Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy (Harmony2)
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ClinicalTrials.gov Identifier: NCT01067235 |
Recruitment Status
:
Completed
First Posted
: February 11, 2010
Last Update Posted
: February 11, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Narcolepsy Cataplexy Excessive Daytime Sleepiness | Drug: BF2.649 Drug: BF2.649 add on Modafinil | Phase 3 |
BF 2.649, a new molecule, reduces significantly the diurnal sleepiness and demonstrated its anti-cataplexy effect in pre-clinical and clinical studies.
The objective of this POC study are firstly to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil (200 mg/day) on cataplexy attacks, and secondly to evaluate the additive/synergistic effect and safety of the combination of BF2.649 and Modafinil on EDS as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Prospective, Randomized, Double-blind Study, Parallel-group, Multi-center Trial Assessing the Effects of Escalating Doses of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolepsy |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | July 2010 |
Actual Study Completion Date : | July 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: BF2.649 + Modafinil placebo |
Drug: BF2.649
BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks
Other Name: Pitolisant
|
Experimental: BF2.649 + Modafinil |
Drug: BF2.649 add on Modafinil
BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil capsules at 200 mg per day for 8 weeks
Other Names:
|
- Cataplexy attacks reported on sleep diary [ Time Frame: every days from screening visit (day-14) to final visit (day 56) ]
- Sleep Diary: number and duration of diurnal sleep and sleepiness episodes, [ Time Frame: every days from screening visit (day-14) to final visit (day 56) ]
- Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART). [ Time Frame: at inclusion and after 8-week treatment ]
- Epworth Sleepiness Scale (ESS) [ Time Frame: at each visit ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- "De novo" patients with newly diagnosed narcolespy and cataplexy , and not taking any treatment for Excessive Daytime Sleepiness(EDS) and cataplexy
- patients with previously diagnosed narcolepsy and cataplexy and not taking any treatment for EDS and cataplexy for more than 3 months
- partial or total cataplexy attacks with a frequency of at least 5 per week during a 14 day baseline period and ESS >or= 14 at the end of the baseline period
Exclusion Criteria:
- Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
- Current or recent history of a substance abuse or dependence disorder including alcohol abuse
- 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

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): NCT01067235
Switzerland | |
Neurocenter (EOC) of Southern Switzerland | |
Lugano, Switzerland, 6903 |
Principal Investigator: | Claudio Bassetti | Neurocenter of Southern Switzerland,Lugano |
Responsible Party: | Bioprojet |
ClinicalTrials.gov Identifier: | NCT01067235 History of Changes |
Other Study ID Numbers: |
P07-07 / BF2.649 2008-007845-29 ( EudraCT Number ) |
First Posted: | February 11, 2010 Key Record Dates |
Last Update Posted: | February 11, 2013 |
Last Verified: | June 2012 |
Keywords provided by Bioprojet:
Narcolespy Cataplexy Excesssive daytime Sleepiness Sleep Disorders |
Sleep attacks Orphan Drug Pitolisant |
Additional relevant MeSH terms:
Narcolepsy Cataplexy Disorders of Excessive Somnolence Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders |
Modafinil Armodafinil 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 |