Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
Conditions
Keywords
Narcolespy, Cataplexy, Excesssive daytime Sleepiness, Sleep Disorders, Sleep attacks, Orphan Drug, Pitolisant
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.
Interventions
DRUGBF2.649
BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks
DRUGBF2.649 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
Sponsors
Bioprojet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cataplexy attacks reported on sleep diary | every days from screening visit (day-14) to final visit (day 56) |
Secondary
| Measure | Time frame |
|---|---|
| Sleep Diary: number and duration of diurnal sleep and sleepiness episodes, | every days from screening visit (day-14) to final visit (day 56) |
| Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART). | at inclusion and after 8-week treatment |
| Epworth Sleepiness Scale (ESS) | at each visit |
Countries
Switzerland
Outcome results
None listed