drugset / Trial / NCT05953389
Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Proof of concept, multicenter, randomized, double-blind, placebo-controlled, parallel-group, study to investigate the effect, safety, tolerability and pharmacokinetics of pitolisant in male children and adolescents with Autism Spectrum Disorders.
Timeline
- Start
- 2023-12-20
- Primary completion
- 2025-10
- Completion
- 2025-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pitolisant | Small molecule | 5 mg | — |
| Subject | Pitolisant | Small molecule | 10 mg | — |
| Subject | Pitolisant | Small molecule | 20 mg | — |
| Subject | Pitolisant | Small molecule | 40 mg | — |