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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01067235
Other study ID # P07-07 / BF2.649
Secondary ID 2008-007845-29
Status Completed
Phase Phase 3
First received February 9, 2010
Last updated February 8, 2013
Start date October 2009
Est. completion date July 2010

Study information

Verified date June 2012
Source Bioprojet
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesSwitzerland: SwissmedicHungary: National Institute of PharmacyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Switzerland Neurocenter (EOC) of Southern Switzerland Lugano

Sponsors (1)

Lead Sponsor Collaborator
Bioprojet

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cataplexy attacks reported on sleep diary every days from screening visit (day-14) to final visit (day 56) Yes
Secondary Sleep Diary: number and duration of diurnal sleep and sleepiness episodes, every days from screening visit (day-14) to final visit (day 56) Yes
Secondary Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART). at inclusion and after 8-week treatment No
Secondary Epworth Sleepiness Scale (ESS) at each visit No
See also
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Completed NCT01681121 - A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy Phase 2
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