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)

JRCT ID: jRCT2031220432

Registered date:04/11/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Narcolepsy
• Date of first enrollment: 09/11/2022
• Target sample size: 123
• Study type: Interventional
• Intervention(s): BF2.649 tablets(10 mg or 20 mg or 40 mg) or placebo tablets

Outcome(s)

• Primary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: < 65age old
• Gender: Both

Include 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

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

Related Information

• Primary Sponsor: Uchimura Naohisa