NCT05523895Phase 2, phase 3Completed

Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder

Study sponsor: ACADIA Pharmaceuticals Inc. · ACAD

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2024-09-27Actual

Enrollment · participants237Actual

Source updated2025-08-24Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Irritability Associated With Autism Spectrum Disorder

Treatments or interventions studied

PimavanserinDrugAlso known as Nuplazid
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Change From Baseline at Week 6 in Caregiver-rated Aberrant Behavior Checklist Irritability (ABC-I) Subscale Score; description: The Aberrant Behavior Checklist (ABC) is a caregiver-rated scale comprised of 5 empirically-derived subscales encompassing 58 items that describe various behavior problems. It measures domains of irritability, lethargy/social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech. ABC-I is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A score for each item ranges from 0 indicating "not at all a problem" to 3 indicating "the problem is severe in degree". Subscale scores are calculated by summing the items within that subscale. Higher scores indicate greater impairment.; timeFrame: 6 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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