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

> **NCT05953389** · PHASE2 · ACTIVE_NOT_RECRUITING · sponsor: **Bioprojet** · enrollment: 62 (estimated)

## Conditions studied

- Autism Spectrum Disorder

## Interventions

- **DRUG:** Pitolisant
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT05953389
- **Lead sponsor:** Bioprojet
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2023-12-20
- **Primary completion:** 2025-10
- **Final completion:** 2025-11
- **Target enrollment:** 62 (ESTIMATED)
- **Last updated:** 2025-10-02


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05953389

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05953389, "Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT05953389. Licensed CC0.

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