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Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder

NCT05523895 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2025-08-24

Study results available
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Summary

6-week, randomized, double-blind, fixed-dose, placebo-controlled, parallel group study in children and adolescents (aged 5 to17 years) with autism spectrum disorder (ASD) with irritability, agitation, or self-injurious behaviors to study the efficacy and safety of pimavanserin

Conditions

  • Irritability Associated With Autism Spectrum Disorder

Interventions

DRUG

Pimavanserin

Pimavanserin

DRUG

Placebo

Pimavanserin matching placebo

Sponsors & Collaborators

  • ACADIA Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-09
Primary Completion
2024-09-27
Completion
2024-09-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Hungary
  • Italy
  • Poland
  • Serbia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05523895 on ClinicalTrials.gov