Autism Spectrum DisorderEASENCT03432832
Emotion Awareness and Skills Enhancement Program
A study testing EASE and Supportive Therapy in people with Autism Spectrum Disorder, run by University of Pittsburgh at 2 sites in United States.
Trial summary
This project will address impaired emotion regulation in adolescents with ASD (autism spectrum disorder). There are no evidence-based interventions to improve emotion regulation (ER) in this population, yet poor emotion regulation often leads to maladaptive behavior and substantially impedes capacity to learn and… Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- EASE and Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jan 2018to 30 Jul 2024
- Phase
- Interventional
- 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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ages 12-21 years, inclusive
- A diagnosis of ASD (autism spectrum disorder), as defined by exceeding the ASD cutoff on the ADOS-2 (Autism Diagnostic Observation Scale) or ADI-R (Autism Diagnostic Interview-Revised) In. If the participant has completed the ADOS in a previous study within 3 years and signs a release of information to obtain it, they will not be required to complete another ADOS.
- Average verbal intellectual ability (Wechsler Abbreviated Scale of Intelligence-2 [WASI-2] FSIQ >=75).
- Fluent in the English language
- Problems with regulating emotions based on parent report 6) Parent/guardian who will attend sessions and assessments.
Who cannot join
- Current concerns of suicidality that warrants immediate clinical care (such potential participants will be referred elsewhere for treatment), determined by clinical interview.
- Previous or current diagnosis of a psychotic disorder.
- Receiving concurrent psychotherapy treatment for emotional issues (i.e., depression, anxiety, anger) that overlaps with the current study. This will be assessed using current treatment items on the demographic forms.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Shannondora Porton
Pittsburgh, Pennsylvania, 15213
University of Alabama
Tuscaloosa, Alabama, 35487
About this study
Official title: Emotion Awareness and Skills Enhancement (EASE) Program: A Clinical Trial
This project will address impaired emotion regulation in adolescents with ASD (autism spectrum disorder). There are no evidence-based interventions to improve emotion regulation (ER) in this population, yet poor emotion regulation often leads to maladaptive behavior and substantially impedes capacity to learn and function across all life settings, and reduce their quality of life and that of their families. The primary objective of this study is to formally evaluate efficacy of EASE via a sufficiently powered, two-site randomized-controlled trial (RCT).
Read the detailed description
The current study is to test a new intervention called Emotional Awareness and Skills Enhancement (EASE). This program was designed to address ASD-specific obstacles to effective emotion regulation, such as reduced awareness concerning others' intentions, a limited repertoire of behavioral responses, and inadequate language for understanding emotional experiences. This new program is based on an acceptance-based approach in which awareness of emotion is developed, emotions (whether negative or positive) are accepted, and behavior is regulated in the face of intense emotion. The goal is not to learn to avoid negative emotions, but rather to develop a collection of abilities which allow the individual to manage stress and act in ways that are more adaptive. The investigators expect to find that participants' emotion dysregulation will decrease and their adaptive function will increase following completion of the EASE program.
- Conditions
- Autism Spectrum Disorder
- Being tested
- EASE, Supportive Therapy
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EASEBehavioural
Weekly behavioral sessions with therapist to work on emotional control through measures such as mindfulness.
