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

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

Condition Intervention Phase
Narcolepsy Excessive Daytime Sleepiness Cataplexy Sleep Disorders Drug: BF2.649 Drug: Modafinil Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Bioprojet:

Primary Outcome Measures:
  • Epworth Sleepiness Scale (ESS) [ Time Frame: between baseline and at the end of 8 week DB phase ]

Secondary Outcome Measures:
  • 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 ]
  • Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART). [ Time Frame: at inclusion and after 8-week treatment ]

Enrollment: 110
Study Start Date: May 2009
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BF2.649 Drug: BF2.649
BF2.649 oral capsules at 10 or 20 or 40 mg per day
Other Name: Pitolisant
Active Comparator: Modafinil Drug: Modafinil
Modafinil oral capsules at 100 or 200 or 400 mg per day
Other Name: Modiodal
Placebo Comparator: Placebo Drug: Placebo
Placebo oral capsules, 4 capsules per day

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01067222

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bioprojet Identifier: NCT01067222     History of Changes
Other Study ID Numbers: P07-03 / BF2.649
2008-007866-46 ( EudraCT Number )
Study First Received: February 9, 2010
Last Updated: June 8, 2012

Keywords provided by Bioprojet:
Excessive daytime Sleepiness
Sleep Disorders
Sleep attacks
Orphan Drug

Additional relevant MeSH terms:
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
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 processed this record on September 19, 2017