drugset / Trial / NCT05555615
Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder
NaSingle-groupOpen-labelTreatment
Summary
52-week, open-label extension study of double-blind study ACP-103-069 to determine the long-term safety and tolerability of pimavanserin for the treatment of irritability associated with ASD in children and adolescents (aged 5 to 17 years). ACP-103-069 is a 6-week, randomized, double-blind, fixed-dose, placebo controlled, parallel group study of pimavanserin in children and adolescents with irritability associated with autism spectrum disorder (ASD).
Timeline
- Start
- 2022-11-02
- Primary completion
- 2025-02-14
- Completion
- 2025-02-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pimavanserin | Small molecule | 10 mg | — |
| Subject | Pimavanserin | Small molecule | 20 mg | — |
| Subject | Pimavanserin | Small molecule | 34 mg | — |