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Autism Spectrum DisorderEarly Phase 1NCT02871349

Trial of Propranolol in Children and Youth With Autism Spectrum Disorder and Predictors of Response

A Early Phase 1 study testing Propranolol and Magnetic Resonance Imaging (MRI) in people with Autism Spectrum Disorder, run by University of Missouri-Columbia 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

The purpose of this study is to find out how the brain of people with autism is affected by Propranolol. Propranolol is not FDA approved for the treatment of autism. Propranolol is FDA approved for the treatment of heart conditions such as blood pressure This research is being done because there are currently no drug… Read more about this study

Who is it for?
Ages 7 to 24 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Propranolol and Magnetic Resonance Imaging (MRI)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
69 participants
Where
1 siteUnited States
Study dates
Aug 2016to Aug 2020
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 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Autism Spectrum Disorder diagnosis
  • intelligence quotient (IQ) >= 85 (if aged 15-24), >= 75 (if aged 7-14)
  • Native English speaker
  • Parent or caregiver must older than 18 years and be a native English speaker

Who cannot join

  • Taking Alpha 2 agonists
  • Non-autism learning disorder
  • Other major psychiatric disorders
  • Other neurological disorders
  • Major head trauma
  • Reaction to adhesives
Show all 15Show fewer
  • Diabetes
  • Reactive airway disease
  • Thyroid disease
  • Bradyarrhythmias
  • Unexplained syncope
  • Pregnancy
  • Possible interacting drugs
  • Underweight (<20kg if aged 7-14 years)
  • Factors affecting ability to have an MRI (if aged 15-24 years)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Thompson Center for Autism & Neurodevelopmental Disorders

    Columbia, Missouri, 65211

Other trials in United States

About this study

The purpose of this study is to find out how the brain of people with autism is affected by Propranolol. Propranolol is not FDA approved for the treatment of autism. Propranolol is FDA approved for the treatment of heart conditions such as blood pressure

This research is being done because there are currently no drug treatment options for language impairments and social difficulties often experienced by people with autism.

Read the detailed description

The specific aim of this study is to examine the effects of serial doses of propranolol on social interaction, and secondarily on language tasks, anxiety, adaptive behaviors, and global function in high functioning adults and adolescents with autism in a double-blinded, placebo-controlled trial. The investigators will also examine whether response to treatment can be predicted based upon markers of autonomic functioning, such as skin conductance, heart rate variability (HRV), and the pupillary light reflex (PLR), and whether anxiety can predict treatment response. The hypothesis is that social functioning and language abilities will benefit from serial doses of propranolol, and that those with the greatest degree of autonomic dysregulation, or the lowest functional connectivity, will demonstrate the greatest benefit from the drug.

Being tested
Propranolol, Placebo, Magnetic Resonance Imaging (MRI)
Keywords
Autism, ASD
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

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

  • PropranololDrug

    Also called Inderal, Hemangeol, Innopran

    Propanolol will be given on a titration schedule in which participants will begin with small doses (single capsules) of the drug and increase to a larger dosage (divided over 3 capsules) over the course of three weeks. Participants aged 15-24 years will undergo an MRI.

  • PlaceboDrug

    Placebo will be given in the form preferred by the participant and on the same schedule as the propanolol regime. Participants aged 15-24 years will undergo an MRI.

  • Magnetic Resonance Imaging (MRI)Device

    An MRI will be performed on participants aged 15-24 years.

Study groups in NCT02871349
Study groupRoleWhat they receive
Propanolol and MRIExperimentalParticipants will receive propranolol via oral capsule, crushed tablet, or liquid daily. The drug dosage will be titrated slowly to ensure the drug is tolerated well. Those aged 15-24 will have an MRI before starting drug.
Receives: Drug: Propranolol; Device: Magnetic Resonance Imaging (MRI)
Placebo and MRIPlacebo comparatorParticipants will receive placebo via oral capsule, crushed tablet, or liquid daily. Those aged 15-24 will have an MRI before starting drug.
Receives: Drug: Placebo; Device: Magnetic Resonance Imaging (MRI)

What is being measured

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

  1. Change in General Social Outcomes Measure (GSOM) Assessment

    Measured: Day 1, 6 weeks, 12 weeks

Secondary outcomes (9)

  1. Change in Social Responsiveness Scale (SRS-2)

    Measured: Day 1, 6 weeks, 12 weeks

  2. Change in score on Anagrams test

    For those aged 15-24 only

    Measured: Day 1, 6 weeks, 12 weeks

  3. Change in Semantic fluency test results

    For those aged 15-24 only

    Measured: Day 1, 6 weeks, 12 weeks

  4. Change Clinical Global Impression surveys

    Measured: Day 1, 6 weeks, 12 weeks

  5. Change in Autism Impact Measure (AIM)

    Measured: Day 1, 6 weeks, 12 weeks

  6. Change in Clinical Evaluation of Language Fundamentals (CELF-5) assessment

    Measured: Day 1, 6 weeks, 12 weeks

  7. Change in Vineland Adaptive Behavior Scales (VABS-2) assessment

    Measured: Day 1, 6 weeks, 12 weeks

  8. Change in score on Aberrant Behavior Checklist (ABC)

    Measured: Day 1, 6 weeks, 12 weeks

  9. Change in gastrointestinal symptomology

    Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PDQ-child) and Rome IV Diagnostic Questionnaire (R4DQA) for adults

    Measured: Day 1, 1 week, 2 weeks, 6 weeks, 12 weeks

Timeline

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

  1. First posted18 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionAug 2020
  4. Study completionAug 2020

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02871349
Sponsor's protocol ID
2005213
Status last verified
Oct 2020
First submitted
15 Aug 2016
Last updated
8 Oct 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Propranolol and Magnetic Resonance Imaging (MRI) in people with Autism Spectrum Disorder, run by University of Missouri-Columbia 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 4 inclusion and 15 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 8 Oct 2020. 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?

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?

Change in General Social Outcomes Measure (GSOM) Assessment (time frame: Day 1, 6 weeks, 12 weeks). 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 NCT02871349.

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 8 Oct 2020.

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