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

NCT05953389 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-10-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pitolisant

histamine H3 receptor antagonist/inverse agonist

DRUG

Placebo

Matching placebo of pitolisant tablets

Sponsors & Collaborators

Principal Investigators

  • Olivier Bonnot, MD, Prof. · Etablissement Public de Santé Barthélemy Durand, Sainte-Geneviève-des-Bois, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2025-10-31
Completion
2025-11-30

Countries

  • France
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05953389 on ClinicalTrials.gov