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)
Active, not recruiting
- Conditions
- Narcolepsy
- Registration Number
- jRCT2031220432
- Lead Sponsor
- Aculys Pharma, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 123
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
Apnea hypopnea index (AHI) is 15 or above, or Periodic limb movement arousal index (PLMAI) is 10 or above.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method Epworth Sleepiness Scale (ESS) 8 weeks 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.
- Secondary Outcome Measures
Name Time Method