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Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy (Harmony1)

Primary Purpose

Narcolepsy, Excessive Daytime Sleepiness, Cataplexy

Status

Completed

Phase

Phase 3

Locations

Switzerland

Study Type

Interventional

Intervention

BF2.649

Modafinil

Placebo

About this trial

This is an interventional treatment trial for Narcolepsy focused on measuring Narcolepsy, Excessive daytime Sleepiness, Cataplexy, Sleep Disorders, Sleep attacks, Orphan Drug, Pitolisant

Eligibility Criteria

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

Inclusion Criteria:

diagnosis of narcolepsy with or without cataplexy
patients need to free of or discontinue psychostimulant medications for at least 14 days,
patients with severe cataplexy are permitted to remain on their anticataplectic medications at stable doses
patients must have adequate support to comply with the entire study requirements

Exclusion Criteria:

Other conditions than Narcolepsy that can be considered as the primary causes of excessive daytime sleepiness
Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
Psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigator's opinion would preclude the patient's participation
Current or recent history of a substance abuse or dependence disorder including alcohol abuse

Sites / Locations

Neurocenter (EOC) of Southern Switzerland

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

BF2.649

Modafinil

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Epworth Sleepiness Scale (ESS)

Secondary Outcome Measures

Sleep Diary: Number and duration of diurnal sleep and sleepiness episodes, number of cataplexy attacks

Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).

Full Information

NCT ID

NCT01067222

First Posted

February 9, 2010

Last Updated

June 8, 2012

Sponsor

Bioprojet

1. Study Identification

Unique Protocol Identification Number

NCT01067222

Brief Title

Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy

Acronym

Harmony1

Official Title

Prospective, Randomized, Double-blind Study, Placebo-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in Treatment of Excessive Daytime Sleepiness in Narcolepsy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bioprojet

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (EDS)

Detailed Description

BF 2.649, a new experimental drug, significantly decreases, in patient with narcolepsy, the excessive daytime sleepiness (EDS) evaluated by Epworth Sleepiness Scale (ESS), according the results of two previous clinical studies. The objective of this study is to determine the efficacy and safety of BF2.649 administered by escalating dose (10, 20 or 40 mg/d) in narcoleptic patients with excessive daytime sleepiness versus placebo and Modafinil as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary. 60 patients with narcolepsy with or without cataplexy will be included.

6. Conditions and Keywords

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

Narcolepsy, Excessive Daytime Sleepiness, Cataplexy, Sleep Disorders

Keywords

Narcolepsy, Excessive daytime Sleepiness, Cataplexy, Sleep Disorders, Sleep attacks, Orphan Drug, Pitolisant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BF2.649

Arm Type

Experimental

Arm Title

Modafinil

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

BF2.649

Other Intervention Name(s)

Pitolisant

Intervention Description

BF2.649 oral capsules at 10 or 20 or 40 mg per day

Intervention Type

Drug

Intervention Name(s)

Modafinil

Other Intervention Name(s)

Modiodal

Intervention Description

Modafinil oral capsules at 100 or 200 or 400 mg per day

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo oral capsules, 4 capsules per day

Primary Outcome Measure Information:

Title

Epworth Sleepiness Scale (ESS)

Time Frame

between baseline and at the end of 8 week DB phase

Secondary Outcome Measure Information:

Title

Sleep Diary: Number and duration of diurnal sleep and sleepiness episodes, number of cataplexy attacks

Time Frame

14 days before randomization and 7 days before each visit

Title

Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).

Time Frame

at inclusion and after 8-week treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: diagnosis of narcolepsy with or without cataplexy patients need to free of or discontinue psychostimulant medications for at least 14 days, patients with severe cataplexy are permitted to remain on their anticataplectic medications at stable doses patients must have adequate support to comply with the entire study requirements Exclusion Criteria: Other conditions than Narcolepsy that can be considered as the primary causes of excessive daytime sleepiness Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances Psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigator's opinion would preclude the patient's participation Current or recent history of a substance abuse or dependence disorder including alcohol abuse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claudio Bassetti

Organizational Affiliation

Neurocenter (EOC) of Southern Switzerland, Lugano, Switzerland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Neurocenter (EOC) of Southern Switzerland

City

Lugano

ZIP/Postal Code

6903

Country

Switzerland

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

24107292

Citation

Dauvilliers Y, Bassetti C, Lammers GJ, Arnulf I, Mayer G, Rodenbeck A, Lehert P, Ding CL, Lecomte JM, Schwartz JC; HARMONY I study group. Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial. Lancet Neurol. 2013 Nov;12(11):1068-75. doi: 10.1016/S1474-4422(13)70225-4. Epub 2013 Oct 7.

Results Reference

derived

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Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy

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