Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy (Harmony1)
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| ClinicalTrials.gov Identifier: NCT01067222 |
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Recruitment Status :
Completed
First Posted : February 11, 2010
Last Update Posted : June 11, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Narcolepsy Excessive Daytime Sleepiness Cataplexy Sleep Disorders | Drug: BF2.649 Drug: Modafinil Drug: Placebo | Phase 3 |
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 : | 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 |
| 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 |
- Epworth Sleepiness Scale (ESS) [ Time Frame: between baseline and at the end of 8 week DB phase ]
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
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
| Switzerland | |
| Neurocenter (EOC) of Southern Switzerland | |
| Lugano, Switzerland, 6903 | |
| Principal Investigator: | Claudio Bassetti | Neurocenter (EOC) of Southern Switzerland, Lugano, Switzerland |
| 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 |
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Narcolepsy Excessive daytime Sleepiness Cataplexy Sleep Disorders |
Sleep attacks Orphan Drug Pitolisant |
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Sleep Wake Disorders Parasomnias Narcolepsy Disorders of Excessive Somnolence Cataplexy Sleepiness Nervous System Diseases Neurologic Manifestations Mental Disorders |
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 |