Clinical trial NCT01067235: Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Narcolepsy
Cataplexy
Excessive Daytime Sleepiness
Keywords: Narcolespy
Cataplexy
Excesssive daytime Sleepiness
Sleep Disorders
Sleep attacks
Orphan Drug
Pitolisant
Lead sponsor: Bioprojet
Sponsor class: OTHER
First posted: 2010-02-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Cataplexy attacks reported on sleep diary
timeFrame: every days from screening visit (day-14) to final visit (day 56)
Secondary outcomes:
measure: Sleep Diary: number and duration of diurnal sleep and sleepiness episodes,
timeFrame: every days from screening visit (day-14) to final visit (day 56)
measure: Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).
timeFrame: at inclusion and after 8-week treatment
measure: Epworth Sleepiness Scale (ESS)
timeFrame: at each visit
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Neurocenter (EOC) of Southern Switzerland
Study officials:
affiliation: Neurocenter of Southern Switzerland,Lugano
name: Claudio Bassetti
role: PRINCIPAL_INVESTIGATOR
References: