Overview

Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy

Status:
Completed
Trial end date:
2010-07-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bioprojet
Treatments:
Armodafinil
Modafinil
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