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Nov. 04, 2022

April. 07, 2023

jRCT2031220432

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)

Uchimura Naohisa

Kurume University Hospital

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

+81-80-8700-5366

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

Nov. 01, 2022

Nov. 09, 2022
123

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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

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

15age old over
65age old not

Both

Narcolepsy

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

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.

Aculys Pharma, Inc.
Kobori Central Clinical Research Ethics Committee
5-11-8, Nishi-nippori, Arakawa-ku, Tokyo

+81-3-6779-8166

Approval

No

none

History of Changes

No Publication date
2 April. 07, 2023 (this page) Changes
1 Nov. 04, 2022 Detail