Difficulties of Emotion RegulationNCT07021274
DBT Skill Training for Autistic Adults With Difficulties in Emotion Regulation.
A study testing DBT skills training adjusted to autistic needs in people with Difficulties of Emotion Regulation and Self-harm Behavior, run by Helse Møre og Romsdal HF at 1 site in Norway.
Trial summary
One in 44 has autism, 70% of them have additional mental health challenges. Currently, this patient population does not have access to effective treatment within specialist healthcare services and has struggled to benefit from standard treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficulties of Emotion Regulation, Self-harm Behavior, Autism Spectrum Disorder
- What is being tested?
- DBT skills training adjusted to autistic needs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- 15 Aug 2025to 28 Feb 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fit general inclusion criteria for the out- patient treatment at the clinic.
- Have diagnosed autism, and pervasive difficulties in emotion regulation.
- Speak Scandinavian (Norwegian, Danish and/or Swedish).
- Manage to commit to participating in the DBT- skills training.
- Be willing to sign the written informed consent.
Who cannot join
- Have a clinically significant low linguistic functioning that hinders the patient in understanding and answering the questions on the self-report instruments.
- Being actively psychotic.
- Have a Body Mass Index (BMI) under 17.
- Cognitive disability Intelliganve quotient (IQ) <85
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Outpatient psychiatric unit - More and Romsdal Health Trust
Molde, 6416
Johanna Vigfusdottir Vigfusdottir, +4746746154, johanna.vigfusdottir@helse-mr.no
About this study
Official title: DBT Skill Training for Autistic Adults With Difficulties in Emotion Regulation: a Feasibility Study.
One in 44 has autism, 70% of them have additional mental health challenges. Currently, this patient population does not have access to effective treatment within specialist healthcare services and has struggled to benefit from standard treatments. The goal of this project is to increase access to treatment tailored to their challenges. We will investigate whether a treatment program with an adapted version of Dialectical Behavior Therapy (DBT) is feasible, accepted, and perceived as useful for people with autism. The purpose of the treatment is to improve emotion regulation, function better in relationships, and avoid crises, thereby enhancing their ability to achieve personal goals, reduce suffering, and increase quality of life. Autism is a lifelong neurodevelopmental disorder, presenting with great variation and more widespread than previously thought. Difficulties with emotion regulation are a central challenge for many with autism. These difficulties often manifest as an inability to recognize, understand, and manage emotional responses, leading to destructive strategies, behaviors, and suffering. DBT is developed with a focus on emotion regulation and has shown good effects in other patient populations. The project can increase access to treatment for a patient population that currently stands without.
Read the detailed description
Autism Spectrum Disorder (ASD) is a lifelong neurodevelopmental condition marked by difficulties in social interaction, communication, sensory sensitivities, and repetitive behaviors. ASD varies widely among individuals and has become more recognized over time. The prevalence of ASD has significantly increased, with the U.S Centers for Disease Control and Prevention (CDC) reporting a rise from 1 in 2,222 children in 1968 to 1 in 44 children in 2020. This increase is due to evolving definitions, greater awareness, and differences in study methodologies.
Many individuals with ASD, especially those without intellectual disabilities, often remain undiagnosed until adulthood. Undiagnosed ASD is common in adult clinical populations, with a Swedish study finding that 18.9% of psychiatric outpatients had ASD. Psychiatric comorbidities are frequent in ASD, including anxiety, depression, attention deficit hyperactity disorder (ADHD), obsessive compulsive disorder (OCD), bipolar disorders, and sleep-wake disorders, complicating diagnosis and treatment. Autistic individuals often engage in suicidal behaviors, self-harm, and aggression, impacting daily life.
Autistic women without intellectual disabilities are often underdiagnosed due to less overt symptoms and their ability to camouflage difficulties. Misdiagnosis with personality disorders, particularly borderline personality disorder, is common.
Despite rising diagnosis rates, there is a lack of evidence-based treatment options for autistic adults, especially for those with comorbid mental disorders. Many clinicians lack training to work with autistic adults, and ASD specialists often lack expertise in treating co-occurring conditions. In Norway, there is a significant gap in treatment options for autistic adults without intellectual disabilities.
