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

Sleep Disorders Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067222
• Other study ID #: P07-03 / BF2.649
• Secondary ID: 2008-007866-46
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2010
• Last updated: June 8, 2012
• Start date: May 2009
• Est. completion date: December 2010

Study information

• Verified date: June 2012
• Source: Bioprojet
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesSwitzerland: SwissmedicHungary: National Institute of PharmacyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataplexy
• Excessive Daytime Sleepiness
• Narcolepsy
• Parasomnias
• Sleep Disorders

Intervention

Drug:
• BF2.649
BF2.649 oral capsules at 10 or 20 or 40 mg per day
• Modafinil
Modafinil oral capsules at 100 or 200 or 400 mg per day
• Placebo
Placebo oral capsules, 4 capsules per day

Locations

Country	Name	City	State
Switzerland	Neurocenter (EOC) of Southern Switzerland	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Bioprojet

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epworth Sleepiness Scale (ESS)		between baseline and at the end of 8 week DB phase	No
Secondary	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	No
Secondary	Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).		at inclusion and after 8-week treatment	No