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
Sponsor: Bioprojet
A PHASE3 clinical study on Narcolepsy With Cataplexy and Narcolepsy Without Cataplexy, this trial is completed. The trial is conducted by Bioprojet and has accumulated 16 data snapshots since 2016. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
16 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Jul 2025 — Sep 2025 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
-
Nov 2024 — Jul 2025 [monthly]
Active Not Recruiting PHASE3
-
Oct 2024 — Nov 2024 [monthly]
Active Not Recruiting PHASE3
-
Sep 2024 — Oct 2024 [monthly]
Active Not Recruiting PHASE3
▶ Show 11 earlier versions
-
Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE3
-
Mar 2023 — Jul 2024 [monthly]
Active Not Recruiting PHASE3
-
Feb 2022 — Mar 2023 [monthly]
Active Not Recruiting PHASE3
-
Dec 2021 — Feb 2022 [monthly]
Active Not Recruiting PHASE3
Phase: PHASE2 → PHASE3
-
Jan 2021 — Dec 2021 [monthly]
Active Not Recruiting PHASE2
-
Aug 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
-
Dec 2018 — Aug 2020 [monthly]
Recruiting PHASE2
-
Aug 2018 — Dec 2018 [monthly]
Recruiting PHASE2
-
Jun 2018 — Aug 2018 [monthly]
Recruiting PHASE2
-
Feb 2017 — Jun 2018 [monthly]
Recruiting PHASE2
-
Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE2
First recorded
Jun 2016
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Bioprojet
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Bologna, Italy , Bron, France , Heemstede, Netherlands , Helsinki, Finland , Kazan', Russia , Montpellier, France , Moscow, Russia , Paris, France , Saint Petersburg, Russia , Samara, Russia and 1 more location