- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01067222
Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy (Harmony1)
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 Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Lugano, Switzerland, 6903
- Neurocenter (EOC) of Southern Switzerland
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
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Placebo oral capsules, 4 capsules per day
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EXPERIMENTAL: BF2.649
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BF2.649 oral capsules at 10 or 20 or 40 mg per day
Other Names:
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ACTIVE_COMPARATOR: Modafinil
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Modafinil oral capsules at 100 or 200 or 400 mg per day
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Epworth Sleepiness Scale (ESS)
Time Frame: between baseline and at the end of 8 week DB phase
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between baseline and at the end of 8 week DB phase
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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14 days before randomization and 7 days before each visit
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Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).
Time Frame: at inclusion and after 8-week treatment
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at inclusion and after 8-week treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Claudio Bassetti, Neurocenter (EOC) of Southern Switzerland, Lugano, Switzerland
Publications and helpful links
General Publications
- Meskill GJ, Davis CW, Zarycranski D, Doliba M, Schwartz JC, Dayno JM. Clinical Impact of Pitolisant on Excessive Daytime Sleepiness and Cataplexy in Adults With Narcolepsy: An Analysis of Randomized Placebo-Controlled Trials. CNS Drugs. 2022 Jan;36(1):61-69. doi: 10.1007/s40263-021-00886-x. Epub 2021 Dec 21.
- Watson NF, Davis CW, Zarycranski D, Vaughn B, Dayno JM, Dauvilliers Y, Schwartz JC. Time to Onset of Response to Pitolisant for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Patients With Narcolepsy: An Analysis of Randomized, Placebo-Controlled Trials. CNS Drugs. 2021 Dec;35(12):1303-1315. doi: 10.1007/s40263-021-00866-1. Epub 2021 Nov 25.
- Dauvilliers Y, Bassetti C, Lammers GJ, Arnulf I, Mayer G, Rodenbeck A, Lehert P, Ding CL, Lecomte JM, Schwartz JC; HARMONY I study group. Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial. Lancet Neurol. 2013 Nov;12(11):1068-75. doi: 10.1016/S1474-4422(13)70225-4. Epub 2013 Oct 7.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Neurologic Manifestations
- Sleep Wake Disorders
- Parasomnias
- Disorders of Excessive Somnolence
- Sleepiness
- Narcolepsy
- Cataplexy
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Central Nervous System Stimulants
- Wakefulness-Promoting Agents
- Modafinil
Other Study ID Numbers
- P07-03 / BF2.649
- 2008-007866-46 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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BioprojetCompletedNarcolepsy | CataplexyFrance
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BioprojetCompletedBF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP. (HAROSA2)Obstructive Sleep Apnea | Excessive Daytime SleepinessFrance
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BioprojetCompletedEfficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease (HARPS2)Parkinson's DiseaseGermany
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BioprojetCompletedObstructive Sleep Apnea | Excessive Daytime SleepinessBulgaria, North Macedonia