NCT02611687

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

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 Cataplexy, Followed by a Prolonged Open-label Period

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Bioprojet · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this multicenter double blind study is to assess efficacy and safety of Pitolisant versus placebo in paediatric Narcoleptic patients with or without cataplexy.

Conditions

• Narcolepsy With Cataplexy
• Narcolepsy Without Cataplexy

Interventions

Type	Name	Description
DRUG	pitolisant	Tablet
DRUG	Placebo	Tablet

Timeline

• Start date: 2016-06-06
• Primary completion: 2021-04-03
• Completion: 2025-06-05
• First posted: 2015-11-23
• Last updated: 2025-06-26
• Results posted: 2024-09-19

Locations

11 sites across 5 countries: Finland, France, Italy, Netherlands, Russia