At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 110 enrolled
Drug / intervention
pitolisant +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating pitolisant and Placebo for Narcolepsy With Cataplexy and Narcolepsy Without Cataplexy. Completed, enrolled 110 participants across 11 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFinland, France, Italy, Netherlands, Russia
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2015
Enrollment StartJun 2016
Primary CompletionApr 2021
Study CompletionJun 2025
TodayJul 2026
First PostedNov 23, 2015
Enrollment StartJun 6, 2016
Primary CompletionApr 3, 2021
Study CompletionJun 5, 2025
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 10.6 years ago
Interventions
pitolisantdrug
Tablet
Placebodrug
Tablet