Cortical Metrics in Intervention Trials With Autism Spectrum Disorders

NCT02212275 | Withdrawn Phase 2

• 2 other identifiers: Pro0006523914-1141
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators overarching aim is to obtain preliminary data to support a larger grant to validate a novel objective, physiologically-based outcome measure for clinical trials in autism spectrum disorders (ASDs) called the cortical metric. Absence of such an outcome measure has greatly hindered the development of treatments for core symptoms of ASD.

Conditions

Autism Spectrum Disorders

Keywords

ASD; autism; typical development; sensory testing; the cortical metric

Outcome Measures

Primary Outcomes (3)

• The difference in the Cortical Metric before and after acute exposure to dextromethorphan (DXM)

  At visit 2 the cortical metric will be measured 20 min prior to a single dose of DXM and 2hrs after the dose of DXM. . This addresses Specific Aim 3 of the trial. There are 3 primary outcomes all involving the cortical metric because the tool will not be useful to detect treatment changes unless all three outcomes demonstrate the desired response. Visit 2 occurs 3 weeks after baseline = time 0

  2 hours after DXM exposure and 20 min before DXM

• Change in the cortical metric

  The difference between the cortical metric measured 20 minutes before DXM treatment at visit 2, which occurs 3 weeks after the baseline = time 0 visit, and the cortical metric measured 3 weeks earlier at the baseline visit = time 0. We presume their will be no major changes in brain functioning over 3 weeks. This addresses Specific Aim 2 of the trial, regarding test retest stability. There are 3 primary outcomes all involving the cortical metric because the tool will not be useful to detect treatment changes unless all three outcomes demonstrate the desired response.

  3 weeks

• The Cortical Metric

  The cortical metric will be measured at the baseline of the study = time 0. We will compare the mean cortical metric and the range of the cortical metric between the ASD and typically developing groups. This addresses Specific Aim 1 of the trial. There are 3 primary outcomes all involving the cortical metric because the tool will not be useful to detect treatment changes unless all three outcomes demonstrate the desired response. The goal of this aim is to replicate the findings of the John Hopkins University group that found differences in the cortical metric between groups of children 8-12 years old with ASD and with typical development.

  Baseline = time 0

Secondary Outcomes (3)

• Aberrant Behavior Checklist (ABC) Total Score

  time 0 (baseline)

• Pervasive Developmental Disorders Behavior Inventory - Screening Version Score (PDDBI-SV) Social Deficit Score

  Baseline = time 0

• Social Responsiveness Scale, Version 2 Total Score (SRS)

  Time 0 = Baseline

Study Arms (2)

Dextromethorphan in ASD

EXPERIMENTAL

8-12 years old: \> 30 boys will be recruited who have a known or suspected diagnosis of ASD confirmed by DSM-5 checklist and the ADOS-2 at screening. They will have the cortical metric measured 20 min prior to receiving DXM and 2 hours after receiving a single age and weight appropriate dose of DXM. The outcome reported is the difference in the cortical metric after the DXM dose and before the DXM dose.

Drug: Dextromethophan

Dextromethorphan in controls

ACTIVE COMPARATOR

30 typically developing boys 8-12 years old who have the cortical metric measured 20 min before receiving a single age and weight appropriate dose of DXM and 2 hours after the single dose of DXM. The reported value will be the difference between the cortical metric 2hrs after the single dose of DXM and the cortical metric 20 minutes prior to the single dose of DXM.

Drug: Dextromethophan

Interventions

Dextromethophan DRUG

A single age and weight appropriate dose of over the counter Delsym Cough Syrup containing only DXM as an active ingredient.

Also known as: Delsym Cough Syrup

Dextromethorphan in ASD; Dextromethorphan in controls

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy Male Boys ages 8-12
• Normal developmental milestones and school performance
• Primary caretaker is able to participate in study appointments as is indicated

You may not qualify if:

• Significant lifetime medical history including non-febrile seizures, neurological problems, psychiatric problems or learning disabilities
• Any sensory impairment (i.e. deafness or blindness)
• st or 2nd degree family members with a history of ASD
• st or 2nd degree family members with ADHD or other developmental problems
• Adverse reaction to dextromethorphan
• Inability to successfully complete and fully understand the reaction time subtest (cortical metrics)
• Group 2 Youth with ASD: 8-12 years old: \> 30 boys will be recruited who have a known or suspected diagnosis of ASD confirmed by DSM-5 checklist and the ADOS-2 at screening.
• Male Boys ages 8-12 with ASD (confirmed by DSM-5 checklist and the ADOS-2)
• IQ's should be within the normal range (≥ 70) (by prior testing or Stanford Binet 5 at screening)
• Primary caretaker is able to participate in study appointments as is clinically indicated
• Ability of child to participate in all aspects of the protocol per investigator clinical judgment
• New educational or behavioral intervention within 4 weeks of baseline
• History of non-febrile seizures, other neurological disorders, psychosis, bipolar disorder, or Tourette Syndrome.
• Any sensory impairment (i.e. deafness or blindness)
• Adverse reaction to dextromethorphan

Sponsors & Collaborators

• Duke University: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (2)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27517, United States

Location

Duke Center for Autism and Brain Development

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Linmarie Sikich, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: August 8, 2014
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 25, 2016

Record last verified: 2016-08

Locations

US (2)