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

NCT ID: NCT01067235

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-07-31

Brief 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

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.

Conditions

Narcolepsy; Cataplexy; Excessive Daytime Sleepiness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BF2.649 + Modafinil placebo

Group Type: EXPERIMENTAL

BF2.649

Intervention Type: DRUG

BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks

BF2.649 + Modafinil

Group Type: EXPERIMENTAL

BF2.649 add on Modafinil

Intervention Type: DRUG

BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil capsules at 200 mg per day for 8 weeks

Interventions

BF2.649

BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Pitolisant; Pitolisant; Modiodal

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioprojet

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudio Bassetti

Role: PRINCIPAL_INVESTIGATOR

Neurocenter of Southern Switzerland,Lugano

Locations

Neurocenter (EOC) of Southern Switzerland

Lugano, , Switzerland

Countries

Switzerland

Other Identifiers

2008-007845-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P07-07 / BF2.649

Identifier Type: -

Identifier Source: org_study_id