Attention Deficit Hyperactivity DisorderEarly Phase 1MBAT-CNCT04737512
Mindfulness-Based ADHD Treatment for Children: a Feasibility Study
A Early Phase 1 study testing Mindfulness-Based ADHD Treatment for Children and Goal-Standard Medication (Treatment as Usual) in people with Attention Deficit Hyperactivity Disorder, run by Yale University at 1 site in United States.
Trial summary
Attention-Deficit/Hyperactivity Disorder (ADHD) affects 11% of children and leads to adverse outcomes. Medications, while often effective in reducing certain ADHD symptoms, have many disadvantages, including misuse and side effects. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Mindfulness-Based ADHD Treatment for Children and Goal-Standard Medication (Treatment as Usual)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 29 Oct 2024
- Phase
- Early 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 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child of any sex/gender ages 7-13;
- fulfills the Diagnostic Statistical Manual -5 criteria for ADHD (inattentive, hyperactive, or combined);
- speaks English;
- understands the assent form and provides informed assent;
- has parents who understand the consent form and provide informed consent;
- can commit to the full length of the protocol;
- is willing to undergo a wash-out period if already on ADHD medications;
- is willing to be randomized to treatment condition.
Who cannot join
- physical conditions that may preclude participation;
- any conditions contraindicated for ADHD medications, or potential participants taking monoamine-oxidase inhibitors;
- pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical & Affective Neuroscience Lab
New Haven, Connecticut, 06510
About this study
Attention-Deficit/Hyperactivity Disorder (ADHD) affects 11% of children and leads to adverse outcomes. Medications, while often effective in reducing certain ADHD symptoms, have many disadvantages, including misuse and side effects. Behavioral interventions do not have these adverse effects, but they are not as effective. Mindfulness is a candidate intervention for ADHD in elementary school children, but has not been systematically and rigorously studied.
This study will evaluate the feasibility and acceptability of Mindfulness-Based ADHD Treatment for Children (MBAT-C). MBAT-C is designed for children at precisely the age when ADHD-relevant neurocognitive systems are developing and clinical symptoms begin to appear. Forty-five children from the New Haven, CT area, ages 7-13, will be recruited to participate in this randomized-controlled feasibility trial that will compare MBAT-C, medication, and a combined intervention.
Read the detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) affects 11% of American children. ADHD is a source of considerable psychosocial, educational, and neurocognitive impairment. It is co-morbid with multiple psychiatric disorders and poses an economic burden. Pharmacotherapy is often the first-line treatment for children with ADHD, but such medications are associated with adverse effects, including insomnia, loss of appetite, headaches, stomachaches, tics, moodiness, and irritability. Further, concerns about substance misuse and diversion, as well as parental preference, can limit the use and utility of medications. These limitations underscore the urgency of developing behavioral interventions that do not pose such concerns. At this time, however, behavioral treatments for ADHD are generally less effective than pharmacotherapy, emphasizing the need for better non-pharmacologic interventions.
Mindfulness-defined here as nonjudgmentally paying attention to the present moment-is a promising behavioral approach to ADHD treatment, as evidence suggests that mindfulness improves attention in both healthy adults, and those with ADHD. Mindfulness also improves neurocognitive outcomes in children and adolescents, including executive function and attention, suggesting that mindfulness may be an effective treatment for ADHD in young persons.
This is a feasibility study of a novel intervention: Mindfulness-Based ADHD Treatment for Children (MBAT-C). MBAT-C is derived from Mindfulness-Based Stress Reduction (MBSR), a well-known and extensively-studied mindfulness intervention. Unlike all other mindfulness-based interventions, however, MBAT-C is tailored to the needs, abilities, and vulnerabilities of children with ADHD through the use of age-appropriate class length, homework assignments, contemplative practices, and discussion topics. Specifically, MBAT-C includes 16 twice-weekly 30-minute sessions over 8 weeks. Each session includes two brief meditations, discussion, an exercise, and homework.
