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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2010

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.

Interventions

  • Drug: BF2.649
    • BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks
  • Drug: BF2.649 add on Modafinil
    • BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil capsules at 200 mg per day for 8 weeks

Arms, Groups and Cohorts

  • Experimental: BF2.649 + Modafinil placebo
  • Experimental: BF2.649 + Modafinil

Clinical Trial Outcome Measures

Primary Measures

  • Cataplexy attacks reported on sleep diary
    • Time Frame: every days from screening visit (day-14) to final visit (day 56)

Secondary Measures

  • Sleep Diary: number and duration of diurnal sleep and sleepiness episodes,
    • Time Frame: every days from screening visit (day-14) to final visit (day 56)
  • Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).
    • Time Frame: at inclusion and after 8-week treatment
  • Epworth Sleepiness Scale (ESS)
    • Time Frame: at each visit

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bioprojet
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Claudio Bassetti, Principal Investigator, Neurocenter of Southern Switzerland,Lugano

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