BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS (HAROSA1)
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ClinicalTrials.gov Identifier: NCT01071876 |
Recruitment Status :
Completed
First Posted : February 19, 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 : | 244 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | BF2.649 in Patients With Obstructive Sleep Apnea Syndrome (OSA) and Treated by Nasal Continuous Positive Airway Pressure (nCPAP), But Still Complaining of Excessive Daytime Sleepiness (EDS) |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | March 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: BF2.649
BF2.649 capsules dosed at 5mg, 10 mg, 20mg
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Drug: BF2.649
1 capsule in the morning before 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 in the morning before breakfast |
- ESS change (Epworth Sleepiness Scale) [ Time Frame: at week 12 /52 versus baseline ]

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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 treated by nCPAP but still complaining with EDS
- ESS score > or = 12
Exclusion Criteria:
- patient 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): NCT01071876
France | |
CHU Grenoble | |
Grenoble, France |
Study Director: | Evelyne De Paillette, MD | Bioprojet |
Responsible Party: | Bioprojet |
ClinicalTrials.gov Identifier: | NCT01071876 |
Other Study ID Numbers: |
P09-08 / BF2.649 2009-017248-14 ( EudraCT Number ) |
First Posted: | February 19, 2010 Key Record Dates |
Last Update Posted: | January 21, 2015 |
Last Verified: | January 2015 |
Sleep disorder obstructive sleep apnea excessive daytime sleepiness patients with OSA treated by CPAP presenting EDS |
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 |