好色先生

好色先生

Explore the latest content from across our publications
Join The AAN

Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

Efficacy and Safety of Rimegepant for the Prevention of Migraine in Japan
Headache
P8 - Poster Session 8 (8:00 AM-9:00 AM)
12-007
The primary objective was to compare the efficacy of rimegepant (RIM) with placebo (PBO) for the preventive treatment of migraine in participants living in Japan.
This phase 3 trial (NCT05399485) was a double-blind (DB), randomized, multicenter evaluation of the efficacy and safety of RIM orally disintegrating tablet compared with PBO for the preventive treatment of migraine in participants living in Japan.
Adults with a history of 4–18 migraine attacks/month of moderate or severe pain intensity completed a 28-day observation phase (OP), then took RIM 75 mg or PBO every other day (EOD) during the 12-week DB phase, followed by RIM 75 mg EOD and up to once daily as needed on nonscheduled dosing days during the 40-week open-label phase. Hierarchical testing was used for efficacy and outcomes research endpoints to control for multiplicity. The primary endpoint was mean change from OP in the number of monthly migraine days (MMDs) in the last 4 weeks of the DB phase. Safety was assessed based on adverse events (AEs) and laboratory test abnormalities. Data are presented for the DB phase.
A total of 484 (efficacy) and 496 (safety) treated participants were evaluable. During the OP, participants reported a mean ± SD of 9.3 ± 3.08 (RIM) and 9.0 ± 3.14 (PBO) MMDs. The study met its primary endpoint with a statistically significant difference in mean change from OP in the number of MMDs in the last 4 weeks of the DB phase for RIM vs PBO (difference –1.1 [95% CI –1.73, –0.38], p=0.0021). Results for secondary efficacy endpoints numerically favored RIM vs PBO. RIM was well tolerated during the DB phase. There were no Hy’s law cases.

RIM 75 mg EOD demonstrated efficacy superior to PBO for migraine prevention with a favorable safety profile. Funded by Pfizer.
Authors/Disclosures
Robert Fountaine
PRESENTER 		Robert Fountaine has received personal compensation for serving as an employee of Pfizer, Inc.. Robert Fountaine has or had stock in Pfizer, Inc.Robert Fountaine has or had stock in Viatris, Inc.
Yasuhiko Matsumori, Jr., MD, PhD Dr. Matsumori has nothing to disclose.
Shige Kitamura, MD Dr. ?? has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. ?? has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Otsuka. Dr. ?? has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Daiichi-Sankyo. Dr. ?? has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eli Lilly. Dr. ?? has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen.
Toshimasa Yamamoto, MD, PhD Dr. Yamamoto has nothing to disclose.
Tomofumi Ishikawa, PhD Dr. Ishikawa has received personal compensation for serving as an employee of Pfizer. Dr. Ishikawa has stock in Pfizer.
Yuko Hoshino, PhD Dr. Hoshino has received personal compensation for serving as an employee of Pfizer.
Hiroki Yoshimatsu, PhD Dr. Yoshimatsu has received personal compensation for serving as an employee of Pfizer R&D Japan.
Alexandra Thiry, PhD Dr. Thiry has received personal compensation for serving as an employee of Pfizer. Dr. Thiry has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. Dr. Thiry has stock in Pfizer. Dr. Thiry has stock in Biohaven Pharmaceuticals.
Akio Arakawa, PhD Dr. Arakawa has received personal compensation for serving as an employee of Pfizer. Dr. Arakawa has stock in Pfizer.
Robert Croop, MD Dr. Croop has received personal compensation for serving as an employee of Biohaven Pharmaceuticals, Inc. Dr. Croop has received personal compensation for serving as an employee of Pfizer Inc.. Dr. Croop has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Collima LLC. Dr. Croop has stock in Biohaven Pharmaceutical Holding Co Ltd. Dr. Croop has stock in Biohaven Ltd.. Dr. Croop has stock in Actio Biosciences, Inc. . Dr. Croop has received research support from Pfizer Inc. Dr. Croop has received intellectual property interests from a discovery or technology relating to health care. Dr. Croop has received intellectual property interests from a discovery or technology relating to health care.
Terence Fullerton, PharmD (Pfizer Global Product Development) Dr. Fullerton has received personal compensation for serving as an employee of Pfizer. Dr. Fullerton has stock in Pfizer.
Fumihiko Sakai, MD Dr. Sakai has nothing to disclose.
TAKAO Takeshima Dr. Takeshima has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sawai. Dr. Takeshima has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teijin. Dr. Takeshima has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Hedgcock MedTech. Dr. Takeshima has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Otsuka. Dr. Takeshima has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Takeshima has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Elli-Lilly Japan. The institution of Dr. Takeshima has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Daiichi-Sankyo.