Autism Spectrum DisorderPhase 2NCT04047355

Propranolol for Challenging Behaviors in Autism

A Phase 2 study testing Propranolol in people with Autism Spectrum Disorder and Developmental Disability, run by Rutgers, The State University of New Jersey at 1 site in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 12 to 30 years
Conditions the study is for: Autism Spectrum Disorder, Developmental Disability, Aggression
What is being tested?: Propranolol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 11 Feb 2021to 30 Sep 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 30 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Males and females between the ages of 12-30 years and is a resident in the state of New Jersey.
Diagnosis of autism conducted by a clinician with confirmation using the Autism Diagnostic Observation Schedule (ADOS) or the Social Communication Questionnaire (SCQ).
At least one of the following challenging behaviors.
Self-injurious behaviors (e.g., hitting one's self, head banging or banging of other body parts causing some degree of tissue damage);
Physical aggression towards others (e.g., hitting, kicking, pushing, or throwing objects at others);
Disruptive behaviors including property destruction during anger episodes, excessive screaming which interferes with functioning; and

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The challenging behaviors are generally (but not necessarily exclusively) associated with a congruent affect (i.e. anger or rage when aggressing) as determined by the study psychiatrist.
Pharmacologic treatment with at least two psychotropic including one antipsychotic medication has yielded inadequate outcome (partial improvement on one or more medications is acceptable for the study).
Clinical Global Impression Severity scale score of 6 or 7.
Aberrant Behavior Checklist--Community Irritability scale score at or above 18.
Medical and cardiac clearance.

Who cannot join

Asthma or any history of asthma or any disorder involving bronchoconstriction.
Cardiac Diseases in which the use of propranolol at high doses would be contraindicated.
Uncontrolled Seizure disorder (participant had a seizure within the past year and/or changes in seizure medication in the previous six months).
Diabetes or a history of ketoacidosis.
Any other medical disorder or medication which would contraindicate the use of propranolol.
History of allergy or adverse reaction to propranolol.
Pregnancy.
Medication exclusions include clonidine/guanfacine / digoxin or other medications affecting blood pressure.

Trial locations and contacts

1 site in 1 country.

United States1 site

Department of Pediatrics, Division of Pediatric Neurology, Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901

Other trials in United States

About this study

Official title: A Pilot/Feasibility Study of the Use of High Dose Propranolol to Treat Severe and Chronic Challenging Behaviors in Adolescents and Adults With Autism Spectrum Disorders

Severe challenging behaviors such as aggression and self-injury can cause significant morbidity and decrease the quality of life for individuals with Autism Spectrum Disorders (ASD). There are only two medications (Risperdal and Abilify) rigorously studied and FDA-approved for the treatment of irritability in individuals with ASD. These medications are not always successful and have many short and long-term side effects. Well-designed studies demonstrating efficacy and safety of alternative medication treatment choices are needed. There is preliminary evidence that high-dose propranolol can be effective in individuals with ASD who display severe aggression and have not responded to antipsychotics or mood stabilizers. Concerns regarding the safety of high dose propranolol have limited its clinical application. Well-designed clinical trials demonstrating the efficacy and safety of high dose propranolol will have significant effects on clinical practice and improve the physical and behavioral quality of life for an underserved subset of individuals with ASD.

This study will pilot the safety and efficacy of high dose propranolol. The investigators will randomly assign participants to either propranolol or to placebo later crossing each participant over to the other group. As propranolol can cause changes in blood pressure and heart function, each participant will complete initial comprehensive testing to monitor cardiac safety throughout the study. The investigators will be utilizing telemedicine and computer based telemetry to minimize the burden of office visits on the individual and family.

Read the detailed description

This is a randomized, double blind, placebo controlled crossover study. A complete cardiac exam will be conducted by the pediatric cardiology team at the Robert Wood Johnson Medical School. All participants will remain on their existing, pre-study medication throughout all phases of the study.

Once admitted to the study, a baseline period will begin. During the baseline period, cognitive and adaptive information will be collected. The participant will then be randomly assigned to propranolol (Phase A) or placebo (Phase B). The titration schedule will be flexible and the dose can be held steady for an extended period. Dose reduction to manage side effects are allowed at any time. Each week the family will complete behavioral forms online and meet with the study psychiatrist via telemedicine. Following the initial Phase (A or B), participants will undergo a washout period (whether propranolol or placebo). Then, they will crossover to the other Phase (A or B). Upon completion of the crossover phase, the study blind will be broken. The participants then had the option of enrolling in an open label study.

