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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Propranolol
Placebo
Magnetic Resonance Imaging (MRI)
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism, ASD

Eligibility Criteria

7 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Taking Alpha 2 agonists
  • Non-autism learning disorder
  • Other major psychiatric disorders
  • Other neurological disorders
  • Major head trauma
  • Reaction to adhesives
  • 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)

Sites / Locations

  • Thompson Center for Autism & Neurodevelopmental Disorders

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Propanolol and MRI

Placebo and MRI

Arm Description

Participants 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.

Participants will receive placebo via oral capsule, crushed tablet, or liquid daily. Those aged 15-24 will have an MRI before starting drug.

Outcomes

Primary Outcome Measures

Change in General Social Outcomes Measure (GSOM) Assessment

Secondary Outcome Measures

Change in Social Responsiveness Scale (SRS-2)
Change in score on Anagrams test
For those aged 15-24 only
Change in Semantic fluency test results
For those aged 15-24 only
Change Clinical Global Impression surveys
Change in Autism Impact Measure (AIM)
Change in Clinical Evaluation of Language Fundamentals (CELF-5) assessment
Change in Vineland Adaptive Behavior Scales (VABS-2) assessment
Change in score on Aberrant Behavior Checklist (ABC)
Change in gastrointestinal symptomology
Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PDQ-child) and Rome IV Diagnostic Questionnaire (R4DQA) for adults

Full Information

First Posted
August 15, 2016
Last Updated
October 7, 2020
Sponsor
University of Missouri-Columbia
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT02871349
Brief Title
Trial of Propranolol in Children and Youth With Autism Spectrum Disorder and Predictors of Response
Official Title
Trial of Propranolol in Children and Youth With Autism Spectrum Disorder and Predictors of Response
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2020 (Actual)
Study Completion Date
August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
Collaborators
United States Department of Defense

4. Oversight

5. Study Description

Brief 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 treatment options for language impairments and social difficulties often experienced by people with autism.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism, ASD

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propanolol and MRI
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Placebo and MRI
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo via oral capsule, crushed tablet, or liquid daily. Those aged 15-24 will have an MRI before starting drug.
Intervention Type
Drug
Intervention Name(s)
Propranolol
Other Intervention Name(s)
Inderal, Hemangeol, Innopran
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Intervention Description
An MRI will be performed on participants aged 15-24 years.
Primary Outcome Measure Information:
Title
Change in General Social Outcomes Measure (GSOM) Assessment
Time Frame
Day 1, 6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change in Social Responsiveness Scale (SRS-2)
Time Frame
Day 1, 6 weeks, 12 weeks
Title
Change in score on Anagrams test
Description
For those aged 15-24 only
Time Frame
Day 1, 6 weeks, 12 weeks
Title
Change in Semantic fluency test results
Description
For those aged 15-24 only
Time Frame
Day 1, 6 weeks, 12 weeks
Title
Change Clinical Global Impression surveys
Time Frame
Day 1, 6 weeks, 12 weeks
Title
Change in Autism Impact Measure (AIM)
Time Frame
Day 1, 6 weeks, 12 weeks
Title
Change in Clinical Evaluation of Language Fundamentals (CELF-5) assessment
Time Frame
Day 1, 6 weeks, 12 weeks
Title
Change in Vineland Adaptive Behavior Scales (VABS-2) assessment
Time Frame
Day 1, 6 weeks, 12 weeks
Title
Change in score on Aberrant Behavior Checklist (ABC)
Time Frame
Day 1, 6 weeks, 12 weeks
Title
Change in gastrointestinal symptomology
Description
Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PDQ-child) and Rome IV Diagnostic Questionnaire (R4DQA) for adults
Time Frame
Day 1, 1 week, 2 weeks, 6 weeks, 12 weeks
Other Pre-specified Outcome Measures:
Title
Change in Companion Animal Bonding Scale
Time Frame
Day 1, 6 weeks, 12 weeks
Title
Change in Sympathetic Tone & Anxiety Measurements
Description
Pupillary light reflex, heart rate, heart rate variability, skin conductance, and blood pressure
Time Frame
Day 1, 12 weeks
Title
Changes in salivary cortisol
Time Frame
Day 1, 6 weeks, 12 weeks
Title
Changes in Sensory Over-Responsivity questionnaire
Time Frame
Day 1, 6 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Taking Alpha 2 agonists Non-autism learning disorder Other major psychiatric disorders Other neurological disorders Major head trauma Reaction to adhesives 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Q Beversdorf, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thompson Center for Autism & Neurodevelopmental Disorders
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States

12. IPD Sharing Statement

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

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