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

Purpose

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

Condition	Intervention	Phase
Narcolepsy Cataplexy Excessive Daytime Sleepiness	Drug: BF2.649 Drug: BF2.649 add on Modafinil	Phase 3


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

Resource links provided by NLM:

Genetics Home Reference related topics: narcolepsy

Drug Information available for: Modafinil Armodafinil

Genetic and Rare Diseases Information Center resources: Narcolepsy

U.S. FDA Resources

Further study details as provided by Bioprojet:

Primary Outcome Measures:

Cataplexy attacks reported on sleep diary [ Time Frame: every days from screening visit (day-14) to final visit (day 56) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: Yes ]
Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART). [ Time Frame: at inclusion and after 8-week treatment ] [ Designated as safety issue: No ]
Epworth Sleepiness Scale (ESS) [ Time Frame: at each visit ] [ Designated as safety issue: No ]


Enrollment:	14
Study Start Date:	October 2009
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BF2.649 + Modafinil placebo	Drug: BF2.649 BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks Other Name: Pitolisant
Experimental: BF2.649 + Modafinil	Drug: 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 Other Names: Pitolisant Modiodal

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067235

Locations


Switzerland
Neurocenter (EOC) of Southern Switzerland
Lugano, Switzerland, 6903

Sponsors and Collaborators

Bioprojet

Investigators


Principal Investigator:	Claudio Bassetti	Neurocenter of Southern Switzerland,Lugano

More Information


Responsible Party:	Bioprojet
ClinicalTrials.gov Identifier:	NCT01067235 History of Changes
Other Study ID Numbers:	P07-07 / BF2.649 2008-007845-29
Study First Received:	February 9, 2010
Last Updated:	February 8, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Switzerland: Swissmedic Hungary: National Institute of Pharmacy Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Bioprojet:


Narcolespy Cataplexy Excesssive daytime Sleepiness Sleep Disorders	Sleep attacks Orphan Drug Pitolisant

Additional relevant MeSH terms:


Narcolepsy Cataplexy Disorders of Excessive Somnolence Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders	Modafinil Armodafinil Wakefulness-Promoting Agents Central Nervous System Stimulants Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016

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