Conditions: Autism Spectrum Disorder, Developmental Disability, Aggression, Self-Injurious Behavior, Challenging Behavior
Being tested: Propranolol
Keywords: Propranolol, Beta Blocker, Psychopharmacology, Inderal
Medical subject headings: Autism Spectrum Disorder, Developmental Disabilities, Aggression, Self-Injurious Behavior

What participants receive

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

PropranololDrug
Also called Inderal
Propranolol is a beta-blocker used to treat high blood pressure, irregular heartbeats, and tremors. It is used after a heart attack and to prevent migraine headaches and chest pain. It is also used off-label for anxiety and PTSD.

Study groups in NCT04047355
Study group	Role	What they receive
Group A: Propranolol first	Experimental	Participants randomly assigned to this group will receive Propranolol first. After the washout period, they will receive Placebo. Propranolol will be given in liquid or pill form. Receives: Drug: Propranolol
Group B: Placebo first	Placebo comparator	Participants randomly assigned to this group will receive Placebo first. After the washout period, they will receive Propranolol. Placebo will look identical to the study drug Propranolol. Receives: Drug: Propranolol

What is being measured

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

Aberrant Behavior Checklist--Community (ABC-C) Irritability Subscale Scores
The Aberrant Behavior Checklist--Community (ABC-C) is a behavior checklist that measures drug and other treatment effects in people with intellectual and developmental disabilities. It is made up of five subscales, including Irritability, Lethargy, Inappropriate Speech, Hyperactivity, and Stereotypy based on 58 items that describe various behavioral problems. Each item is scored on a Likert scale: 1 = not at all a problem, to 3 = problem is severe in degree. The Irritability Subscale served as the primary dependent measure. The minimum score on the Irritability Subscale is 0 and the maximum score is 45. Lower scores represent better outcome.
Measured: Titration schedule varied based on individual response; it was not predetermined. On average, Placebo was 8 wks and Propranolol was 11 wks, including titration. The last Baseline score and the last scores from Placebo and Propranolol phases were analyzed.

Secondary outcomes (1)

Clinical Global Impression Improvement (CGI-I) Scale
The Clinical Global Impression Improvement (CGI-I) scale is used by the study psychiatrist to judge the overall clinical condition relative to baseline using the same scale as the CGI-S. The study psychiatrist will rate the improvement from baseline. The CGI consists of a 7-point subjective scale assessing symptom. Lower scores represent better outcomes. Scores of 1, 2, and 3 represent normal, some presence of symptoms, and mild behavior, respectively. A score of 4 represents moderate behavior. Scores of 5, 6, and 7 represent marked, severe, and among the most severe behavior, respectively.
Measured: Titration schedule varied based on individual response; it was not predetermined. On average, Placebo was 8 wks and Propranolol was 11 wks, including titration. The last Baseline score and the last scores from Placebo and Propranolol phases were analyzed.

Timeline

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

11 Feb 202130 Sep 2023

First posted6 Aug 2019
Study start11 Feb 2021
Primary completion30 Sep 2023
Study completion30 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Autism Spectrum DisorderStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04047355
Sponsor's protocol ID: Pro20170001942
Other IDs: CAUT17 APL025
Status last verified: May 2025
First submitted: 12 Jul 2019
Last updated: 4 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

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

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

Questions to ask the study team

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

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot/Feasibility Study of the Use of High Dose Propranolol to Treat Severe and Chronic Challenging Behaviors in Adolescents and Adults With Autism Spectrum Disorders
ClinicalTrials.gov ID: NCT04047355
Acronym / sponsor ID: Pro20170001942
Conditions: Autism Spectrum Disorder, Developmental Disability, Aggression, Self-Injurious Behavior, Challenging Behavior
Keywords: Propranolol, Beta Blocker, Psychopharmacology, Inderal
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Rutgers, The State University of New JerseyUniversity, hospital or other
Collaborators: New Jersey Governor's Council for Medical Research and Treatment of Autism, New York State Institute for Basic Research
Study start: 11 Feb 2021 (actual)
Primary completion: 30 Sep 2023 (actual)
Study completion: 30 Sep 2023 (actual)
First posted: 6 Aug 2019 (actual)
Results: Posted 4 Jun 2025

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group A: Propranolol first	Experimental	Drug: PropranololParticipants randomly assigned to this group will receive Propranolol first. After the washout period, they will receive Placebo. Propranolol will be given in liquid or pill form.
Group B: Placebo first	Placebo comparator	Drug: PropranololParticipants randomly assigned to this group will receive Placebo first. After the washout period, they will receive Propranolol. Placebo will look identical to the study drug Propranolol.

