BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS
Phase 3
Completed
- Conditions
- Excessive Daytime SleepinessObstructive Sleep Apnea
- Interventions
- Drug: Placebo
- Registration Number
- NCT01071876
- 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
- 244
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Capsules of Placebo containing lactose with low, medium and high dosage BF2.649 BF2.649 BF2.649 capsules dosed at 5mg, 10 mg, 20mg
- Primary Outcome Measures
Name Time Method ESS change (Epworth Sleepiness Scale) at week 12 /52 versus baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHU Grenoble
🇫🇷Grenoble, France