Supportive TherapyBehavioural
Weekly behavioral sessions with a therapist to work on emotional control
| Study group | Role | What they receive |
|---|---|---|
| Emotion Awareness/Skills Enhancement | Experimental | EASE Therapy includes 16 weekly sessions focused on mindfulness exercise, review of prior content, practicing prior skills, outline of current session, discussion of the new skill, handouts, practice and plan for out of session practice held in Webster Hall in Pittsburgh, at the Center for the Prevention of Youth Behavior Problems in Tuscaloosa or via telehealth conferencing software. The investigators will apply a multimodal teaching approach, where individual therapy is buttressed by parent involvement and practice sessions in the youth's community. A secure website developed for this project (emotion-Coach or "e-Coach") will augment the intervention by providing online supports to increase treatment intensity or dosage. There will be specific information on how to reinforce the skills at home and in the community. Receives: Behavioral: EASE |
| Supportive Therapy | Active comparator | Supportive Therapy will involve attending 16 weekly therapy sessions held in Webster Hall in Pittsburgh, at the Center for the Prevention of Youth Behavior Problems in Tuscaloosa or via telehealth conferencing software. The intervention will not involve mindfulness or other emotion regulation strategies used in EASE. The therapy will be tailored to the individual's needs and will include aspects common in supportive therapy such as reflective listening, antecedent management, and problem-solving. This program does not have an online component. Receives: Behavioral: Supportive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Clinical Global Impression Scale- Improvement (CGI-I)
The CGI-I will be used as a measure of overall improvement. The CGI-I (Improvement) scale was designed to measure overall symptomatic change at a specific time as compared to baseline that is completed by a rater who is blind to treatment assignment. Scores range from 1 (Very Much Improved) to 4 (Unchanged) to 7 (Very Much Worse). It is only a single item, and lower scores indicate more improvement.
Measured: The CGI-I will be completed at 16 weeks (post-treatment)
Emotion Dysregulation Inventory Reactivity Scale Short Form (EDI-SF)
The EDI SF is a measure of emotional reactivity and regulation. The EDI SF is based on theta scores, with a mean of 0 and SD of 1 and possible range from -1.99 to 2.105. Higher scores suggest greater dysregulation, so improvement would be measured by a decrease in scores.
Measured: The EDI-SF will be completed at 16 weeks (post-treatment).
Secondary outcomes (1)
Brief Psychiatric Rating Scale (BPRS)
The Brief Psychiatric Rating Scale (BPRS) is an interview-based measure of psychopathology severity widely used in clinical trials. It consists of 24 items that measure psychiatric symptoms, each of which are on a 1 (not reported) to 7 (very severe) scale, so that lower scores are an indication of improvement. An assignment naïve rater scores the items based upon client report and clinical observation. All scales ask about symptoms over the last 7 days. The single item on "Global Improvement" will be used.
Measured: The CGI-I will be completed at 16 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start30 Jan 2018
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- per protocol analysis versus intent to treat analytic approach due to the pandemic
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Principal investigator, Carla Mazefsky, University of Pittsburgh
- Investigators
- Carla Mazefsky, PhD, Principal investigator, University of PittsburghSusan White, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432832
- Sponsor's protocol ID
- STUDY20110317
- Acronym
- EASE
- Status last verified
- Apr 2025
- First submitted
- 17 Jan 2018
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abidin, R. R. (2012). Parenting Stress Index, Fourth Edition Short Form (PSI-4). Lutz, FL: PAR.
Achenbach, T. M., & Rescorla, L. (2001). Manual for the ASEBA school-age forms and profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.
Aldao A, Nolen-Hoeksema S, Schweizer S. Emotion-regulation strategies across psychopathology: A meta-analytic review. Clin Psychol Rev. 2010 Mar;30(2):217-37. doi: 10.1016/j.cpr.2009.11.004. Epub 2009 Nov 20.
PubMed 20015584Aman MG, Singh NN, Stewart AW, Field CJ. The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects. Am J Ment Defic. 1985 Mar;89(5):485-91.
PubMed 3993694Aman M, Rettiganti M, Nagaraja HN, Hollway JA, McCracken J, McDougle CJ, Tierney E, Scahill L, Arnold LE, Hellings J, Posey DJ, Swiezy NB, Ghuman J, Grados M, Shah B, Vitiello B. Tolerability, Safety, and Benefits of Risperidone in Children and Adolescents with Autism: 21-Month Follow-up After 8-Week Placebo-Controlled Trial. J Child Adolesc Psychopharmacol. 2015 Aug;25(6):482-93. doi: 10.1089/cap.2015.0005.
PubMed 26262903Anagnostou E, Jones N, Huerta M, Halladay AK, Wang P, Scahill L, Horrigan JP, Kasari C, Lord C, Choi D, Sullivan K, Dawson G. Measuring social communication behaviors as a treatment endpoint in individuals with autism spectrum disorder. Autism. 2015 Jul;19(5):622-36. doi: 10.1177/1362361314542955. Epub 2014 Aug 5.
PubMed 25096930Anderson DK, Liang JW, Lord C. Predicting young adult outcome among more and less cognitively able individuals with autism spectrum disorders. J Child Psychol Psychiatry. 2014 May;55(5):485-94. doi: 10.1111/jcpp.12178. Epub 2013 Dec 9.
PubMed 24313878Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.
PubMed 10842426Baker AE, Lane A, Angley MT, Young RL. The relationship between sensory processing patterns and behavioural responsiveness in autistic disorder: a pilot study. J Autism Dev Disord. 2008 May;38(5):867-75. doi: 10.1007/s10803-007-0459-0.
PubMed 17899349Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. doi: 10.1037//0022-3514.51.6.1173.
PubMed 3806354Baskin TW, Tierney SC, Minami T, Wampold BE. Establishing specificity in psychotherapy: a meta-analysis of structural equivalence of placebo controls. J Consult Clin Psychol. 2003 Dec;71(6):973-9. doi: 10.1037/0022-006X.71.6.973.
PubMed 14622072Bishop-Fitzpatrick L, Minshew NJ, Eack SM. A systematic review of psychosocial interventions for adults with autism spectrum disorders. J Autism Dev Disord. 2013 Mar;43(3):687-94. doi: 10.1007/s10803-012-1615-8.
PubMed 22825929Boulter C, Freeston M, South M, Rodgers J. Intolerance of uncertainty as a framework for understanding anxiety in children and adolescents with autism spectrum disorders. J Autism Dev Disord. 2014 Jun;44(6):1391-402. doi: 10.1007/s10803-013-2001-x.
PubMed 24272526Carroll D, Hallett V, McDougle CJ, Aman MG, McCracken JT, Tierney E, Arnold LE, Sukhodolsky DG, Lecavalier L, Handen BL, Swiezy N, Johnson C, Bearss K, Vitiello B, Scahill L. Examination of aggression and self-injury in children with autism spectrum disorders and serious behavioral problems. Child Adolesc Psychiatr Clin N Am. 2014 Jan;23(1):57-72. doi: 10.1016/j.chc.2013.08.002.
PubMed 24231167Autism and Developmental Disabilities Monitoring Network Surveillance Year 2008 Principal Investigators; Centers for Disease Control and Prevention. Prevalence of autism spectrum disorders--Autism and Developmental Disabilities Monitoring Network, 14 sites, United States, 2008. MMWR Surveill Summ. 2012 Mar 30;61(3):1-19.
PubMed 22456193
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Awareness and Skills Enhancement (EASE) Program: A Clinical Trial
- ClinicalTrials.gov ID
- NCT03432832
- Acronym / sponsor ID
- EASE / STUDY20110317
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 14 Feb 2018 (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.
This project will address impaired emotion regulation in adolescents with ASD (autism spectrum disorder). There are no evidence-based interventions to improve emotion regulation (ER) in this population, yet poor emotion regulation often leads to maladaptive behavior and substantially impedes capacity to learn and function across all life settings, and reduce their quality of life and that of their families. The primary objective of this study is to formally evaluate efficacy of EASE via a sufficiently powered, two-site randomized-controlled trial (RCT).
