BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP. (HAROSA2)
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ClinicalTrials.gov Identifier: NCT01072968 |
Recruitment Status :
Completed
First Posted : February 22, 2010
Last Update Posted : January 21, 2015
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Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose.
This double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obstructive Sleep Apnea Excessive Daytime Sleepiness | Drug: BF2.649 Drug: Placebo | Phase 3 |
The first period (12 weeks double blind period) will aim at demonstrating the efficacy and safety of BF2.649 by verifying whether the results of BF2.649 are superior to those of placebo.
The aim of the second period (open label extension phase) will be to assess the long-term tolerance, as well as the maintenance of the BF2.649 efficacy.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 268 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of BF2.649 in Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea (OSA) Refusing the Nasal Continuous Positive Airway Pressure (nCPAP) Therapy |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: BF2.649
BF2.649 capsules dosed at 5 mg, 10 mg, 20 mg
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Drug: BF2.649
1 capsule per day in the morning before the breakfast
Other Name: Pitolisant |
Placebo Comparator: Placebo
Capsules of placebo containing lactose with low, medium and high dosage
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Drug: Placebo
1 capsule per day in the morning before the breakfast |
- ESS (Epworth Sleepiness Scale) change from baseline [ Time Frame: From baseline to week 12 and week 51 ]

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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:
- Patients with OSA still complaining EDS,refusing nCPAP
- ESS score ≥ 12
Exclusion Criteria:
- Patients suffering from insomnia without OSA
- Co-existing narcolepsy
- Patient with sleep debt not due to OSA
- Acute or chronic severe disease

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): NCT01072968
France | |
Centre Hospitalier Universitaire de Grenoble | |
Grenoble, France, 38043 |
Study Director: | Evelyne De Paillette, MD | Bioprojet |
Responsible Party: | Bioprojet |
ClinicalTrials.gov Identifier: | NCT01072968 |
Other Study ID Numbers: |
P09-09 / BF2.649 |
First Posted: | February 22, 2010 Key Record Dates |
Last Update Posted: | January 21, 2015 |
Last Verified: | January 2015 |
Multicenter Randomized Double-blind Efficacy and safety study |
BF2.649 versus placebo Patients suffering from Obstructive Sleep Apnea Complaining from Excessive Daytime Sleepiness Refusing nasal Continuous Positive Airway Pressure |
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Disorders of Excessive Somnolence Sleepiness Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders |