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

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ClinicalTrials.gov Identifier: NCT01067235
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : February 11, 2013
Sponsor:
Information provided by (Responsible Party):
Bioprojet

Study Description
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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

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

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Cataplexy attacks reported on sleep diary [ Time Frame: every days from screening visit (day-14) to final visit (day 56) ]

Secondary Outcome Measures :
  1. 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) ]
  2. Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART). [ Time Frame: at inclusion and after 8-week treatment ]
  3. Epworth Sleepiness Scale (ESS) [ Time Frame: at each visit ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT01067235     History of Changes
Other Study ID Numbers: P07-07 / BF2.649
2008-007845-29 ( EudraCT Number )
First Posted: February 11, 2010    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: June 2012

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 Wake Disorders
Nervous System Diseases
Mental Disorders
 Modafinil
Armodafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs