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

Conditions

Narcolepsy, Excessive Daytime Sleepiness, Cataplexy, Sleep Disorders

Keywords

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

Brief summary

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)

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.

Gerard Meskill, Craig W. Davis, Donna Zarycranski, Nicolai M. Doliba, Jean‐Charles Schwartz et al. (6 authors)

CNS Drugs2021-12-2113 citations

10.1007/s40263-021-00886-x

Time to Onset of Response to Pitolisant for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Patients With Narcolepsy: An Analysis of Randomized, Placebo-Controlled Trials.

Watson NF, Davis CW, Zarycranski D, Vaughn B, Dayno JM, Dauvilliers Y, Schwartz JC.

2021-11-254 citations

10.1007/s40263-021-00866-1

Comparing Treatment Effect Measurements in Narcolepsy: The Sustained Attention to Response Task, Epworth Sleepiness Scale and Maintenance of Wakefulness Test.

van der Heide A, van Schie MK, Lammers GJ, Dauvilliers Y, Arnulf I, Mayer G, Bassetti CL, Ding CL, Lehert P, van Dijk JG.

2015-07-0144 citations

10.5665/sleep.4810

Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial.

Dauvilliers Y, Bassetti C, Lammers GJ, Arnulf I, Mayer G, Rodenbeck A, Lehert P, Ding CL, Lecomte JM, Schwartz JC, HARMONY I study group.

2013-10-07227 citations

10.1016/s1474-4422(13)70225-4

Interventions

DRUGBF2.649

BF2.649 oral capsules at 10 or 20 or 40 mg per day

DRUGModafinil

Modafinil oral capsules at 100 or 200 or 400 mg per day

DRUGPlacebo

Placebo oral capsules, 4 capsules per day

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

* 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

Design outcomes

Primary

Measure	Time frame
Epworth Sleepiness Scale (ESS)	between baseline and at the end of 8 week DB phase

Secondary

Measure	Time frame
Sleep Diary: Number and duration of diurnal sleep and sleepiness episodes, number of cataplexy attacks	14 days before randomization and 7 days before each visit
Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).	at inclusion and after 8-week treatment

Countries

Switzerland

Outcome results

None listed