In this study, 45 children ages 7-13 with ADHD will be randomized into one of three treatment groups: MBAT-C, medication (MED), or a combined intervention (COM).
The aims of the study are as follows:
Aim 1: Evaluate feasibility of MBAT-C
Aim 2. Measure within-group change from pre- to post-treatment on ADHD-relevant outcomes.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Mindfulness-Based ADHD Treatment for Children, Goal-Standard Medication (Treatment as Usual)
- Keywords
- ADHD, mindfulness, meditation, children, feasibility, acceptability
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based ADHD Treatment for ChildrenBehavioural
MBAT-C is derived from Mindfulness-Based Stress Reduction (MBSR), a well-known and extensively-studied mindfulness intervention. Unlike all other mindfulness-based interventions, however, MBAT-C is tailored to the needs, abilities, and vulnerabilities of children with ADHD through the use of age-appropriate class length, homework assignments, contemplative practices, and discussion topics.
Goal-Standard Medication (Treatment as Usual)Biological
Participants will receive gold-standard, non-experimental medication. This treatment arm relies on a step-by-step approach that is designed to mimic pharmacologic treatment-as-usual in the community. The treatment algorithm is as follows:
- All participants will start with Concerta; Ritalin may be started if the effect of Concerta wears off mid-day;
- If Concerta +/- Ritalin is ineffective or not tolerated, participants will progress to Vyvanse; Adderall may be started if the effect of Vyvanse wears off mid-day;
- If Vyvanse +/- Adderall is also ineffective or not tolerated, participants will progress to Kapvay;
- If Kapvay is ineffective or not tolerated, participants will progress to Intuniv.
- Alternative combinations of the above medications will be considered if the above combinations are ineffective or otherwise not tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based ADHD Treatment for Children | Experimental | Not described Receives: Behavioral: Mindfulness-Based ADHD Treatment for Children |
| Medication | Active comparator | Not described Receives: Biological: Goal-Standard Medication (Treatment as Usual) |
| Combined (MBAT-C + medication) | Active comparator | Not described Receives: Behavioral: Mindfulness-Based ADHD Treatment for Children; Biological: Goal-Standard Medication (Treatment as Usual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Total number of participants enrolled
Measured: Completion of study (up to 30 months)
Recruitment
Average time from screening to enrollment
Measured: Completion of study (up to 30 months)
Randomization
Percent of eligible screened participants who enroll and are randomized
Measured: Completion of study (up to 30 months)
Randomization
Percent of enrolled who attend at least one session
Measured: Completion of study (up to 30 months)
Attendance (MBAT-C Condition)
Average number of minutes attended
Measured: Post-Assessment (8-10 weeks)
Attendance (Medication Condition)
Average percent of scheduled medication visits attended
Measured: Post-Assessment (8-10 weeks)
Attendance (Combined Condition)
Average percent of MBAT-C and medication visits attended
Measured: Post-Assessment (8-10 weeks)
Attendance (Combined Condition)
Average number of minutes of MBAT-C attended
Measured: Post-Assessment (8-10 weeks)
Medication Adherence (for medication and combined conditions only)
Average percent of prescribed doses taken
Measured: Post-Assessment (8-10 weeks)
Retention
Percent of enrolled who attend >60% of study sessions
Measured: Post-Assessment (8-10 weeks)
Participation - Student Rated (for MBAT-C and combined conditions only)
Average student ratings of participation of each MBAT-C session, as measured by the Research Assessment Package for Schools - Student (RAPS-SE); RAPS-SE is a 6 item measure with individual item scores ranging from 1 to 4; overall score is average of 3 individual items; higher scores indicate higher participation
Measured: Post-Assessment (8-10 weeks)
Participation - Teacher Rated (for MBAT-C and combined conditions only)
Average teacher ratings of participation of each MBAT-C session, as measured by the Research Assessment Package for Schools - Teacher Engagement (RAPS-TE); RAPS-TE is a 3 item measure of participation with individual item scores ranging from 1 to 4; overall score is average of 3 individual items; higher scores indicate greater participation
Measured: Post-Assessment (8-10 weeks)
Homework Completion (for MBAT-C and combined conditions only)
Average number of days per week practicing
Measured: Post-Assessment (8-10 weeks)
Homework Completion (for MBAT-C and combined conditions only)
Average number of total minutes practiced
Measured: Post-Assessment (8-10 weeks)
Acceptability
Average score on Acceptability of Intervention Measure (AIM); AIM is a 4 item measure of acceptability with individual item scores ranging from 1-4; overall score is sum of individual items; higher scores indicate higher acceptability
Measured: Post-Assessment (8-10 weeks)
Secondary outcomes (8)
ADHD Symptoms
Pre-assessment to post-assessment difference on ADHD Rating Scale (ADHD-RS); the ADHD-RS is an 18-item scale that assess core ADHD symptoms as reported by parents, with scores ranging from 0 to 54; higher scores indicate greater ADHD symptoms
Measured: Post-Assessment (8-10 weeks)
Total Problems
Pre-assessment to post-assessment difference in the total score on the total problems subscale on the Child Behavior Checklist (CBCL), which is comprised of 98 questions; individual item scores range from 0 to 2; higher scores indicate higher amount of behavioral problems
Measured: Post-Assessment (8-10 weeks)
Externalizing Problems
Pre-assessment to post-assessment difference in score on the externalizing problems subscale on the Child Behavior Checklist (CBCL), which is comprised of 33 questions; individual item scores range from 0 to 2; higher scores indicate higher amount of externalizing problems
Measured: Post-Assessment (8-10 weeks)
Attention
Pre-assessment to post-assessment difference on Flanker Task performance, as assessed by accuracy
Measured: Post-Assessment (8-10 weeks)
Executive Function
Pre-assessment to post-assessment difference on Hearts and Flowers Task, as assessed by accuracy
Measured: Post-Assessment (8-10 weeks)
Working Memory
Pre-assessment to post-assessment difference in performance on the List Sorting Working Memory Task, as assessed by accuracy
Measured: Post-Assessment (8-10 weeks)
Mindfulness
Pre-assessment to post-assessment difference in score on the Child and Adolescent Mindfulness Measure (CAMM); the CAMM is a 10-item measure of self-reported mindfulness; scores range from 0 to 40, with higher scores indicating higher mindfulness
Measured: Post-Assessment (8-10 weeks)
Overall Improvement
Score on the Clinical Global Impression - Improvement (CGI-I) scale; the CGI-I is a 1 item measure of improvement from pre- to post-intervention, as assessed by a clinician; scores range from 0-7, with lower scores indicating greater improvement
Measured: Post-Assessment (8-10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Feb 2021
- Primary completion29 Oct 2024
- Study completion29 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Yale 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Hedy Kober, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737512
- Sponsor's protocol ID
- 2000020705
- Other IDs
- 1R34AT009887-01A1
- Acronym
- MBAT-C
- Status last verified
- Nov 2024
- First submitted
- 15 Jan 2021
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based ADHD Treatment for Children: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04737512
- Acronym / sponsor ID
- MBAT-C / 2000020705
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, mindfulness, meditation, children, feasibility, acceptability
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Attention-Deficit/Hyperactivity Disorder (ADHD) affects 11% of children and leads to adverse outcomes. Medications, while often effective in reducing certain ADHD symptoms, have many disadvantages, including misuse and side effects. Behavioral interventions do not have these adverse effects, but they are not as effective. Mindfulness is a candidate intervention for ADHD in elementary school children, but has not been systematically and rigorously studied.
This study will evaluate the feasibility and acceptability of Mindfulness-Based ADHD Treatment for Children (MBAT-C). MBAT-C is designed for children at precisely the age when ADHD-relevant neurocognitive systems are developing and clinical symptoms begin to appear. Forty-five children from the New Haven, CT area, ages 7-13, will be recruited to participate in this randomized-controlled feasibility trial that will compare MBAT-C, medication, and a combined intervention.
Detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) affects 11% of American children. ADHD is a source of considerable psychosocial, educational, and neurocognitive impairment. It is co-morbid with multiple psychiatric disorders and poses an economic burden. Pharmacotherapy is often the first-line treatment for children with ADHD, but such medications are associated with adverse effects, including insomnia, loss of appetite, headaches, stomachaches, tics, moodiness, and irritability. Further, concerns about substance misuse and diversion, as well as parental preference, can limit the use and utility of medications. These limitations underscore the urgency of developing behavioral interventions that do not pose such concerns. At this time, however, behavioral treatments for ADHD are generally less effective than pharmacotherapy, emphasizing the need for better non-pharmacologic interventions.
Mindfulness-defined here as nonjudgmentally paying attention to the present moment-is a promising behavioral approach to ADHD treatment, as evidence suggests that mindfulness improves attention in both healthy adults, and those with ADHD. Mindfulness also improves neurocognitive outcomes in children and adolescents, including executive function and attention, suggesting that mindfulness may be an effective treatment for ADHD in young persons.
This is a feasibility study of a novel intervention: Mindfulness-Based ADHD Treatment for Children (MBAT-C). MBAT-C is derived from Mindfulness-Based Stress Reduction (MBSR), a well-known and extensively-studied mindfulness intervention. Unlike all other mindfulness-based interventions, however, MBAT-C is tailored to the needs, abilities, and vulnerabilities of children with ADHD through the use of age-appropriate class length, homework assignments, contemplative practices, and discussion topics. Specifically, MBAT-C includes 16 twice-weekly 30-minute sessions over 8 weeks. Each session includes two brief meditations, discussion, an exercise, and homework.
In this study, 45 children ages 7-13 with ADHD will be randomized into one of three treatment groups: MBAT-C, medication (MED), or a combined intervention (COM).
The aims of the study are as follows:
Aim 1: Evaluate feasibility of MBAT-C
Aim 2. Measure within-group change from pre- to post-treatment on ADHD-relevant outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based ADHD Treatment for Children | Experimental | Behavioral: Mindfulness-Based ADHD Treatment for Children |
| Medication | Active comparator | Biological: Goal-Standard Medication (Treatment as Usual) |
| Combined (MBAT-C + medication) | Active comparator | Behavioral: Mindfulness-Based ADHD Treatment for Children, Biological: Goal-Standard Medication (Treatment as Usual) |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- child of any sex/gender ages 7-13;
- fulfills the Diagnostic Statistical Manual -5 criteria for ADHD (inattentive, hyperactive, or combined);
- speaks English;
- understands the assent form and provides informed assent;
- has parents who understand the consent form and provide informed consent;
Key exclusion criteria (3 listed)
- physical conditions that may preclude participation;
- any conditions contraindicated for ADHD medications, or potential participants taking monoamine-oxidase inhibitors;
- pregnancy.
