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Phase 3 Study to Evaluate the Efficacy and Safety of Orally Administered BF2.649 in Japanese Patients with Narcolepsy, 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 Narcolepsy, 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-jRCT2031220432
Enrollment
123
Registered
2022-11-04
Start date
2022-11-09
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

Narcolepsy

Interventions

BF2.649 tablets(10 mg or 20 mg or 40 mg) or placebo tablets

Sponsors

Uchimura Naohisa
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Japanese males and females aged 15 or older and less than 65 - Individuals who have been diagnosed with narcolepsy (type 1 or type 2) - ESS score is at least 14

Exclusion criteria

Exclusion criteria: Apnea hypopnea index (AHI) is 15 or above, or Periodic limb movement arousal index (PLMAI) is 10 or above.

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of oral administration of BF2.649 for 8 weeks on the improvement of excessive daytime sleepiness by comparing Epworth Sleepiness Scale (ESS) with placebo in patients with narcolepsy.—

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