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

Autism Spectrum Disorder Clinical Trial

Official title:
An Exploratory, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect and Safety of Pitolisant in Children and Adolescents With Autism Spectrum Disorders

Clinical Trial 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.

Clinical Trial Description

First clinical study to assess the effect of BF2.649 in male children and adolescent with a diagnosis of Autism spectrum disorders according to DSM-5 criteria and confirmed by the Autism Diagnostic Observation Schedule (ADOS-2) or Autism Diagnostic Interview-Revised (ADI-R) over a 12-weeks period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05953389
Study type Interventional
Source Bioprojet
Contact Stéphanie Renaux
Phone +33147036633
Email s.renaux@bioprojet.com
Status Not yet recruiting
Phase Phase 2
Start date October 2023
Completion date January 2025
View Details
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