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NCT03242772 · ClinicalTrials.gov registry record · Phase 2
Impact of Combined Medication and Behavioral Treatment for ASD & ADHD
A Phase 2 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT03242772 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 18 participants.
The verdict
NCT03242772, a Phase 2 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
Children with comorbid autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) have significantly worse outcomes than those with either ASD alone or ADHD alone. Effective early treatments that account for ADHD symptoms have not been developed for young children with ASD+ADHD. The overarching goals of this randomized, placebo-controlled, phase 2, pilot study are to (1) evaluate a novel early intervention that pharmacologically addresses ADHD symptoms while providing an ASD-targeted behavioral intervention, and (2) identify changes in behavioral and neurophysiological activity that may underlie improved outcomes in children with comorbid ASD and ADHD ages 3-10 years. The primary aim of this study is to evaluate whether a stimulant treatment augments efficacy of an ASD specific form of parent child therapy based on the Early Start Denver Model called ESDM influenced Parent Coaching. Secondary aims are to determine the efficacy of combined intervention in improving ADHD symptoms and the efficacy, safety, and tolerability of Adzenys-XR-ODT in young children with ASD+ADHD. The study will also examine correlations between behavioral changes and state-of-the-art eye-gaze tracking (EGT) and electroencephalographic (EEG) biomarkers to elucidate key ways in which ADHD impacts attentional and neural functioning in ASD+ADHD, and to potentially identify new targets for intervention in children with ASD+ADHD. The study is about 8 months long and will involve screening, baseline assessment followed by 10- 11 weeks of study drug treatment (active or placebo) and 8 sessions of ESDM informed parent coaching beginning after 2 weeks of study drug treatment, primary endpoint assessments at \~11 weeks, AE follow-up by phone at \~week 13 and remote FU 24 weeks after baseline. Eligible participants will be randomly assigned to the active medication or placebo, Between weeks 11 to 24, it is expected that the parent will use the behavioral strategies they were coach
Interventions
- DRUG Placebo Oral Tablet
- DRUG Amphetamine
- BEHAVIORAL ESDM informed parent coaching
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-12-14 |
| Est. Completion | 2021-04-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03242772
The ClinicalTrials.gov registry entry for NCT03242772 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo Oral Tablet is the first listed.
NCT03242772 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03242772 about?
NCT03242772 is a clinical study titled "Impact of Combined Medication and Behavioral Treatment for ASD & ADHD". Children with comorbid autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) have significantly worse outcomes than those with either ASD alone or ADHD alone. Effective early treatments that account for ADHD symptoms have not been developed for young children with ASD+AD...
What is the current status of trial NCT03242772?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2018-12-14. Estimated completion is 2021-04-19.
What interventions are being tested in trial NCT03242772?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Amphetamine (DRUG), ESDM informed parent coaching (BEHAVIORAL).
Who is sponsoring clinical trial NCT03242772?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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