Emotion regulation difficulties are central challenges for many autistic adults, involving physiological arousal, brain region alterations, and unique ASD mechanisms like cognitive rigidity. Autistic adults often struggle with alexithymia, exacerbating emotion regulation issues. Developing effective emotion regulation strategies can improve quality of life.
Dialectical Behavior Therapy (DBT) helps autistic individuals manage emotions, relationships, and crises. DBT has shown effectiveness in reducing self-harm and suicidal behaviors among autistic adults. A study in North Carolina found DBT skills training feasible and acceptable for autistic adults without intellectual impairment. Similar studies have not been conducted in Nordic countries for outpatient psychiatric settings.
This study is a mixed-method feasibility study without a control group. With measurements pre and post treatment intervention. In the project period approximatly 15 patients will be invited to participate, referred to the project by a therapist form an general outpatient psychiatric clinic.
Primary objectives
If the DBT-skills training is relevant - The severity of difficulties in emotion regulation for the population, and the presences of destructive behaviour such as self-harm and suicide behaviour.
If DBT-skills training is accepted by tracking the dropout rate from DBT skills training, as well as the percentage of DBT-SUD skills sessions participated in, and the percentage completed homework.
Acceptability and Feasibility post treatment by evaluating participants' experiences with the treatment, and use of unhelpful and helpful strategies with self-rapport instruments.
Secondary objectives
Tracking the change in two target behaviors and four target emotions and use of skills in the treatment period with a diary card.
Assessing goals, hinders, and resources at the start and completion of the DBT skills training, with a qualitative interview.
Strength and limitations
Strength: This is a feasibility study in naturalistic treatment, making the results generalizable.
The result of the study gives relevant information in a population that is often excluded from studies because of ASD diagnosis.
Limitations: With a lack of a randomized control group, one cannot measure the direct effect of the intervention.
Future research: If the intervention fits the progression criteria and proves to be relevant, feasible, acceptable, and of potential benefit for the patients, the future aim is to conduct a Randomized Control Trial (RCT) on the effect of DBT skills training for autistic adults with difficulties in emotion regulation.
- Being tested
- DBT skills training adjusted to autistic needs
- Keywords
- Autisim, emotion regulation, DBT skills training, adults, ASD, Feasibility, Autism spectrum disorder
- Medical subject headings
- Autism Spectrum Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT skills training adjusted to autistic needsBehavioural
Adjustments to fit the specific learning style of people with autism. Simplified skills - fewer words, ,more pictures, autism relevant examples. Hands- on training using props and role play. adjustments so sensory sensitivities.
| Study group | Role | What they receive |
|---|---|---|
| Participate in DBT skills training | Experimental | The intervention period will be from August 2025- February 2027.
DBT- skills is a group skills training component of Dialectical Behaviour therapy a comprehensive treatment focused on extensive difficulties in emotion regulation. In this project, the investigators will use the standard DBT skill-training model with an addition of Autism specific interventions and adjustments.
The DBT-SUD Skills intervention consists of:
2-3 sessions with a DBT therapist focusing on treatment orientation - mapping the patients' goals, obstacles, and resources, DBT- hierarchy, and commitment.
Skills training - 28, two-hour sessions - once a week.
1 status and evaluation session half-way through the skills training.
1 summary session with a focus on goals reached and troubleshooting.
Two DBT therapists lead the group, and each group consists of approx. 4-6 participants. Receives: Behavioral: DBT skills training adjusted to autistic needs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulties in emotion regulation scale (DERS) - 8
a shortened self-report instrument, developed from the original DERS-36 meant to measure difficulties in emotion regulation. The DERS-8 consists of 8 items prefaced with the phrase "When I'm upset," to provide respondents with a uniform context that elicits thinking about situations requiring regulation of negative emotion; answers to items likely to represent affect, thought, and actions in response to such situations. The scale offers a brief unidimensional measure of difficulties in emotion regulation for adolescents and adults. Higher scores indicate greater levels of difficulties in emotion regulation.
Measured: From enrollment to the end of treatment at 28 weeks.
participation in treatment
Dropout rate from DBT skills training, as well as the percentage of DBT-SUD skills sessions participated in, and the percentage completed homework.
