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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01067222
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : June 11, 2012
Sponsor:
Information provided by (Responsible Party):
Bioprojet

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Narcolepsy Excessive Daytime Sleepiness Cataplexy Sleep Disorders Drug: BF2.649 Drug: Modafinil Drug: Placebo Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
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
Study Start Date : May 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Modafinil

Arms and Interventions
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Arm Intervention/treatment
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


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

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

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:

  • 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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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): NCT01067222


Locations
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Switzerland
Neurocenter (EOC) of Southern Switzerland
Lugano, Switzerland, 6903
Sponsors and Collaborators
Bioprojet
Investigators
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Principal Investigator: Claudio Bassetti Neurocenter (EOC) of Southern Switzerland, Lugano, Switzerland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT01067222    
Other Study ID Numbers: P07-03 / BF2.649
2008-007866-46 ( EudraCT Number )
First Posted: February 11, 2010    Key Record Dates
Last Update Posted: June 11, 2012
Last Verified: June 2012
Keywords provided by Bioprojet:
Narcolepsy
Excessive daytime Sleepiness
Cataplexy
Sleep Disorders
 Sleep attacks
Orphan Drug
Pitolisant
Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Narcolepsy
Cataplexy
Sleepiness
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Disorders of Excessive Somnolence
 Sleep Disorders, Intrinsic
Dyssomnias
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action