Who may qualify

Ages: 12 to 30 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (11 listed)

Males and females between the ages of 12-30 years and is a resident in the state of New Jersey.
Diagnosis of autism conducted by a clinician with confirmation using the Autism Diagnostic Observation Schedule (ADOS) or the Social Communication Questionnaire (SCQ).
At least one of the following challenging behaviors.
Pharmacologic treatment with at least two psychotropic including one antipsychotic medication has yielded inadequate outcome (partial improvement on one or more medications is acceptable for the study).
Clinical Global Impression Severity scale score of 6 or 7.

Key exclusion criteria (8 listed)

Asthma or any history of asthma or any disorder involving bronchoconstriction.
Cardiac Diseases in which the use of propranolol at high doses would be contraindicated.
Uncontrolled Seizure disorder (participant had a seizure within the past year and/or changes in seizure medication in the previous six months).
Diabetes or a history of ketoacidosis.
Any other medical disorder or medication which would contraindicate the use of propranolol.

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
PropranololAlso: InderalPropranolol is a beta-blocker used to treat high blood pressure, irregular heartbeats, and tremors. It is used after a heart attack and to prevent migraine headaches and chest pain. It is also used off-label for anxiety and PTSD.	Drug	Group A: Propranolol first, Group B: Placebo first

Primary outcome

Aberrant Behavior Checklist--Community (ABC-C) Irritability Subscale Scores
Time frame: Titration schedule varied based on individual response; it was not predetermined. On average, Placebo was 8 wks and Propranolol was 11 wks, including titration. The last Baseline score and the last scores from Placebo and Propranolol phases were analyzed.
The Aberrant Behavior Checklist--Community (ABC-C) is a behavior checklist that measures drug and other treatment effects in people with intellectual and developmental disabilities. It is made up of five subscales, including Irritability, Lethargy, Inappropriate Speech, Hyperactivity, and Stereotypy based on 58 items that describe various behavioral problems. Each item is scored on a Likert scale: 1 = not at all a problem, to 3 = problem is severe in degree. The Irritability Subscale served as the primary dependent measure. The minimum score on the Irritability Subscale is 0 and the maximum score is 45. Lower scores represent better outcome.

1 secondary outcome

Clinical Global Impression Improvement (CGI-I) Scale
Time frame: Titration schedule varied based on individual response; it was not predetermined. On average, Placebo was 8 wks and Propranolol was 11 wks, including titration. The last Baseline score and the last scores from Placebo and Propranolol phases were analyzed.

Results and safety

Results posted to the registry on 4 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: Propranolol First, Then Placebo Second	3	3
Group B: Placebo First, Then Propranolol Second	3	3

Primary outcome: Aberrant Behavior Checklist--Community (ABC-C) Irritability Subscale Scores

Time frame: Titration schedule varied based on individual response; it was not predetermined. On average, Placebo was 8 wks and Propranolol was 11 wks, including titration. The last Baseline score and the last scores from Placebo and Propranolol phases were analyzed.. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Propranolol Phase n = 6	Placebo Phase n = 6
Value	14.0 (6.25 to 16.50)	18.50 (12.25 to 27.25)

Propranolol Phase vs Placebo Phase: Median Difference (Final Values): 3.00, p = 0.12, Wilcoxon (Mann-Whitney)
Propranolol Phase vs Placebo Phase: Effect size (r): -0.64
Propranolol Phase vs Placebo Phase: Post-hoc power analysis: 0.39

Population analysed: Participants served as their own controls. Each participant received both Propranolol and Placebo. The treatment order was randomized.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Weekly over the entire double-blind portion of the study. Exact duration varied per participant due to individualized titration periods (approximately 5-7 months based on individual titration schedule). The open label phase was two months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Propranolol	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Placebo	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Open Label	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Barbie Zimmerman-Bier, M.D. principal investigator

Rutgers, The State University of New Jersey

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Propranolol in people with Autism Spectrum Disorder and Developmental Disability, run by Rutgers, The State University of New Jersey 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 11 inclusion and 8 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 4 Jun 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aberrant Behavior Checklist--Community (ABC-C) Irritability Subscale Scores (time frame: Titration schedule varied based on individual response; it was not predetermined. On average, Placebo was 8 wks and Propranolol was 11 wks, including titration. The last Baseline score and the last scores from Placebo and Propranolol phases were analyzed.). 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 NCT04047355.

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 4 Jun 2025.