Detailed description
The current study is to test a new intervention called Emotional Awareness and Skills Enhancement (EASE). This program was designed to address ASD-specific obstacles to effective emotion regulation, such as reduced awareness concerning others' intentions, a limited repertoire of behavioral responses, and inadequate language for understanding emotional experiences. This new program is based on an acceptance-based approach in which awareness of emotion is developed, emotions (whether negative or positive) are accepted, and behavior is regulated in the face of intense emotion. The goal is not to learn to avoid negative emotions, but rather to develop a collection of abilities which allow the individual to manage stress and act in ways that are more adaptive. The investigators expect to find that participants' emotion dysregulation will decrease and their adaptive function will increase following completion of the EASE program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- per protocol analysis versus intent to treat analytic approach due to the pandemic
| Arm | Type | Receives |
|---|---|---|
| Emotion Awareness/Skills Enhancement | Experimental | Behavioral: EASEEASE Therapy includes 16 weekly sessions focused on mindfulness exercise, review of prior content, practicing prior skills, outline of current session, discussion of the new skill, handouts, practice and plan for out of session practice held in Webster Hall in Pittsburgh, at the Center for the Prevention of Youth Behavior Problems in Tuscaloosa or via telehealth conferencing software. The investigators will apply a multimodal teaching approach, where individual therapy is buttressed by parent involvement and practice sessions in the youth's community. A secure website developed for this project (emotion-Coach or "e-Coach") will augment the intervention by providing online supports to increase treatment intensity or dosage. There will be specific information on how to reinforce the skills at home and in the community. |
| Supportive Therapy | Active comparator | Behavioral: Supportive TherapySupportive Therapy will involve attending 16 weekly therapy sessions held in Webster Hall in Pittsburgh, at the Center for the Prevention of Youth Behavior Problems in Tuscaloosa or via telehealth conferencing software. The intervention will not involve mindfulness or other emotion regulation strategies used in EASE. The therapy will be tailored to the individual's needs and will include aspects common in supportive therapy such as reflective listening, antecedent management, and problem-solving. This program does not have an online component. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- ages 12-21 years, inclusive
- A diagnosis of ASD (autism spectrum disorder), as defined by exceeding the ASD cutoff on the ADOS-2 (Autism Diagnostic Observation Scale) or ADI-R (Autism Diagnostic Interview-Revised) In. If the participant has completed the ADOS in a previous study within 3 years and signs a release of information to obtain it, they will not be required to complete another ADOS.
- Average verbal intellectual ability (Wechsler Abbreviated Scale of Intelligence-2 [WASI-2] FSIQ >=75).
- Fluent in the English language
- Problems with regulating emotions based on parent report 6) Parent/guardian who will attend sessions and assessments.
Key exclusion criteria (3 listed)
- Current concerns of suicidality that warrants immediate clinical care (such potential participants will be referred elsewhere for treatment), determined by clinical interview.
- Previous or current diagnosis of a psychotic disorder.
- Receiving concurrent psychotherapy treatment for emotional issues (i.e., depression, anxiety, anger) that overlaps with the current study. This will be assessed using current treatment items on the demographic forms.
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 |
|---|---|---|
| EASEWeekly behavioral sessions with therapist to work on emotional control through measures such as mindfulness. | Behavioural | Emotion Awareness/Skills Enhancement |
| Supportive TherapyWeekly behavioral sessions with a therapist to work on emotional control | Behavioural | Supportive Therapy |
Primary outcome
The Clinical Global Impression Scale- Improvement (CGI-I)
Time frame: The CGI-I will be completed at 16 weeks (post-treatment)
The CGI-I will be used as a measure of overall improvement. The CGI-I (Improvement) scale was designed to measure overall symptomatic change at a specific time as compared to baseline that is completed by a rater who is blind to treatment assignment. Scores range from 1 (Very Much Improved) to 4 (Unchanged) to 7 (Very Much Worse). It is only a single item, and lower scores indicate more improvement.
Emotion Dysregulation Inventory Reactivity Scale Short Form (EDI-SF)
Time frame: The EDI-SF will be completed at 16 weeks (post-treatment).
The EDI SF is a measure of emotional reactivity and regulation. The EDI SF is based on theta scores, with a mean of 0 and SD of 1 and possible range from -1.99 to 2.105. Higher scores suggest greater dysregulation, so improvement would be measured by a decrease in scores.
