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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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

Condition or disease	Intervention/treatment	Phase
Narcolepsy; Cataplexy; Excessive Daytime Sleepiness	Drug: BF2.649; Drug: BF2.649 add on Modafinil	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	14 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, 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
Study Start Date :	October 2009
Actual Primary Completion Date :	July 2010
Actual Study Completion Date :	July 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Cataplexy attacks reported on sleep diary [ Time Frame: every days from screening visit (day-14) to final visit (day 56) ]

Secondary Outcome Measures :

1. 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) ]
2. Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART). [ Time Frame: at inclusion and after 8-week treatment ]
3. Epworth Sleepiness Scale (ESS) [ Time Frame: at each visit ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Bioprojet
ClinicalTrials.gov Identifier:	NCT01067235 History of Changes
Other Study ID Numbers:	P07-07 / BF2.649; 2008-007845-29 ( EudraCT Number )
First Posted:	February 11, 2010
Last Update Posted:	February 11, 2013
Last Verified:	June 2012

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