Clinical Trial

Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-07-12; most recent amendment 2025-10-01.
Status change: Recruiting → Active, Not Recruiting 2025-10-01
Status change: Not Yet Recruiting → Recruiting 2024-09-05
Trial Details
NCT Number NCT05953389
Lead Sponsor Bioprojet
Conditions Autism Spectrum Disorder
Enrollment 62 participants
Start Date 2023-12-20
Primary Completion 2025-10 (estimated)
Study Completion 2025-11 (estimated)
Updated on ClinicalTrials.gov 2025-10-02