Measured: From enrollment to the end of treatment at 28 weeks.
Dialectical Behavior Therapy- Ways of Coping Checklist (DBT-WCCL)
It is a 59 item self-rapport questionnaire that assesses both positive and negative methods of coping with stressful situations including problem-focus, seeking social support, blaming self, blaming others, wishful thinking, and avoidance as well as DBT skills use on 4-point likert scale: 0 = Never Used, 1= Rarely Used, 2= Sometimes Used, 3 = Regularly Used. The questionnaire is divided into 2 subscales: 1) DBT skills subscale that consists of Nine items represent emotion regulation skills, seven represent interpersonal effectiveness skills, five depict mindfulness skills, 19 represent crisis survival skills, two depict reality acceptance skills (0-114). and 2) Dysfunctional Coping Subscale that consist of 17 items referring to dysfunctional behavior in general along with items referring more specifically to blaming others (0-63).
Measured: From enrollment to the end of treatment at 28 weeks.
Secondary outcomes (2)
Diary card
Tracking the change in two target behaviours and four target emotions and use of skills in the treatment period with a diary card.
Measured: From enrollment to the end of treatment at 28 weeks.
Qualitative interview guide - DBT skills training ASD
Qualitative interview focusing on the participants goals, hinders and resources, and how they experienced the treatment interventions in relation to achieving these goals.
Measured: From enrollment to the end of treatment at 28 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start15 Aug 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Difficulties of Emotion RegulationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a mixed-method feasibility study without a control group. With measurements pre and post treatment intervention
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Møre og Romsdal HF
- Sponsor type
- Other government
- Collaborators
- The Dam Foundation
- Responsible party
- Sponsor
- Investigators
- Egil Jonsbu, MD, PhD, Study director, More And Romsdal Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021274
- Sponsor's protocol ID
- 836937
- Status last verified
- Oct 2026
- First submitted
- 19 May 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bargiela S, Steward R, Mandy W. The Experiences of Late-diagnosed Women with Autism Spectrum Conditions: An Investigation of the Female Autism Phenotype. J Autism Dev Disord. 2016 Oct;46(10):3281-94. doi: 10.1007/s10803-016-2872-8.
PubMed 27457364Ritschel LA, Guy L, Maddox BB. A pilot study of dialectical behaviour therapy skills training for autistic adults. Behav Cogn Psychother. 2022 Mar;50(2):187-202. doi: 10.1017/S1352465821000370. Epub 2021 Sep 23.
PubMed 34553682
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DBT Skill Training for Autistic Adults With Difficulties in Emotion Regulation: a Feasibility Study.
- ClinicalTrials.gov ID
- NCT07021274
- Acronym / sponsor ID
- 836937
- Keywords
- Autisim, emotion regulation, DBT skills training, adults, ASD, Feasibility, Autism spectrum disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Helse Møre og Romsdal HFOther government
- Collaborators
- The Dam Foundation
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 13 Jun 2025 (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.
One in 44 has autism, 70% of them have additional mental health challenges. Currently, this patient population does not have access to effective treatment within specialist healthcare services and has struggled to benefit from standard treatments. The goal of this project is to increase access to treatment tailored to their challenges. We will investigate whether a treatment program with an adapted version of Dialectical Behavior Therapy (DBT) is feasible, accepted, and perceived as useful for people with autism. The purpose of the treatment is to improve emotion regulation, function better in relationships, and avoid crises, thereby enhancing their ability to achieve personal goals, reduce suffering, and increase quality of life. Autism is a lifelong neurodevelopmental disorder, presenting with great variation and more widespread than previously thought. Difficulties with emotion regulation are a central challenge for many with autism. These difficulties often manifest as an inability to recognize, understand, and manage emotional responses, leading to destructive strategies, behaviors, and suffering. DBT is developed with a focus on emotion regulation and has shown good effects in other patient populations. The project can increase access to treatment for a patient population that currently stands without.
Detailed description
Autism Spectrum Disorder (ASD) is a lifelong neurodevelopmental condition marked by difficulties in social interaction, communication, sensory sensitivities, and repetitive behaviors. ASD varies widely among individuals and has become more recognized over time. The prevalence of ASD has significantly increased, with the U.S Centers for Disease Control and Prevention (CDC) reporting a rise from 1 in 2,222 children in 1968 to 1 in 44 children in 2020. This increase is due to evolving definitions, greater awareness, and differences in study methodologies.
