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

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ClinicalTrials.gov Identifier: NCT02871349
Recruitment Status : Recruiting
First Posted : August 18, 2016
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
David Beversdorf, University of Missouri-Columbia

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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: Propranolol Drug: Placebo Device: Magnetic Resonance Imaging (MRI) Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Trial of Propranolol in Children and Youth With Autism Spectrum Disorder and Predictors of Response
Study Start Date : August 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Propanolol and MRI
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
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.
Other Names:
  • Inderal
  • Hemangeol
  • Innopran

Device: Magnetic Resonance Imaging (MRI)
An MRI will be performed on participants aged 15-24 years.

Placebo Comparator: Placebo and MRI
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
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.

Device: Magnetic Resonance Imaging (MRI)
An MRI will be performed on participants aged 15-24 years.




Primary Outcome Measures :
  1. Change in General Social Outcomes Measure (GSOM) Assessment [ Time Frame: Day 1, 6 weeks, 12 weeks ]

Secondary Outcome Measures :
  1. Change in Social Responsiveness Scale (SRS-2) [ Time Frame: Day 1, 6 weeks, 12 weeks ]
  2. Change in score on Anagrams test [ Time Frame: Day 1, 6 weeks, 12 weeks ]
    For those aged 15-24 only

  3. Change in Semantic fluency test results [ Time Frame: Day 1, 6 weeks, 12 weeks ]
    For those aged 15-24 only

  4. Change Clinical Global Impression surveys [ Time Frame: Day 1, 6 weeks, 12 weeks ]
  5. Change in Autism Impact Measure (AIM) [ Time Frame: Day 1, 6 weeks, 12 weeks ]
  6. Change in Clinical Evaluation of Language Fundamentals (CELF-5) assessment [ Time Frame: Day 1, 6 weeks, 12 weeks ]
  7. Change in Vineland Adaptive Behavior Scales (VABS-2) assessment [ Time Frame: Day 1, 6 weeks, 12 weeks ]
  8. Change in score on Aberrant Behavior Checklist (ABC) [ Time Frame: Day 1, 6 weeks, 12 weeks ]
  9. Change in gastrointestinal symptomology [ Time Frame: Day 1, 1 week, 2 weeks, 6 weeks, 12 weeks ]
    Rome IV Diagnostic Questionnaire on Pediatric Functional Gastrointestinal Disorders (R4PDQ-child) and Rome IV Diagnostic Questionnaire (R4DQA) for adults


Other Outcome Measures:
  1. Change in Companion Animal Bonding Scale [ Time Frame: Day 1, 6 weeks, 12 weeks ]
  2. Change in Sympathetic Tone & Anxiety Measurements [ Time Frame: Day 1, 12 weeks ]
    Pupillary light reflex, heart rate, heart rate variability, skin conductance, and blood pressure

  3. Changes in salivary cortisol [ Time Frame: Day 1, 6 weeks, 12 weeks ]
  4. Changes in Sensory Over-Responsivity questionnaire [ Time Frame: Day 1, 6 weeks, 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871349


Contacts
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Contact: Bradley J Ferguson, PhD 573-884-9628 fergusonbj@health.missouri.edu
Contact: Samantha G Hunter, MS 573-882-6479 huntersg@health.missouri.edu

Locations
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United States, Missouri
Thompson Center for Autism & Neurodevelopmental Disorders Recruiting
Columbia, Missouri, United States, 65211
Contact: Bradley J Ferguson, PhD    573-884-9628      
Principal Investigator: David Q Beversdorf, MD         
Sponsors and Collaborators
University of Missouri-Columbia
United States Department of Defense
Investigators
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Principal Investigator: David Q Beversdorf, MD University of Missouri-Columbia
  Study Documents (Full-Text)

Documents provided by David Beversdorf, University of Missouri-Columbia:
Study Protocol  [PDF] May 16, 2017


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Responsible Party: David Beversdorf, Professor, Department of Radiology & Thompson Center for Autism & Neurodevelopmental Disorders, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02871349     History of Changes
Other Study ID Numbers: 2005213
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Keywords provided by David Beversdorf, University of Missouri-Columbia:
Autism
ASD
Additional relevant MeSH terms:
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Propranolol
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents