BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP. (HAROSA2)
This study is ongoing, but not recruiting participants.
Sponsor:
Bioprojet
Information provided by (Responsible Party):
Bioprojet
ClinicalTrials.gov Identifier:
NCT01072968
First received: February 19, 2010
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Obstructive Sleep Apnea Excessive Daytime Sleepiness |
Drug: BF2.649 Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Bioprojet:
Primary Outcome Measures:
- ESS (Epworth Sleepiness Scale) change from baseline [ Time Frame: From baseline to week 12 and week 51 ] [ Designated as safety issue: No ]
| Enrollment: | 268 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BF2.649
BF2.649 capsules dosed at 5 mg, 10 mg, 20 mg
|
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
|
Drug: Placebo
1 capsule per day in the morning before the breakfast
Other Name: placebo
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Bioprojet |
| ClinicalTrials.gov Identifier: | NCT01072968 History of Changes |
| Other Study ID Numbers: | P09-09 / BF2.649 |
| Study First Received: | February 19, 2010 |
| Last Updated: | May 15, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Spain: Spanish Agency of Medicines Belgium: Federal Agency for Medicinal Products and Health Products Denmark: Danish Medicines Agency Sweden: Medical Products Agency Finland: Finnish Medicines Agency Bulgaria: Bulgarian Drug Agency Macedonia: Ministry of Health Serbia and Montenegro: Agency for Drugs and Medicinal Devices |
Keywords provided by Bioprojet:
|
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 |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013