Share

Research Studying Pimavanserin in Irritability Associated with Pediatric Autism Spectrum Disorder

May 13, 2022 - November 23, 2023

This pediatric autism clinical research study is currently testing the drug, pimavanserin, to see if it is safe and effective in treating irritability and other behaviors in children and adolescents with autism spectrum disorder (ASD). Study participation will last for up to 14 weeks, with a 6-week treatment period. Children who enroll in this study will receive either the study drug or placebo. A placebo looks like the study drug but has no impact on the person taking it. There will be no cost for the study drug or any study-related procedures. You may be compensated for your time and travel. If your child completes the 6-week treatment period, they may be able to enroll in a 52-week, open-label extension study if they qualify. During this open-label study, there is no placebo. Children who enroll will receive the study drug, pimavanserin.

What are the goals of the study?

The overall goal of this study is to evaluate whether an investigational drug might help relieve irritable behaviors associated with Pediatric Autism Spectrum Disorder that make social interactions and everyday functioning challenging.

What will happen during the visit or online?

Study participation will last for up to 14 weeks, with a 6-week treatment period. Children who enroll in this study will receive either the study drug or placebo. A placebo looks like the study drug but has no impact on the person taking it. There will be no cost for the study drug or any study-related procedures. You may be compensated for your time and travel.
If your child completes the 6-week treatment period, they may be able to enroll in a 52-week, open-label extension study if they qualify. During this open-label study, there is no placebo. Children who enroll will receive the study drug, pimavanserin.

How will this help families?

The evaluation of this investigational drug may help relieve irritable behaviors associated with Pediatric Autism Spectrum Disorder that make social interactions and everyday functioning challenging.

Eligibility Criteria

Aged 5 through 17 years old
• DSM-V primary diagnosis of ASD
• ≥18 on the Irritability subscale of the ABC
• ≥4 on the CGI-S of irritability score
• No current comorbid psychiatric disorder other than ADHD or anxiety disorder
• Drug-naïve to antipsychotic treatment (approved or off-label), unless:
• Prior antipsychotic treatment <2 weeks or;
• Lack of tolerability to a prior antipsychotic treatment
• Mental age ≥2 years
• 5th to 95th percentile for weight & height-for-age growth charts (NCHS)
• Able to swallow the test placebo capsule without difficulty.
• No current treatments for irritability and if any previous treatment, washed out ≥5 drug half-lives prior to Baseline
• Discontinued from all prohibited concomitant medications
• If behavioral therapy, stable for at least 4w prior to Screening and consistent throughout the study
• Clinically stable for at least 12 weeks prior to Screening
• Fertile female must agree to use to use a highly effective non-hormonal contraception from 28 days before Baseline to 45 days after last dose of study drug

Contact Information

Robert Hofbauer (609) 250-6221

 

