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

Phase 3

Completed

• Conditions: Narcolepsy; Cataplexy; Excessive Daytime Sleepiness
• Interventions: Drug: BF2.649; Drug: BF2.649 add on Modafinil

• Registration Number: NCT01067235
• Lead Sponsor: Bioprojet

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-10
• Study First Posted: 2010-02-11
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2012-06
• Last Update Submitted: 2013-02-08
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BF2.649 + Modafinil placebo	BF2.649	-
BF2.649 + Modafinil	BF2.649 add on Modafinil	-

Primary Outcome Measures

Name	Time	Method
Cataplexy attacks reported on sleep diary	every days from screening visit (day-14) to final visit (day 56)

Secondary Outcome Measures

Name	Time	Method
Sleep Diary: number and duration of diurnal sleep and sleepiness episodes,	every days from screening visit (day-14) to final visit (day 56)
Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).	at inclusion and after 8-week treatment
Epworth Sleepiness Scale (ESS)	at each visit

Trial Locations

Locations (1)

Neurocenter (EOC) of Southern Switzerland; 🇨🇭 Lugano, Switzerland