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

NCT02611687 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-06-26

Study results available
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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

DRUG

pitolisant

Tablet

DRUG

Placebo

Tablet

Sponsors & Collaborators

Principal Investigators

  • Giuseppe Plazzi, MD · Dipartimento di Scienze Biomediche e Neuromotorie Alma Mater Studiorum - Università di Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-06
Primary Completion
2021-04-03
Completion
2025-06-05

Countries

  • Finland
  • France
  • Italy
  • Netherlands
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02611687 on ClinicalTrials.gov