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Last Updated: September 26, 2022

CLINICAL TRIALS PROFILE FOR ADZENYS ER


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All Clinical Trials for ADZENYS ER

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03242772 ↗ Impact of Combined Medication and Behavioral Treatment for ASD & ADHD Terminated Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 2018-12-14 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 coached in even though they will not receive parent coaching. Participants will be given the option to pursue ADHD medication outside of the research study after week 11 assessments.
NCT03242772 ↗ Impact of Combined Medication and Behavioral Treatment for ASD & ADHD Terminated Duke University Phase 2 2018-12-14 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 coached in even though they will not receive parent coaching. Participants will be given the option to pursue ADHD medication outside of the research study after week 11 assessments.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ADZENYS ER

Condition Name

Condition Name for ADZENYS ER
Intervention Trials
Autism Spectrum Disorder 1
Attention Deficit Hyperactivity Disorder 1
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Condition MeSH

Condition MeSH for ADZENYS ER
Intervention Trials
Disease 1
Autism Spectrum Disorder 1
Attention Deficit Disorder with Hyperactivity 1
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Clinical Trial Locations for ADZENYS ER

Trials by Country

Trials by Country for ADZENYS ER
Location Trials
United States 1
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Trials by US State

Trials by US State for ADZENYS ER
Location Trials
North Carolina 1
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Clinical Trial Progress for ADZENYS ER

Clinical Trial Phase

Clinical Trial Phase for ADZENYS ER
Clinical Trial Phase Trials
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for ADZENYS ER
Clinical Trial Phase Trials
Terminated 1
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Clinical Trial Sponsors for ADZENYS ER

Sponsor Name

Sponsor Name for ADZENYS ER
Sponsor Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 1
Duke University 1
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Sponsor Type

Sponsor Type for ADZENYS ER
Sponsor Trials
NIH 1
Other 1
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