Narcolepsy Clinical Trial
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
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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