Trials / Active Not Recruiting
Active Not RecruitingNCT05953389
Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents
An Exploratory, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect and Safety of Pitolisant in Children and Adolescents With Autism Spectrum Disorders
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- Sponsor
- Bioprojet · Academic / Other
- Sex
- Male
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pitolisant | histamine H3 receptor antagonist/inverse agonist |
| DRUG | Placebo | Matching placebo of pitolisant tablets |
Timeline
- Start date
- 2023-12-20
- Primary completion
- 2025-10-01
- Completion
- 2025-11-01
- First posted
- 2023-07-20
- Last updated
- 2025-10-02
Locations
15 sites across 4 countries: France, Italy, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT05953389. Inclusion in this directory is not an endorsement.