Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01620554
• Date of registration: 08/06/2012
• Prospective Registration: No
• Primary sponsor: Bioprojet
• Public title: Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA)
• Scientific title: Minimum Effective Dose-Finding Study of BF2.649, in Patients With Moderate to Severe OSA, Experiencing EDS Despite Regular Use of nCPAP, and Patients Having Refused This Therapy - Randomized, Double Blind Study With BF2.649 or Placebo
• Date of first enrolment: October 2010
• Target sample size: 110
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01620554
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Evelyne De Paillette, MD
• Affiliation: Bioprojet

Key inclusion & exclusion criteria

Main inclusion Criteria:

- Patient with OSA (treated or not with nCPAP) and still complaining of EDS

- Epworth Sleepiness Scale score > or = to 11

Main exclusion Criteria:

- Patient suffering from chronic severe insomnia in accordance with the International
Classification of Sleep Disorders, but without OSA



Age minimum: 21 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Obstructive Sleep Apnoea

Excessive Daytime Sleepiness

Intervention(s)

Drug: BF2.649

Drug: Placebo

Primary Outcome(s)

Change in Epworth Sleepiness Scale scores (ESS) [Time Frame: change of ESS at 2 weeks]

Secondary ID(s)

2010-019413-25

P09-16 / BF2.649

Source(s) of Monetary Support

Please refer to primary and secondary sponsors