A Study of Pitolisant in Patients With Prader-Willi Syndrome
Prader-Willi SyndromeThis 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
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
6 and up
Critères de participation
Inclusion Criteria:
* Genetically confirmed diagnosis of PWS
* Excessive daytime sleepiness
* Has a consistent parent/caregiver (preferably the same person throughout the study) who is willing and able to complete the required study assessments.
* In the opinion of the Investigator, the patient/parent(s)/caregiver(s)/legal guardian(s) are capable of understanding and complying with the requirements of the protocol and administration of oral study drug.
Exclusion Criteria:
* Has a diagnosis of sleep apnea (OSA, CSA) that is not adequately controlled
* Has a diagnosis of hypersomnia due to another sleep/medical disorder
* Participation in an interventional research study involving another investigational medication, device, or behavioral treatment within 30 days or 5 half-lives (whichever is longer) of the investigational medication prior to Screening
Lieu de l'étude
Jodha Tishon Inc.
Jodha Tishon Inc.Toronto, Ontario
Canada
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AMNDX Inc.
AMNDX Inc.Thornhill, Ontario
Canada
Contactez l'équipe d'étude
- Étude parrainée par
- Harmony Biosciences Management, Inc.
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT06366464