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

Excessive Daytime Sleepiness Clinical Trial

Official title:

A Randomized, Double Blind Study Comparing Pitolisant (BF2.649) to Placebo in Two Parallel Groups on the Weekly Frequency of Cataplexy Attacks and Excessive Daytime Sleepiness in Narcoleptic Patients With Cataplexy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800045
• Other study ID #: P11-05 / Pitolisant
• Secondary ID: 2012-003076-39
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2013
• Last updated: August 30, 2016
• Start date: April 2013
• Est. completion date: January 2015

Study information

• Verified date: July 2015
• Source: Bioprojet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyMacedonia: Ministry of HealthUkraine: Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal DevicesRussia: Ministry of Health of the Russian FederationTurkey: Ministry of HealthPoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

The treatment period (7 weeks double blind) will aim at demonstrating the efficacy of Pitolisant on the number of cataplexy attacks and the Excessive Daytime Sleepiness by verifying whether the results of Pitolisant are superior to those of placebo.

The safety will also be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataplexy
• Excessive Daytime Sleepiness
• Narcolepsy
• Narcolepsy With Cataplexy

Intervention

Drug:
• Pitolisant
1 capsule in the morning before breakfast
• Placebo
1 capsule in the morning before breakfast

Locations

Country	Name	City	State
Hungary	State Health Center	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Bioprojet

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of anticataplectic efficacy	Measure of anticataplectic efficacy assessed by the change in the average number of cataplexy attacks per week.	At week 7	No
Secondary	Excessive Daytime Sleepiness assessment	Excessive Daytime Sleepiness assessment by evaluation of ESS score, and other questionnaires.	At week 7	No
Secondary	Safety assessment	Safety assessment thanks to AE recording, vitals signs assessment, ECG...	11 weeks	Yes