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Pitolisant tablet

A Study of Pitolisant in Patients With Prader-Willi Syndrome

Ensayo de Harmony Biosciences Holdings, Inc. en Sindrome de Prader-Willi.

Más ensayos de: Síndrome de Prader-Willi.

Fase

Fase 3

Estado

Reclutando pacientes

Participantes

134

previstos

Centros

57

Fin del objetivo primario

abr 2027

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en may 2024.

Qué mide

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)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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

Más ensayos de HRMY

Todos los de HRMY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06366464), actualizada en ago 2026.