Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy - Full Text View

Purpose

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)

Condition	Intervention	Phase
Narcolepsy Excessive Daytime Sleepiness Cataplexy Sleep Disorders	Drug: BF2.649 Drug: Modafinil Drug: Placebo	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, Placebo-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in Treatment of Excessive Daytime Sleepiness in Narcolepsy

Resource links provided by NLM:

Genetics Home Reference related topics: narcolepsy

MedlinePlus related topics: Sleep Disorders

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:

Epworth Sleepiness Scale (ESS) [ Time Frame: between baseline and at the end of 8 week DB phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sleep Diary: Number and duration of diurnal sleep and sleepiness episodes, number of cataplexy attacks [ Time Frame: 14 days before randomization and 7 days before each visit ] [ Designated as safety issue: No ]
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 ]


Enrollment:	110
Study Start Date:	May 2009
Study Completion Date:	December 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BF2.649	Drug: BF2.649 BF2.649 oral capsules at 10 or 20 or 40 mg per day Other Name: Pitolisant
Active Comparator: Modafinil	Drug: Modafinil Modafinil oral capsules at 100 or 200 or 400 mg per day Other Name: Modiodal
Placebo Comparator: Placebo	Drug: Placebo Placebo oral capsules, 4 capsules per day

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.

Eligibility


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

Criteria

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

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: NCT01067222

Locations


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

Sponsors and Collaborators

Bioprojet

Investigators


Principal Investigator:	Claudio Bassetti	Neurocenter (EOC) of Southern Switzerland, Lugano, Switzerland

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dauvilliers Y, Bassetti C, Lammers GJ, Arnulf I, Mayer G, Rodenbeck A, Lehert P, Ding CL, Lecomte JM, Schwartz JC; HARMONY I study group. Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial. Lancet Neurol. 2013 Nov;12(11):1068-75. doi: 10.1016/S1474-4422(13)70225-4. Epub 2013 Oct 7.


Responsible Party:	Bioprojet
ClinicalTrials.gov Identifier:	NCT01067222 History of Changes
Other Study ID Numbers:	P07-03 / BF2.649 2008-007866-46
Study First Received:	February 9, 2010
Last Updated:	June 8, 2012
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:


Narcolepsy Excessive daytime Sleepiness Cataplexy Sleep Disorders	Sleep attacks Orphan Drug Pitolisant

Additional relevant MeSH terms:


Sleep Wake Disorders Parasomnias Narcolepsy Cataplexy Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders Disorders of Excessive Somnolence Sleep Disorders, Intrinsic	Dyssomnias 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 28, 2016

Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy (Harmony1)