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

Phase 3

Completed

• Conditions: Sleep Disorders; Cataplexy; Narcolepsy; Excessive Daytime Sleepiness
• Interventions: Drug: BF2.649; Drug: Placebo; Drug: Modafinil

• Registration Number: NCT01067222
• Lead Sponsor: Bioprojet

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.

Study Timeline

• Study Start: 2009-05
• 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: 2010-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-08
• Last Update Posted: 2012-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BF2.649	BF2.649	-
Placebo	Placebo	-
Modafinil	Modafinil	-

Primary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale (ESS)	between baseline and at the end of 8 week DB phase

Secondary Outcome Measures

Name	Time	Method
Sleep Diary: Number and duration of diurnal sleep and sleepiness episodes, number of cataplexy attacks	14 days before randomization and 7 days before each visit
Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).	at inclusion and after 8-week treatment

Trial Locations

Locations (1)

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