Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy
Information source: Bioprojet
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Narcolepsy; Cataplexy; Excessive Daytime Sleepiness
Intervention: BF2.649 (Drug); BF2.649 add on Modafinil (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bioprojet Official(s) and/or principal investigator(s): Claudio Bassetti, Principal Investigator, Affiliation: Neurocenter of Southern Switzerland,Lugano
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
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Cataplexy attacks reported on sleep diary
Secondary outcome: Sleep Diary: number and duration of diurnal sleep and sleepiness episodes,Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART). Epworth Sleepiness Scale (ESS)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Neurocenter (EOC) of Southern Switzerland, Lugano 6903, Switzerland
Additional Information
Starting date: October 2009
Last updated: February 8, 2013
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