Clinical Trial: Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Double Blind, Multicentre, Randomized, Placebo-controlled Trial to Evaluate Safety and Efficacy of Pitolisant in Children From 6 to Less Than 18 Years With Narcolepsy With/Without

  • To evaluate the efficacy of pitolisant in reducing residual Excessive Daytime Sleepiness (EDS) [ Time Frame: 8 weeks ]
    Changes in EDS measured by the Paediatric Daytime Sleepiness Scale (PDSS).
  • To evaluate the efficacy of pitolisant in reducing the number of cataplectic episodes (for patients with cataplexy) [ Time Frame: 8 weeks ]
    Changes in the average number of cataplexy episodes per weeks (recorded in sleep diary).
  • To determine safety in children and adolescents - Safety assessment will be done on monitoring of adverse events, physical examination, vital signs, ECG (QTc) and Blood Laboratory tests modifications and the mood appraisal [ Time Frame: 8 weeks ]
    Safety assessment will be done on monitoring of adverse events (Incidence of Treatment-Emergent Adverse Events), physical examination, vital signs (blood pressure and heart rate), ECG (QTc) and Blood Laboratory tests modifications (Haematology and Biochemistry) and the mood appraisal (Childhood Depression Inventory [CDI] and Columbia-Suicide Severity Rating Scale [C-SSRS]) throughout the study .


    • Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Bioprojet

    Dates:
    Date Received: November 16, 2015
    Date Started: April 2016
    Date Completion: December 2018
    Last Updated: April 13, 2017
    Last Verified: April 2017