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 |
|---|---|---|
| Mindfulness-Based ADHD Treatment for ChildrenMBAT-C is derived from Mindfulness-Based Stress Reduction (MBSR), a well-known and extensively-studied mindfulness intervention. Unlike all other mindfulness-based interventions, however, MBAT-C is tailored to the needs, abilities, and vulnerabilities of children with ADHD through the use of age-appropriate class length, homework assignments, contemplative practices, and discussion topics. | Behavioural | Combined (MBAT-C + medication), Mindfulness-Based ADHD Treatment for Children |
| Goal-Standard Medication (Treatment as Usual)Participants will receive gold-standard, non-experimental medication. This treatment arm relies on a step-by-step approach that is designed to mimic pharmacologic treatment-as-usual in the community. The treatment algorithm is as follows: 1. All participants will start with Concerta; Ritalin may be started if the effect of Concerta wears off mid-day; 2. If Concerta +/- Ritalin is ineffective or not tolerated, participants will progress to Vyvanse; Adderall may be started if the effect of Vyvanse wears off mid-day; 3. If Vyvanse +/- Adderall is also ineffective or not tolerated, participants will progress to Kapvay; 4. If Kapvay is ineffective or not tolerated, participants will progress to Intuniv. 5. Alternative combinations of the above medications will be considered if the above combinations are ineffective or otherwise not tolerated. | Biological | Combined (MBAT-C + medication), Medication |
Primary outcome
Recruitment
Time frame: Completion of study (up to 30 months)
Total number of participants enrolled
Recruitment
Time frame: Completion of study (up to 30 months)
Average time from screening to enrollment
Randomization
Time frame: Completion of study (up to 30 months)
Percent of eligible screened participants who enroll and are randomized
Randomization
Time frame: Completion of study (up to 30 months)
Percent of enrolled who attend at least one session
Attendance (MBAT-C Condition)
Time frame: Post-Assessment (8-10 weeks)
Average number of minutes attended
Attendance (Medication Condition)
Time frame: Post-Assessment (8-10 weeks)
Average percent of scheduled medication visits attended
Attendance (Combined Condition)
Time frame: Post-Assessment (8-10 weeks)
Average percent of MBAT-C and medication visits attended
Attendance (Combined Condition)
Time frame: Post-Assessment (8-10 weeks)
Average number of minutes of MBAT-C attended
Medication Adherence (for medication and combined conditions only)
Time frame: Post-Assessment (8-10 weeks)
Average percent of prescribed doses taken
Retention
Time frame: Post-Assessment (8-10 weeks)
Percent of enrolled who attend >60% of study sessions
Participation - Student Rated (for MBAT-C and combined conditions only)
Time frame: Post-Assessment (8-10 weeks)
Average student ratings of participation of each MBAT-C session, as measured by the Research Assessment Package for Schools - Student (RAPS-SE); RAPS-SE is a 6 item measure with individual item scores ranging from 1 to 4; overall score is average of 3 individual items; higher scores indicate higher participation
Participation - Teacher Rated (for MBAT-C and combined conditions only)
Time frame: Post-Assessment (8-10 weeks)
Average teacher ratings of participation of each MBAT-C session, as measured by the Research Assessment Package for Schools - Teacher Engagement (RAPS-TE); RAPS-TE is a 3 item measure of participation with individual item scores ranging from 1 to 4; overall score is average of 3 individual items; higher scores indicate greater participation
Homework Completion (for MBAT-C and combined conditions only)
Time frame: Post-Assessment (8-10 weeks)
Average number of days per week practicing
Homework Completion (for MBAT-C and combined conditions only)
Time frame: Post-Assessment (8-10 weeks)
Average number of total minutes practiced
Acceptability
Time frame: Post-Assessment (8-10 weeks)
Average score on Acceptability of Intervention Measure (AIM); AIM is a 4 item measure of acceptability with individual item scores ranging from 1-4; overall score is sum of individual items; higher scores indicate higher acceptability
8 secondary outcomes
ADHD Symptoms
Time frame: Post-Assessment (8-10 weeks)
Total Problems
Time frame: Post-Assessment (8-10 weeks)
Externalizing Problems
Time frame: Post-Assessment (8-10 weeks)
Attention
Time frame: Post-Assessment (8-10 weeks)
Executive Function
Time frame: Post-Assessment (8-10 weeks)
Working Memory
Time frame: Post-Assessment (8-10 weeks)
Mindfulness
Time frame: Post-Assessment (8-10 weeks)
Overall Improvement
Time frame: Post-Assessment (8-10 weeks)
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 Nov 2024.
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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.
Hedy Kober, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mindfulness-Based ADHD Treatment for Children and Goal-Standard Medication (Treatment as Usual) in people with Attention Deficit Hyperactivity Disorder, run by Yale University at 1 site in United States.
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 8 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 Nov 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Recruitment (time frame: Completion of study (up to 30 months)). The study lists 15 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 Nov 2024.