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

Primary Purpose

Narcolepsy With Cataplexy, Excessive Daytime Sleepiness

Status

Completed

Phase

Phase 3

Locations

Hungary

Study Type

Interventional

Intervention

Pitolisant

Placebo

About this trial

This is an interventional treatment trial for Narcolepsy With Cataplexy focused on measuring Narcolepsy, Cataplexy, Sleep disorder, Excessive daytime sleepiness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

State Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pitolisant

Placebo

Arm Description

Pitolisant at 5, 10, 20 or 40mg

Capsules of placebo containing lactose

Outcomes

Primary Outcome Measures

Measure of anticataplectic efficacy

Measure of anticataplectic efficacy assessed by the change in the average number of cataplexy attacks per week.

Secondary Outcome Measures

Excessive Daytime Sleepiness assessment

Excessive Daytime Sleepiness assessment by evaluation of ESS score, and other questionnaires.

Safety assessment

Safety assessment thanks to AE recording, vitals signs assessment, ECG...

Full Information

NCT ID

NCT01800045

First Posted

February 13, 2013

Last Updated

August 30, 2016

Sponsor

Bioprojet

1. Study Identification

Unique Protocol Identification Number

NCT01800045

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bioprojet

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Narcolepsy With Cataplexy, Excessive Daytime Sleepiness

Keywords

Narcolepsy, Cataplexy, Sleep disorder, Excessive daytime sleepiness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pitolisant

Arm Type

Experimental

Arm Description

Pitolisant at 5, 10, 20 or 40mg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Capsules of placebo containing lactose

Intervention Type

Drug

Intervention Name(s)

Pitolisant

Other Intervention Name(s)

BF2.649

Intervention Description

1 capsule in the morning before breakfast

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Capsules of placebo containing lactose

Intervention Description

1 capsule in the morning before breakfast

Primary Outcome Measure Information:

Title

Measure of anticataplectic efficacy

Description

Measure of anticataplectic efficacy assessed by the change in the average number of cataplexy attacks per week.

Time Frame

At week 7

Secondary Outcome Measure Information:

Title

Excessive Daytime Sleepiness assessment

Description

Excessive Daytime Sleepiness assessment by evaluation of ESS score, and other questionnaires.

Time Frame

At week 7

Title

Safety assessment

Description

Safety assessment thanks to AE recording, vitals signs assessment, ECG...

Time Frame

11 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Evelyne De Paillette, Dr

Organizational Affiliation

Bioprojet

Official's Role

Study Director

Facility Information:

Facility Name

State Health Center

City

Budapest

ZIP/Postal Code

1134

Country

Hungary

12. IPD Sharing Statement

Citations:

PubMed Identifier

34935103

Citation

Meskill GJ, Davis CW, Zarycranski D, Doliba M, Schwartz JC, Dayno JM. Clinical Impact of Pitolisant on Excessive Daytime Sleepiness and Cataplexy in Adults With Narcolepsy: An Analysis of Randomized Placebo-Controlled Trials. CNS Drugs. 2022 Jan;36(1):61-69. doi: 10.1007/s40263-021-00886-x. Epub 2021 Dec 21.

Results Reference

derived

PubMed Identifier

34822113

Citation

Watson NF, Davis CW, Zarycranski D, Vaughn B, Dayno JM, Dauvilliers Y, Schwartz JC. Time to Onset of Response to Pitolisant for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Patients With Narcolepsy: An Analysis of Randomized, Placebo-Controlled Trials. CNS Drugs. 2021 Dec;35(12):1303-1315. doi: 10.1007/s40263-021-00866-1. Epub 2021 Nov 25.

Results Reference

derived

PubMed Identifier

28129985

Citation

Szakacs Z, Dauvilliers Y, Mikhaylov V, Poverennova I, Krylov S, Jankovic S, Sonka K, Lehert P, Lecomte I, Lecomte JM, Schwartz JC; HARMONY-CTP study group. Safety and efficacy of pitolisant on cataplexy in patients with narcolepsy: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017 Mar;16(3):200-207. doi: 10.1016/S1474-4422(16)30333-7. Epub 2017 Jan 25.

Results Reference

derived

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

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