Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period
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|ClinicalTrials.gov Identifier: NCT02611687|
Recruitment Status : Active, not recruiting
First Posted : November 23, 2015
Last Update Posted : January 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|Narcolepsy With Cataplexy Narcolepsy Without Cataplexy||Drug: pitolisant Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Cataplexy, Followed by a Prolonged Open-label Period|
|Actual Study Start Date :||June 6, 2016|
|Actual Primary Completion Date :||April 3, 2021|
|Estimated Study Completion Date :||September 2022|
tablet, oral, once a day.
Other Name: BF2.649
Placebo Comparator: placebo
tablet, oral, once a day.
- To evaluate the efficacy of pitolisant in reducing residual Excessive Daytime Sleepiness (EDS). [ Time Frame: 8 weeks ]Changes in EDS measured by the Ullanlinna Narcolepsy Scale Score (UNS).
- 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 .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611687
|Terveystalo Helsinki Uniklinikka|
|Hôpital Gui de Chauliac|
|Hôpital Robert Debré|
|Università di Bologna|
|Polikliniek Heemstede Neurologist-Somnologist|
|Scientific-Research Medical Complex "Your Health"|
|Kazan, Russian Federation|
|I.M. Sechenov First Moscow State Medical University|
|Moscow, Russian Federation|
|V.M. Behterev National Medical Research Psychiatry and Neurology Center|
|Saint Petersburg, Russian Federation|
|Samara Regional Clinical Hospital|
|Samara, Russian Federation|
|N.I. Balaban Crimea Repiblic Clinical Psychiatric Hospital No. 1|
|Simferopol, Russian Federation|
|Study Chair:||Giuseppe Plazzi, MD||Dipartimento di Scienze Biomediche e Neuromotorie Alma Mater Studiorum - Università di Bologna|