Overview

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

Status:
Active, not recruiting
Trial end date:
2020-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bioprojet
Criteria
Inclusion Criteria:

- Male and female children from 6 to less than 18 years of age suffering from narcolepsy
with or without cataplexy - ICSD-3 criteria (narcolepsy type 1 and 2).

- PDSS

- Patients should be free of non-authorized medication, in particular psychostimulant
treatments as from the screening visit onwards.

- Parents - and patients old enough to understand who have expressed a willingness to
participate in the study, who have signed and dated the informed consent form prior to
beginning protocol required procedures.

- In the opinion of the investigator, the patient must have adequate support to comply
with the entire study requirements as described in the protocol (e.g., transportation
to and from trial site, self rating scales and diaries completion, drug compliance,
scheduled visits, tests).

Exclusion Criteria:

- Any other conditions that can be considered the primary causes of EDS.

- Cataplectic patients treated by anticataplectics which are not under a stable
treatment at the time of inclusion.

- Patients treated for cataplexy or any other pathology, by tricyclic antidepressants.

- Any significant abnormality of the electrocardiogram and particularly Fridericia's QTc
interval.

- Patients with significant abnormality or clinical laboratory results.

- Psychiatric and neurological disorders in the investigator's opinion, would preclude
the patient's participation and completion of this trial or comprise reliable
representation of subjective symptoms.

- Active clinically significant illness, including unstable cardiovascular, endocrine,
neoplastic, gastrointestinal, haematological, hepatic, immunologic, metabolic,
neurological (other than narcolepsy/cataplexy), pulmonary, and/or renal disease which
could interfere with the study conduct or counter-indicate the study treatments or
place the patient at risk during the trial or compromise the study objectives.