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

Narcolepsy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067235
• Other study ID #: P07-07 / BF2.649
• Secondary ID: 2008-007845-29
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2010
• Last updated: February 8, 2013
• Start date: October 2009
• Est. completion date: July 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 and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Drug:
• BF2.649
BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks
• BF2.649 add on Modafinil
BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil capsules at 200 mg per day for 8 weeks

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	Cataplexy attacks reported on sleep diary		every days from screening visit (day-14) to final visit (day 56)	Yes
Secondary	Sleep Diary: number and duration of diurnal sleep and sleepiness episodes,		every days from screening visit (day-14) to final visit (day 56)	Yes
Secondary	Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).		at inclusion and after 8-week treatment	No
Secondary	Epworth Sleepiness Scale (ESS)		at each visit	No