cognitive trainingExperimental group: active multisession tDCS + active booster tDCS vs Active control group: sham multisession tDCS + sham booster tDCS To test whether enhanced neuronal network organization, as indicated by EEG E/I ratios, in patients with ASD will mediate the beneficial effects of tDCS in terms of improvements in cognitive function, measurements taken at baseline, 1-day and 1-month after tDCS treatment will be compared. The change in EEG E/I ratios in patients in the active tDCS and sham tDCS groups will be compared using E/I ratios averaged from channels Fp1, F3, and F7 to increase the signal-to-noise ratio of the EEG data and to represent the left frontal E/I ratio. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Individuals who are confirmed by a clinical psychologist based on the Diagnostic and Statistical Manual of Mental Disorders-5th Ed (DSM-V) criteria of Autism spectrum disorder and structured interview with their parents or primary caregivers on their developmental history using the Autism Diagnostic Interview-Revised (ADI-R).
- Individuals with ASD who are comorbid with ADHD symptoms will be included if they were willing to abstain from the use of these medications at least 96 hours before the commencement, until the completion, of the treatment.
- In view of the fact that neuroadaptation to antipsychotics typically occurs within six months, potential participants who are prescribed antipsychotic medications will only be included if the dosage of the medication remained unchanged for six months or more before the experimental period.
Key exclusion criteria (3 listed)
- Individuals without a confirmed diagnosis from the clinical psychologist, with a history of other neurological and psychiatric disorders and head trauma, or on psychiatric medication will be excluded from the study.
- In view of the possibility of seizure induction by tDCS, potential ASD participants comorbid with epilepsy will be excluded.
- Potential participants comorbid with mood or anxiety disorders will also be excluded.
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 |
|---|---|---|
| Active-tDCSFor active-tDCS condition, participants will receive stimulation on the dorsolateral prefrontal cortex with ramp up and ramp down mode for 10 seconds, eliciting a tingling sensation on the scalp that fades over seconds. Following that, a twenty-minute executive functional training task will be initiated five minutes subsequent to the stimulation mode, and the stimulation will be terminated when the training task ends. | Device | Active booster tDCS treatment vs. Sham booster tDCS treatment, Active cathodal (inhibitory) tDCS vs. Sham-tDCS condition, Change in EEG E/I ratios in the active tDCS vs. sham tDCS groups |
| Sham-tDCSFor sham-tDCS condition, participants will receive initial stimulation with ramp up and ramp down mode for 30 seconds, eliciting a tingling sensation on the scalp then it will be discontinued. Participants will also receive the twenty-minute executive functional training task five minutes subsequent to the stimulation mode. | Device | Active booster tDCS treatment vs. Sham booster tDCS treatment, Active cathodal (inhibitory) tDCS vs. Sham-tDCS condition, Change in EEG E/I ratios in the active tDCS vs. sham tDCS groups |
| Cognitive trainingParticipants will complete an online cognitive training program consisting of 10 consecutive daily weekday training sessions while they receive either the active or sham tDCS stimulation. Each training session will last for 20 minutes. The online cognitive training program will comprise five exercises assessing information processing speed and executive function capacities. Each exercise will take approximately 4 minutes to complete. Given many studies, across different neurological/neuropsychiatric diagnoses, especially for people with autism, it has long been established that social skills and functioning are closely related, and multiple studies have shown that executive function training can improve social functioning in autism or vice versa (i.e. social skills training improves executive functioning in autism), it is reasonable to include cognitive training in this tDCS protocol. | Behavioural | Active booster tDCS treatment vs. Sham booster tDCS treatment, Active cathodal (inhibitory) tDCS vs. Sham-tDCS condition, Change in EEG E/I ratios in the active tDCS vs. sham tDCS groups |
Primary outcome
Change in social responsiveness - Social Responsiveness Scale-2nd edition (SRS-2)
Time frame: First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points)
SRS-2 is a sensitive measure of social functioning in children that detects even subtle symptoms that are highly related to ASD. It uses a four-point scale and focuses on different aspects of socialization. The total score reflects the clinical effectiveness of tDCS, and higher scores indicate greater symptom severity. It has been shown that SRS-2 is sensitive to detect changes in social communication improvement related to improved cognitive functioning after treatment. SRS-2 assessments will be conducted before and immediately after tDCS treatment.
3 secondary outcomes
tDCS safety and clinical response in tDCS outcome
Time frame: First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points)
Change in neuropsychological measures - CANTAB® cognitive tests
Time frame: First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points)
Change in EEG E/I ratio measurement
Time frame: First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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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.
Melody Chan, PhD contact
Yvonne Han, PhD principal investigator
The Hong Kong Polytechnic 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 Active-tDCS and Cognitive training in people with Transcranial Direct Current Stimulation and Autistic Spectrum Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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: looking for participants now, as of the sponsor's last update on 26 Nov 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yvonne Han, PhD (+852 2766 7578, yvonne.han@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in social responsiveness - Social Responsiveness Scale-2nd edition (SRS-2) (time frame: First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points)). 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 26 Nov 2025.