protocolSection identificationModule nctId: NCT06366464, orgStudyIdInfo id: HBS-101-CL-312, briefTitle: A Study of Pitolisant in Patients With Prader-Willi Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Harmony Biosciences, LLC, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome.Secondary objectives include assessing the impact of pitolisant on:* Irritable and disruptive behaviors* Hyperphagia* Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech, conditionsModule conditions: Prader-Willi Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 134, type: ESTIMATED, armsInterventionsModule interventions name: Pitolisant tablet, interventions name: Placebo tablet, outcomesModule primaryOutcomes measure: Change in severity of EDS as measured by Patient-Reported Outcomes Measurement Information System Bank v1.0 - Sleep-Related Impairment (PROMIS-SRI) T-score, secondaryOutcomes measure: Change in severity of irritable and disruptive behaviors as measured by the Aberrant Behavior Checklist-Community, Second Edition (ABC-C) Irritability domain, secondaryOutcomes measure: Change in overall severity of EDS as measured by the Caregiver Global Impression of Severity for Excessive Daytime Sleepiness (CaGI-S for EDS), secondaryOutcomes measure: Change in overall severity of EDS as measured by the Clinical Global Impression of Severity for Excessive Daytime Sleepiness (CGI-S for EDS), secondaryOutcomes measure: 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, secondaryOutcomes measure: 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), secondaryOutcomes measure: Change in severity of EDS as measured by the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD [parent/caregiver version]) total score, secondaryOutcomes measure: 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, secondaryOutcomes measure: Percentage of patients reporting TEAEs, eligibilityModule sex: ALL, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Santa Monica Clinical Trials, status: RECRUITING, city: Los Angeles, state: California, zip: 90025, country: United States, contacts name: Daniel Norman, MD, role: CONTACT, contacts name: Pooja Patel, role: CONTACT, phone: (310) 586-0843, email: ppatel@smclinicaltrials.com, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Atlanta Diabetes Associates, status: RECRUITING, city: Atlanta, state: Georgia, zip: 30318, country: United States, contacts name: David G. Robertson, MD, role: CONTACT, contacts name: Amanda Maxson, role: CONTACT, phone: (404) 844-7775, email: amaxson@atlantadiabetes.com, geoPoint lat: 33.749, lon: -84.38798, hasResults: False