BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP.
Phase 3
Completed
- Conditions
- Obstructive Sleep ApneaExcessive Daytime Sleepiness
- Interventions
- Drug: Placebo
- Registration Number
- NCT01072968
- Lead Sponsor
- Bioprojet
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 268
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BF2.649 BF2.649 BF2.649 capsules dosed at 5 mg, 10 mg, 20 mg Placebo Placebo Capsules of placebo containing lactose with low, medium and high dosage
- Primary Outcome Measures
Name Time Method ESS (Epworth Sleepiness Scale) change from baseline From baseline to week 12 and week 51
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire de Grenoble
🇫🇷Grenoble, France