Trial · NCT06366464
A Study of Pitolisant in Patients With Prader-Willi Syndrome
NCT06366464, Phase 3, Recruiting, Harmony Biosciences Management, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Pitolisant in Patients With Prader-Willi Syndrome. Trials, record NCT06366464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06366464
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Pitolisant in Patients With Prader-Willi Syndrome
- NCT number
- NCT06366464
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 134 participants, estimated
- Lead sponsor
- Harmony Biosciences Management, Inc.
- Conditions
- Prader-Willi Syndrome
- Interventions
- Pitolisant tablet, Placebo tablet
- First posted
- 2024-04-16
- Last updated
- 2026-08-25
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in severity of EDS as measured by Patient-Reported Outcomes Measurement Information System Bank v1.0 - Sleep-Related Impairment (PROMIS-SRI) T-score | Baseline and end of the Double Blind Treatment Period (Day 77) | The PROMIS-SRI item bank consists of 13 items with a 5-point rating scale. |
| Secondary | Change in severity of irritable and disruptive behaviors as measured by the Aberrant Behavior Checklist-Community, Second Edition (ABC-C) Irritability domain | Baseline and end of the Double Blind Treatment Period (Day 77) | The ABC-C is a 58-item questionnaire, divided into 5 subscales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactive/Noncompliance, and Inappropriate Speech). |
| Secondary | Change in overall severity of EDS as measured by the Caregiver Global Impression of Severity for Excessive Daytime Sleepiness (CaGI-S for EDS) | Baseline and end of the Double Blind Treatment Period (Day 77) | The CaGI-S for EDS is a 1-item, 5-point rating scale. |
| Secondary | Change in overall severity of EDS as measured by the Clinical Global Impression of Severity for Excessive Daytime Sleepiness (CGI-S for EDS) | Baseline and end of the Double Blind Treatment Period (Day 77) | The CGI-S for EDS is a 1-item, 5-point rating scale. |
| Secondary | Change in overall severity of irritable and disruptive behaviors as measured by the Caregiver Global Impression of Severity (CaGI-S) for Irritable and/or Disruptive Behaviors | Baseline and end of the Double Blind Treatment Period (Day 77) | The CaGI-S for Irritable and/or Disruptive Behaviors is a 1-item, 5-point rating scale. |
| Secondary | Change in severity of hyperphagia as measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), in conjunction with the Food Safe Zone Questionnaire (FSZQ) | Baseline and end of the Double Blind Treatment Period (Day 77) | The HQ-CT is a 9-item measure of food-related preoccupations and problems. The FSZQ is a 20-item measure of environmental controls to manage hyperphagia. |
| Secondary | Change in severity of EDS as measured by the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD [parent/caregiver version]) total score | Baseline and end of the Double Blind Treatment Period (Day 77) | The ESS-CHAD (parent/caregiver version) is an 8-item, 4-point rating scale. |
| Secondary | Change in severity of other behavioral problems as measured by the Aberrant Behavior Checklist-Community, Second Edition (ABC-C) Hyperactivity/Noncompliance, Inappropriate Speech, Social Withdrawal, and Stereotypic Behavior Domains | Baseline and end of the Double Blind Treatment Period (Day 77) | The ABC-C is a 58-item questionnaire, divided into 5 subscales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactive/Noncompliance, and Inappropriate Speech). |
| Secondary | Percentage of patients reporting TEAEs | Baseline up to Day 441 | A treatment-emergent adverse events is any adverse event reported after the first dose of study drug and up to 30 days after final dose of study drug, or any worsening of a pre-existing condition reported after first dose of study drug and up to 30 days after final dose of study drug. |
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/NCT06366464
GET https://conductscience.org/api/trials/v1/NCT06366464/registered