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Phase 3 Study to Evaluate the Efficacy and Safety of Orally Administered BF2.649 in Japanese Patients with Obstructive Sleep Apnea Syndrome Complaining Excessive Daytime Sleepiness despite Treated by Nasal Continuous Positive Airway Pressure (nCPAP), Consisting of a Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study (Part 1) and Subsequent Open-label Extension Study (Part 2)

Phase 3 Study to Evaluate the Efficacy and Safety of Orally Administered BF2.649 in Japanese Patients with Obstructive Sleep Apnea Syndrome Complaining Excessive Daytime Sleepiness despite Treated by Nasal Continuous Positive Airway Pressure (nCPAP), Consisting of a Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study (Part 1) and Subsequent Open-label Extension Study (Part 2)

Uchimura Naohisa

Kurume University Hospital

1-1-1, Shibaura, Minato-ku, Tokyo

PM_PitolisantP1_PM@cmic.co.jp

Ono Chihiro

CMIC Co., Ltd.

1-1-1, Shibaura, Minato-ku, Tokyo

+81-80-8700-5366

ClinicalTrialInformation@cmic.co.jp

Recruiting

Dec. 12, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Individuals who have been diagnosed with obstructive sleep apnea syndrome
- Japanese males or females aged 18 years or older at the time of informed consent
- Individuals whose daytime sleepiness have not been improved even after 3 months of nCPAP therapy.
- Individuals who can continue to use nCPAP during the study.
- In the past 1 month, percentage of days wearing nCPAP is at least 70%, and mean wearing time of days wearing is at least 4 hours/day.
- ESS score is at least 12 (mean score of baseline period and Day 0)

- Individuals who have been confirmed to have a comorbidity/complication other than obstructive sleep apnea syndrome (severe insomnia, narcolepsy, restless legs syndrome, idiopathic hypersomnia, recurrent hypersomnia, periodic limb movement disorder, circadian rhythm sleep disorder, parasomnia, insufficient sleep time, etc.) by previously conducted polysomnography (PSG) test etc.
-Individuals who need to engage in irregular shift work or nighttime work.
-Individuals with a disease that may affect the evaluation of study, such as severe COPD.

Both

obstructive sleep apnea syndrome

BF2.649 oral administration at a dose of 5mg or 10mg or 20 mg, or placebo tablets

Epworth Sleepiness Scale (ESS)

+81-45-722-8655

Oct. 27, 2022

No

none