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Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy (Harmony2)

Primary Purpose

Narcolepsy, Cataplexy, Excessive Daytime Sleepiness

Status

Completed

Phase

Phase 3

Locations

Switzerland

Study Type

Interventional

Intervention

BF2.649

BF2.649 add on Modafinil

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

"De novo" patients with newly diagnosed narcolespy and cataplexy , and not taking any treatment for Excessive Daytime Sleepiness(EDS) and cataplexy
patients with previously diagnosed narcolepsy and cataplexy and not taking any treatment for EDS and cataplexy for more than 3 months
partial or total cataplexy attacks with a frequency of at least 5 per week during a 14 day baseline period and ESS >or= 14 at the end of the baseline period

Exclusion Criteria:

Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
Current or recent history of a substance abuse or dependence disorder including alcohol abuse
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

Sites / Locations

Neurocenter (EOC) of Southern Switzerland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

BF2.649 + Modafinil placebo

BF2.649 + Modafinil

Arm Description

Outcomes

Primary Outcome Measures

Cataplexy attacks reported on sleep diary

Secondary Outcome Measures

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

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

Epworth Sleepiness Scale (ESS)

Full Information

NCT ID

NCT01067235

First Posted

February 9, 2010

Last Updated

February 8, 2013

Sponsor

Bioprojet

1. Study Identification

Unique Protocol Identification Number

NCT01067235

Brief Title

Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy

Acronym

Harmony2

Official Title

Prospective, Randomized, Double-blind Study, Parallel-group, Multi-center Trial Assessing the Effects of Escalating Doses of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolepsy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 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 and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy

Detailed Description

BF 2.649, a new molecule, reduces significantly the diurnal sleepiness and demonstrated its anti-cataplexy effect in pre-clinical and clinical studies. The objective of this POC study are firstly to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil (200 mg/day) on cataplexy attacks, and secondly to evaluate the additive/synergistic effect and safety of the combination of BF2.649 and Modafinil on EDS as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.

6. Conditions and Keywords

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

Narcolepsy, Cataplexy, Excessive Daytime Sleepiness

Keywords

Narcolespy, Cataplexy, Excesssive daytime Sleepiness, 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

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BF2.649 + Modafinil placebo

Arm Type

Experimental

Arm Title

BF2.649 + Modafinil

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

BF2.649

Other Intervention Name(s)

Pitolisant

Intervention Description

BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks

Intervention Type

Drug

Intervention Name(s)

BF2.649 add on Modafinil

Other Intervention Name(s)

Pitolisant, Modiodal

Intervention Description

BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil capsules at 200 mg per day for 8 weeks

Primary Outcome Measure Information:

Title

Cataplexy attacks reported on sleep diary

Time Frame

every days from screening visit (day-14) to final visit (day 56)

Secondary Outcome Measure Information:

Title

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

Time Frame

every days from screening visit (day-14) to final visit (day 56)

Title

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

Time Frame

at inclusion and after 8-week treatment

Title

Epworth Sleepiness Scale (ESS)

Time Frame

at each visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: "De novo" patients with newly diagnosed narcolespy and cataplexy , and not taking any treatment for Excessive Daytime Sleepiness(EDS) and cataplexy patients with previously diagnosed narcolepsy and cataplexy and not taking any treatment for EDS and cataplexy for more than 3 months partial or total cataplexy attacks with a frequency of at least 5 per week during a 14 day baseline period and ESS >or= 14 at the end of the baseline period Exclusion Criteria: Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances Current or recent history of a substance abuse or dependence disorder including alcohol abuse 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claudio Bassetti

Organizational Affiliation

Neurocenter of Southern Switzerland,Lugano

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

Learn more about this trial

Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy

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