E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of excessive daytime sleepiness associated to obstructive sleep apnea |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10055577 |
E.1.2 | Term | Obstructive sleep apnea syndrome |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
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E.2.2 | Secondary objectives of the trial |
- To assess the percentage of responders to treatment - To evaluate the reduction of sleepiness and sleep episodes on the sleep diary - To assess the Improvement in CGI (Assessment of illness severity)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 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
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E.4 | Principal exclusion criteria |
- 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)
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E.5 End points |
E.5.1 | Primary end point(s) |
Epworth Sleepiness Scale scores (ESS) on the 14-day treatment period |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last visit for the last patient included in the trial or the last visit before withdrawal for premature discontinuation |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |