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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)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031220501
Enrollment
98
Registered
2022-12-09
Start date
2023-01-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obstructive sleep apnea syndrome

Interventions

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

Sponsors

Uchimura Naohisa
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - 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)

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

MeasureTime frame
Epworth Sleepiness Scale (ESS)—

Contacts

Public ContactChihiro Ono

CMIC Co., Ltd.

ClinicalTrialInformation@cmic.co.jp+81-80-8700-5366

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026