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NCT05523895 · ClinicalTrials.gov registry record · Phase 2
Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder
A Phase 2 study, sponsored by ACADIA Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 237
- Enrollment target
NCT05523895: Completed Phase 2 study, sponsored by ACADIA Pharmaceuticals.
NCT05523895 is a Phase 2 study that has completed, run by ACADIA Pharmaceuticals. The registered enrollment target is 237 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05523895, a Phase 2 study, has completed, sponsored by ACADIA Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 237 participants
- Enrollment target
Study 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
Primary Outcome
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 pr
Interventions
- DRUG Placebo
- DRUG Pimavanserin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2022-08-09 |
| Est. Completion | 2024-09-27 |
| Phase | Phase 2 |
What the finished NCT05523895 record still lists
NCT05523895 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05523895 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05523895 about?
NCT05523895 is a clinical study titled "Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder". 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
What is the current status of trial NCT05523895?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 237 participants. The study started on 2022-08-09. Estimated completion is 2024-09-27.
What interventions are being tested in trial NCT05523895?
The interventions under investigation include: Placebo (DRUG), Pimavanserin (DRUG).
Who is sponsoring clinical trial NCT05523895?
This trial is sponsored by ACADIA Pharmaceuticals, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05523895's enrollment target sits among peer trials
237 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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