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

NCT02871349 | Completed Early Phase 1

• 1 other identifier: 2005213
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism; ASD

Outcome Measures

Primary Outcomes (1)

• Change in General Social Outcomes Measure (GSOM) Assessment

  Day 1, 6 weeks, 12 weeks

Secondary Outcomes (9)

• Change in Social Responsiveness Scale (SRS-2)

  Day 1, 6 weeks, 12 weeks

• Change in score on Anagrams test

  Day 1, 6 weeks, 12 weeks

• Change in Semantic fluency test results

  Day 1, 6 weeks, 12 weeks

• Change Clinical Global Impression surveys

  Day 1, 6 weeks, 12 weeks

• Change in Autism Impact Measure (AIM)

  Day 1, 6 weeks, 12 weeks

Other Outcomes (4)

• Change in Companion Animal Bonding Scale

  Day 1, 6 weeks, 12 weeks

• Change in Sympathetic Tone & Anxiety Measurements

  Day 1, 12 weeks

• Changes in salivary cortisol

  Day 1, 6 weeks, 12 weeks

Study Arms (2)

Propanolol and MRI

EXPERIMENTAL

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.

Drug: Propranolol; Device: Magnetic Resonance Imaging (MRI)

Placebo and MRI

PLACEBO COMPARATOR

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

Drug: Placebo; Device: Magnetic Resonance Imaging (MRI)

Interventions

Propranolol DRUG

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.

Also known as: Inderal, Hemangeol, Innopran

Propanolol and MRI

Placebo DRUG

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.

Placebo and MRI

Magnetic Resonance Imaging (MRI) DEVICE

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

Placebo and MRI; Propanolol and MRI

Eligibility Criteria

• Age: 7 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• United States Department of Defense: collaborator

Study Sites (1)

Thompson Center for Autism & Neurodevelopmental Disorders

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

Propranolol; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• David Q Beversdorf, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Radiology & Thompson Center for Autism & Neurodevelopmental Disorders

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 18, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

US (1)