Many individuals with ASD, especially those without intellectual disabilities, often remain undiagnosed until adulthood. Undiagnosed ASD is common in adult clinical populations, with a Swedish study finding that 18.9% of psychiatric outpatients had ASD. Psychiatric comorbidities are frequent in ASD, including anxiety, depression, attention deficit hyperactity disorder (ADHD), obsessive compulsive disorder (OCD), bipolar disorders, and sleep-wake disorders, complicating diagnosis and treatment. Autistic individuals often engage in suicidal behaviors, self-harm, and aggression, impacting daily life.
Autistic women without intellectual disabilities are often underdiagnosed due to less overt symptoms and their ability to camouflage difficulties. Misdiagnosis with personality disorders, particularly borderline personality disorder, is common.
Despite rising diagnosis rates, there is a lack of evidence-based treatment options for autistic adults, especially for those with comorbid mental disorders. Many clinicians lack training to work with autistic adults, and ASD specialists often lack expertise in treating co-occurring conditions. In Norway, there is a significant gap in treatment options for autistic adults without intellectual disabilities.
Emotion regulation difficulties are central challenges for many autistic adults, involving physiological arousal, brain region alterations, and unique ASD mechanisms like cognitive rigidity. Autistic adults often struggle with alexithymia, exacerbating emotion regulation issues. Developing effective emotion regulation strategies can improve quality of life.
Dialectical Behavior Therapy (DBT) helps autistic individuals manage emotions, relationships, and crises. DBT has shown effectiveness in reducing self-harm and suicidal behaviors among autistic adults. A study in North Carolina found DBT skills training feasible and acceptable for autistic adults without intellectual impairment. Similar studies have not been conducted in Nordic countries for outpatient psychiatric settings.
This study is a mixed-method feasibility study without a control group. With measurements pre and post treatment intervention. In the project period approximatly 15 patients will be invited to participate, referred to the project by a therapist form an general outpatient psychiatric clinic.
Primary objectives
If the DBT-skills training is relevant - The severity of difficulties in emotion regulation for the population, and the presences of destructive behaviour such as self-harm and suicide behaviour.
If DBT-skills training is accepted by tracking the dropout rate from DBT skills training, as well as the percentage of DBT-SUD skills sessions participated in, and the percentage completed homework.
Acceptability and Feasibility post treatment by evaluating participants' experiences with the treatment, and use of unhelpful and helpful strategies with self-rapport instruments.
Secondary objectives
Tracking the change in two target behaviors and four target emotions and use of skills in the treatment period with a diary card.
Assessing goals, hinders, and resources at the start and completion of the DBT skills training, with a qualitative interview.
Strength and limitations
Strength: This is a feasibility study in naturalistic treatment, making the results generalizable.
The result of the study gives relevant information in a population that is often excluded from studies because of ASD diagnosis.
Limitations: With a lack of a randomized control group, one cannot measure the direct effect of the intervention.
Future research: If the intervention fits the progression criteria and proves to be relevant, feasible, acceptable, and of potential benefit for the patients, the future aim is to conduct a Randomized Control Trial (RCT) on the effect of DBT skills training for autistic adults with difficulties in emotion regulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a mixed-method feasibility study without a control group. With measurements pre and post treatment intervention
| Arm | Type | Receives |
|---|---|---|
| Participate in DBT skills training | Experimental | Behavioral: DBT skills training adjusted to autistic needsThe intervention period will be from August 2025- February 2027. DBT- skills is a group skills training component of Dialectical Behaviour therapy a comprehensive treatment focused on extensive difficulties in emotion regulation. In this project, the investigators will use the standard DBT skill-training model with an addition of Autism specific interventions and adjustments. The DBT-SUD Skills intervention consists of: 2-3 sessions with a DBT therapist focusing on treatment orientation - mapping the patients' goals, obstacles, and resources, DBT- hierarchy, and commitment. Skills training - 28, two-hour sessions - once a week. 1 status and evaluation session half-way through the skills training. 1 summary session with a focus on goals reached and troubleshooting. Two DBT therapists lead the group, and each group consists of approx. 4-6 participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fit general inclusion criteria for the out- patient treatment at the clinic.