Research Study Website
The Penguin Study
Head to Research Study Website

More Research studies from this topic: Diagnosis

Autism Biomarkers Consortium for Clinical Trials
In-person participation required
Compensation Skills in Autism
Online web-based study
Generating Effectiveness Mechanisms in RUBI (GEMs in RUBI)
In-person participation required
Autism-relevant profiles in neurogenetic syndromes
Online web-based study
Multi-Site Validation Study of Eye Tracking-Based Measure of Autism Symptom Severity
In-person participation required
Intranasal Vasopressin Treatment in Children with Autism
In-person participation required
The EMBRACED Study
Online web-based study
LAAMB Study
In-person participation required
Center for Brain Disease Diagnosis at the NRI
In-person participation required Online web-based study
Neural basis of social cognition in youth with ASD and psychosis
In-person participation required
San Diego State University Toddler MRI Project
In-person participation required
Autism Home Videos for Children
Online web-based study
Autism face fMRI
In-person participation required
Cute Aggression in Children with and without Autism Spectrum Disorder
Online web-based study
Autism Intervention Research Network on Behavioral Health
Online web-based study
Simons Searchlight
Online web-based study
LISTEN: Electrophysiological correlates of language processing in minimally verbal children with neurodevelopmental disorders
In-person participation required
The Autism Biomarkers Consortium for Clinical Trials: Confirmation Study
In-person participation required
Predicting and Optimizing Language Outcomes in Minimally Verbal Children with Autism Spectrum Disorder (POLO)
In-person participation required
Adolescent Communication of Emotion Study
In-person participation required
Social Motivation
In-person participation required
Pivotal Response Treatment for Children with Autism Spectrum Disorders
In-person participation required
COBRA (Connectivity in the Brain and Autism)
In-person participation required
Exploring Positive and Negative Dimensions in Autism Spectrum Disorders (EXPAND)
In-person participation required
MARBLES
In-person participation required
CHARGE
In-person participation required
Imaging Cognition and Neurodevelopment (ICAN)
In-person participation required
Infant-Caregiver Synchrony in Autism
In-person participation required
MRI Study for Prediction of ASD
In-person participation required
Walking and Talking in Autism
In-person participation required
RARE-X Data Collection Program
Online web-based study
Next Generation Siblings: How Having a Sibling with ASD Affects One’s Decision to Have Children
Online web-based study
Cognitive Functioning in Children
Online web-based study
Infant Brain Imaging Study for Autism
In-person participation required
The Autism Biomarkers Consortium for Clinical Trials: Confirmation Study
In-person participation required
Pubertal, Psychosocial and Physiological Development in Females with Autism
In-person participation required
Your View
In-person participation required Online web-based study
Investigating Depressive Symptomatology in Adolescents with ASD and ADHD
Online web-based study
Genetics of Autism in Latinx Ancestries
In-person participation required
Caregiver-Endorsed Strategies for the Treatment of Sensory Reactivity Symptoms in Children with Neurodevelopmental Disorders
Online web-based study
Social Computations in Autism with Neuroimaging
In-person participation required
Social Dynamics and Early Visual Experiences
In-person participation required
Validation of Autism Diagnostic Interview-3rd Edition (ADI-3)
In-person participation required
Assessing Motor Control across different Sensory Environments in Individuals with and without Autism Spectrum Disorder
In-person participation required
Characterizing Electroencephalogram (EEG) Index of Plasticity of the Social Brain in Autism Spectrum Disorder
In-person participation required
Social Cognition in Brain and Behavior
Online web-based study In-person participation required
Sensory Reactivity and Regulation Development
In-person participation required
Sensory Over-Responsivity Propranolol Pilot
In-person participation required
TMS in ASD for Sensory Over-Responsiveness
In-person participation required
Neural Mechanisms of Cognitive Inflexibility in Autism Spectrum Disorder
In-person participation required
The neuroanatomical basis for face processing deficits in autism spectrum disorder
In-person participation required
Investigating neurocognitive profiles in parents of children with autism and anorexia
Online web-based study
Cannabidivarin (CBDV) vs. Placebo in Children with Autism Spectrum Disorder (ASD)
In-person participation required
Following Language Growth in Autism at Home (FLASH)
Online web-based study In-person participation required
Perception of Conversations Survey
Online web-based study
WATCH Motor Development Study: Advancing Screening Tools for ASD
In-person participation required
Family-Implemented Treatment for Behavioral Inflexibility (FITBI) Project
Online web-based study
The Investigation of Genetics Exome Research (TIGER-3)
Online web-based study In-person participation required
A Pilot Study of Transcranial Direct Current Stimulation (tDCS) in Children with Autism Spectrum Disorder (ASD)
In-person participation required
A qualitative study to develop global impression items and a goal attainment scaling approach as outcome measures in paediatric autism
Online web-based study
AB-2004 in Treatment of Adolescents With Irritability Associated With Autism Spectrum Disorder
In-person participation required
Assessing Functional Language Development via Telehealth
Online web-based study
SMASS
Online web-based study
Mapping brain function in children with autism spectrum disorder with diffuse optical tomography
In-person participation required
Children Learning Language Collaboration Project
In-person participation required
Eye-tracking In-person Research
In-person participation required