Trial | NCT01067222  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    110
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)
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.
Study Started
May 31
2009
Primary Completion
Jul 31
2010
Study Completion
Dec 31
2010
Last Update
Jun 11
2012
Estimate

Drug BF2.649

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

  • Other names: Pitolisant

Drug Modafinil

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

  • Other names: Modiodal

Drug Placebo

Placebo oral capsules, 4 capsules per day

Modafinil Active Comparator

Placebo Placebo Comparator

BF2.649 Experimental

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
No Results Posted