Minimum effective dose-finding study of BF2.649, in patients with moderate to severe Obstructive Sleep Apnea, experiencing Excessive Daytime Sleepiness (EDS) despite regular use of nCPAP, and patients having refused this therapy. Randomized, double blind study with BF2.649 (5-, 10-, 20-, 40- mg/d), or placebo
- Conditions
- Treatment of excessive daytime sleepiness associated to obstructive sleep apneaMedDRA version: 12.1Level: LLTClassification code 10055577Term: Obstructive sleep apnea syndrome
- Registration Number
- EUCTR2010-019413-25-FR
- Lead Sponsor
- Bioprojet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
- Patients having been submitted to nCPAP therapy for a minimum period of 3 months, and still complaining of Excessive Daytime Sleepiness despite the efforts made beforehand to obtain an efficient nCPAP therapy on Excessive Daytime Sleepiness (EDS) (group A)
- Patients with OSA, complaining of Excessive Daytime Sleepiness but refusing to be treated by nCPAP therapy (group B)
- Epworth score = 11
- Patients having signed the informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Patient suffering from chronic severe insomnia in accordance with the International Classification of Sleep Disorders, but without OSA (ICSD 2005): Patient with narcolepsy - sleep debt not due to OSA (according to the physician‘s judgment) – non respiratory sleep fragmentation (Periodic legs movement…)
- Patient suffering from a psychiatric disease
- Severe comorbid medical or biological conditions that may jeopardize study participation at the discretion of the investigator
- Positive beta HCG pregnant test or breast-feeding women
- Women with child-bearing potential and no efficient birth-control method
- Patient unable to understand and comply with the study protocol
-Positive serology testes – HCV – HBsAg and HIV (optional)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy and the safety of BF2.649 on the excessive daytime sleepiness in OSA patients and to determine the minimum effective dose (MED);Secondary Objective: - To assess the percentage of responders to treatment<br>- To evaluate the reduction of sleepiness and sleep episodes on the sleep diary<br>- To assess the Improvement in CGI (Assessment of illness severity)<br>;Primary end point(s): Epworth Sleepiness Scale scores (ESS) on the 14-day treatment period
- Secondary Outcome Measures
Name Time Method