Trial · NCT05953389
Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents
NCT05953389, Phase 2, Active not recruiting, Bioprojet
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents. Trials, record NCT05953389. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05953389
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents
- NCT number
- NCT05953389
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 62 participants, estimated
- Lead sponsor
- Bioprojet
- Conditions
- Autism Spectrum Disorder
- Interventions
- Pitolisant, Placebo
- First posted
- 2023-07-20
- Last updated
- 2025-10-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Social Responsiveness Scale Second Edition (SRS-2) total score | 12 weeks | 65-item informant-based rating scale designed specifically for use in Autism Spectrum Disorders to quantitatively measure an individual's ability to engage in emotionally appropriate reciprocal social behavior with higher scores indicating greater impairment. |
| Secondary | Vineland Adaptive Behavior Scale III (VABS III) total score | 12 weeks | Instrument that measures socialization, communication, daily living skills, motor skills and maladaptive behavior of individuals with intellectual disabilities; |
| Secondary | Incidence of Treatment-Emergent adverse events (AEs) as assessed by AEs collection | 12 weeks | Safety assessment of pitolisant based on adverse events (AEs) reporting during the treatment pe |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05953389
GET https://conductscience.org/api/trials/v1/NCT05953389/registered