1 secondary outcome
Brief Psychiatric Rating Scale (BPRS)
Time frame: The CGI-I will be completed at 16 weeks (post-treatment)
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 17 Apr 2025.
- BackgroundAbidin, R. R. (2012). Parenting Stress Index, Fourth Edition Short Form (PSI-4). Lutz, FL: PAR.
- BackgroundAchenbach, T. M., & Rescorla, L. (2001). Manual for the ASEBA school-age forms and profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.
- Background: PubMed 20015584Aldao A, Nolen-Hoeksema S, Schweizer S. Emotion-regulation strategies across psychopathology: A meta-analytic review. Clin Psychol Rev. 2010 Mar;30(2):217-37. doi: 10.1016/j.cpr.2009.11.004. Epub 2009 Nov 20.
- Background: PubMed 3993694Aman MG, Singh NN, Stewart AW, Field CJ. The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects. Am J Ment Defic. 1985 Mar;89(5):485-91.
- Background: PubMed 26262903Aman M, Rettiganti M, Nagaraja HN, Hollway JA, McCracken J, McDougle CJ, Tierney E, Scahill L, Arnold LE, Hellings J, Posey DJ, Swiezy NB, Ghuman J, Grados M, Shah B, Vitiello B. Tolerability, Safety, and Benefits of Risperidone in Children and Adolescents with Autism: 21-Month Follow-up After 8-Week Placebo-Controlled Trial. J Child Adolesc Psychopharmacol. 2015 Aug;25(6):482-93. doi: 10.1089/cap.2015.0005.
- Background: PubMed 25096930Anagnostou E, Jones N, Huerta M, Halladay AK, Wang P, Scahill L, Horrigan JP, Kasari C, Lord C, Choi D, Sullivan K, Dawson G. Measuring social communication behaviors as a treatment endpoint in individuals with autism spectrum disorder. Autism. 2015 Jul;19(5):622-36. doi: 10.1177/1362361314542955. Epub 2014 Aug 5.
- Background: PubMed 24313878Anderson DK, Liang JW, Lord C. Predicting young adult outcome among more and less cognitively able individuals with autism spectrum disorders. J Child Psychol Psychiatry. 2014 May;55(5):485-94. doi: 10.1111/jcpp.12178. Epub 2013 Dec 9.
- Background: PubMed 10842426Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.
- Background: PubMed 17899349Baker AE, Lane A, Angley MT, Young RL. The relationship between sensory processing patterns and behavioural responsiveness in autistic disorder: a pilot study. J Autism Dev Disord. 2008 May;38(5):867-75. doi: 10.1007/s10803-007-0459-0.
- Background: PubMed 3806354Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. doi: 10.1037//0022-3514.51.6.1173.
- Background: PubMed 14622072Baskin TW, Tierney SC, Minami T, Wampold BE. Establishing specificity in psychotherapy: a meta-analysis of structural equivalence of placebo controls. J Consult Clin Psychol. 2003 Dec;71(6):973-9. doi: 10.1037/0022-006X.71.6.973.
- Background: PubMed 22825929Bishop-Fitzpatrick L, Minshew NJ, Eack SM. A systematic review of psychosocial interventions for adults with autism spectrum disorders. J Autism Dev Disord. 2013 Mar;43(3):687-94. doi: 10.1007/s10803-012-1615-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Mazefsky, PhD principal investigator
University of Pittsburgh
Susan White principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EASE and Supportive Therapy in people with Autism Spectrum Disorder, run by University of Pittsburgh at 2 sites 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 5 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 17 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 2 sites 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.
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?
The Clinical Global Impression Scale- Improvement (CGI-I) (time frame: The CGI-I will be completed at 16 weeks (post-treatment)). The study lists 2 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 NCT03432832, which also lists 54 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 17 Apr 2025.