- Have diagnosed autism, and pervasive difficulties in emotion regulation.
- Speak Scandinavian (Norwegian, Danish and/or Swedish).
- Manage to commit to participating in the DBT- skills training.
- Be willing to sign the written informed consent.
Key exclusion criteria (4 listed)
- Have a clinically significant low linguistic functioning that hinders the patient in understanding and answering the questions on the self-report instruments.
- Being actively psychotic.
- Have a Body Mass Index (BMI) under 17.
- Cognitive disability Intelliganve quotient (IQ) <85
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 |
|---|---|---|
| DBT skills training adjusted to autistic needsAdjustments to fit the specific learning style of people with autism. Simplified skills - fewer words, ,more pictures, autism relevant examples. Hands- on training using props and role play. adjustments so sensory sensitivities. | Behavioural | Participate in DBT skills training |
Primary outcome
Difficulties in emotion regulation scale (DERS) - 8
Time frame: From enrollment to the end of treatment at 28 weeks.
a shortened self-report instrument, developed from the original DERS-36 meant to measure difficulties in emotion regulation. The DERS-8 consists of 8 items prefaced with the phrase "When I'm upset," to provide respondents with a uniform context that elicits thinking about situations requiring regulation of negative emotion; answers to items likely to represent affect, thought, and actions in response to such situations. The scale offers a brief unidimensional measure of difficulties in emotion regulation for adolescents and adults. Higher scores indicate greater levels of difficulties in emotion regulation.
participation in treatment
Time frame: From enrollment to the end of treatment at 28 weeks.
Dropout rate from DBT skills training, as well as the percentage of DBT-SUD skills sessions participated in, and the percentage completed homework.
Dialectical Behavior Therapy- Ways of Coping Checklist (DBT-WCCL)
Time frame: From enrollment to the end of treatment at 28 weeks.
It is a 59 item self-rapport questionnaire that assesses both positive and negative methods of coping with stressful situations including problem-focus, seeking social support, blaming self, blaming others, wishful thinking, and avoidance as well as DBT skills use on 4-point likert scale: 0 = Never Used, 1= Rarely Used, 2= Sometimes Used, 3 = Regularly Used. The questionnaire is divided into 2 subscales: 1) DBT skills subscale that consists of Nine items represent emotion regulation skills, seven represent interpersonal effectiveness skills, five depict mindfulness skills, 19 represent crisis survival skills, two depict reality acceptance skills (0-114). and 2) Dysfunctional Coping Subscale that consist of 17 items referring to dysfunctional behavior in general along with items referring more specifically to blaming others (0-63).
2 secondary outcomes
Diary card
Time frame: From enrollment to the end of treatment at 28 weeks.
Qualitative interview guide - DBT skills training ASD
Time frame: From enrollment to the end of treatment at 28 weeks.
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 13 Oct 2026.
- Background: PubMed 27457364Bargiela S, Steward R, Mandy W. The Experiences of Late-diagnosed Women with Autism Spectrum Conditions: An Investigation of the Female Autism Phenotype. J Autism Dev Disord. 2016 Oct;46(10):3281-94. doi: 10.1007/s10803-016-2872-8.
- Background: PubMed 34553682Ritschel LA, Guy L, Maddox BB. A pilot study of dialectical behaviour therapy skills training for autistic adults. Behav Cogn Psychother. 2022 Mar;50(2):187-202. doi: 10.1017/S1352465821000370. Epub 2021 Sep 23.
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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.
Egil Jonsbu, MD, PhD study director
More And Romsdal Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT skills training adjusted to autistic needs in people with Difficulties of Emotion Regulation and Self-harm Behavior, run by Helse Møre og Romsdal HF at 1 site in Norway.
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 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. 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 Norway. 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 Johanna Vigfusdottir, Clinical psychologist (+4746746154, johannavigfusd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties in emotion regulation scale (DERS) - 8 (time frame: From enrollment to the end of treatment at 28 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07021274, which also lists 2 linked publications.
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 13 Oct 2026.