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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

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