At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 237 enrolled
Drug / intervention
Pimavanserin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder
In Brief
A Phase 3 clinical trial evaluating Pimavanserin and Placebo for Irritability Associated With Autism Spectrum Disorder. Completed, enrolled 237 participants across 57 sites in 8 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, France, Hungary, Italy, Poland, Serbia, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
Enrollment StartAug 2022
First PostedAug 2022
Primary CompletionSep 2024
TodayJul 2026
First PostedAug 31, 2022
Enrollment StartAug 9, 2022
Primary CompletionSep 27, 2024
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 3.8 years ago
Interventions
Pimavanserindrug
Pimavanserin
Placebodrug
Pimavanserin matching placebo