Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Double blind, randomized, parallel groups study of Pitolisant versus placebo, in narcoleptic patients experiencing EDS, and cataplexy (minimum of 3 complete or partial cataplexy attacks per week).

The patients will be treated during 7 weeks with Pitolisant or placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bioprojet

Criteria

Main Inclusion Criteria:

• Narcoleptic with cataplexy : at least 3 weekly cataplexy attacks

• ESS > or = 12

• ICF signed and dated

Main Exclusion Criteria:

• Other conditions that could generate EDS

• Psychological and neurological disorders

• Acute or chronic severe disease

• Treatment by prohibited medication