Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy (Harmony2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bioprojet
ClinicalTrials.gov Identifier:
NCT01067235
First received: February 9, 2010
Last updated: February 8, 2013
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Narcolepsy
Cataplexy
Excessive Daytime Sleepiness
Drug: BF2.649
Drug: BF2.649 add on Modafinil
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Bioprojet:

Primary Outcome Measures:
  • Cataplexy attacks reported on sleep diary [ Time Frame: every days from screening visit (day-14) to final visit (day 56) ] [ Designated as safety issue: Yes ]

Secondary Outcome 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) ] [ Designated as safety issue: Yes ]
  • Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART). [ Time Frame: at inclusion and after 8-week treatment ] [ Designated as safety issue: No ]
  • Epworth Sleepiness Scale (ESS) [ Time Frame: at each visit ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: October 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BF2.649 + Modafinil placebo Drug: BF2.649
BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks
Other Name: Pitolisant
Experimental: BF2.649 + Modafinil 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
Other Names:
  • Pitolisant
  • Modiodal

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067235

Locations
Switzerland
Neurocenter (EOC) of Southern Switzerland
Lugano, Switzerland, 6903
Sponsors and Collaborators
Bioprojet
Investigators
Principal Investigator: Claudio Bassetti Neurocenter of Southern Switzerland,Lugano
  More Information

No publications provided

Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT01067235     History of Changes
Other Study ID Numbers: P07-07 / BF2.649, 2008-007845-29
Study First Received: February 9, 2010
Last Updated: February 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic
Hungary: National Institute of Pharmacy
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Bioprojet:
Narcolespy
Cataplexy
Excesssive daytime Sleepiness
Sleep Disorders
Sleep attacks
Orphan Drug
Pitolisant

Additional relevant MeSH terms:
Narcolepsy
Cataplexy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014