Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy (Harmony1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bioprojet
ClinicalTrials.gov Identifier:
NCT01067222
First received: February 9, 2010
Last updated: June 8, 2012
Last verified: June 2012

February 9, 2010
June 8, 2012
May 2009
July 2010   (final data collection date for primary outcome measure)
Epworth Sleepiness Scale (ESS) [ Time Frame: between baseline and at the end of 8 week DB phase ] [ Designated as safety issue: No ]
Epworth Sleepiness Scale (ESS) [ Time Frame: at each visit ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01067222 on ClinicalTrials.gov Archive Site
  • Sleep Diary: Number and duration of diurnal sleep and sleepiness episodes, number of cataplexy attacks [ Time Frame: 14 days before randomization and 7 days before each visit ] [ Designated as safety issue: No ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy
Prospective, Randomized, Double-blind Study, Placebo-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in Treatment of Excessive Daytime Sleepiness in Narcolepsy

The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (EDS)

BF 2.649, a new experimental drug, significantly decreases, in patient with narcolepsy, the excessive daytime sleepiness (EDS) evaluated by Epworth Sleepiness Scale (ESS), according the results of two previous clinical studies.

The objective of this study is to determine the efficacy and safety of BF2.649 administered by escalating dose (10, 20 or 40 mg/d) in narcoleptic patients with excessive daytime sleepiness versus placebo and Modafinil as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.

60 patients with narcolepsy with or without cataplexy will be included.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Narcolepsy
  • Excessive Daytime Sleepiness
  • Cataplexy
  • Sleep Disorders
  • Drug: BF2.649
    BF2.649 oral capsules at 10 or 20 or 40 mg per day
    Other Name: Pitolisant
  • Drug: Modafinil
    Modafinil oral capsules at 100 or 200 or 400 mg per day
    Other Name: Modiodal
  • Drug: Placebo
    Placebo oral capsules, 4 capsules per day
    Other Name: placebo
  • Experimental: BF2.649
    Intervention: Drug: BF2.649
  • Active Comparator: Modafinil
    Intervention: Drug: Modafinil
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
December 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of narcolepsy with or without cataplexy
  • patients need to free of or discontinue psychostimulant medications for at least 14 days,
  • patients with severe cataplexy are permitted to remain on their anticataplectic medications at stable doses
  • patients must have adequate support to comply with the entire study requirements

Exclusion Criteria:

  • Other conditions than Narcolepsy that can be considered as the primary causes of excessive daytime sleepiness
  • Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
  • 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
  • Current or recent history of a substance abuse or dependence disorder including alcohol abuse
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01067222
P07-03 / BF2.649, 2008-007866-46
No
Bioprojet
Bioprojet
Not Provided
Principal Investigator: Claudio Bassetti Neurocenter (EOC) of Southern Switzerland, Lugano, Switzerland
Bioprojet
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP