Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)
Launched by PFIZER · May 27, 2022
Trial Information
Current as of May 01, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- Subject has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
- • 1. Age of onset of migraines prior to 50 years of age
- • 2. Migraine attacks, on average, lasting 4 to 72 hours if untreated
- • 3. Per subject report, 4 to18 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol)
- • 4. 4 or more migraine days during Observation Period
- • 5. Not more than 18 headache days during the Observation Period
- • 6. Ability to distinguish migraine attacks from tension/cluster headaches
- • 7. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Observation Period, and the dose is not expected to change during the course of the study.
- • 8. Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria
- Exclusion Criteria:
- • 1. Subject has a history of migraine with brainstem aura (basilar migraine) or hemiplegic migraine
- • 2. Subjects with headaches occurring 19 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit.
- • 3. History of use of analgesics (e.g. nonsteroidal anti-inflammatory drugs \[NSAIDs\] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
- • 4. Subject with a history of HIV disease
- • 5. Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS),Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening
- • 6. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled)
- • 7. Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments.
- • 8. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption
- • 9. The subject has a history of current or evidence of any significant and/ or unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.
- • 10. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.
- • 11. Participation in any other investigational clinical trial while participating in this clinical trial
About Pfizer
Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shinjuku Ku, Tokyo, Japan
Bunkyo Ku, Tokyo, Japan
Shimotsuga Gun, Tochigi, Japan
Minato Ku, Tokyo, Japan
Kumamoto Shi, Kumamoto, Japan
Iruma Gun, Saitama, Japan
Shinjuku Ku, Tokyo, Japan
Osakasayama Shi, Osaka, Japan
Kyoto Shi, Kyoto, Japan
Saitama Shi, Saitama, Japan
Hofu Shi, Yamaguchi, Japan
Kai Shi, Yamanashi, Japan
Ota Shi, Gunma, Japan
Morioka Shi, Iwate, Japan
Okayama Shi, Okayama, Japan
Setagaya Ku, Tokyo, Japan
Shizuoka Shi, Shizuoka, Japan
Minato Ku, Tokyo, Japan
Bunkyō Ku, Tokyo, Japan
Mito Shi, Ibaraki, Japan
Kawasaki Shi, Kanagawa, Japan
Kumamoto Shi, Kumamoto, Japan
Matsuyama Shi, Ehime, Japan
Kasuga Shi, Fukuoka, Japan
Kasuga Shi, Fukuoka, Japan
Ota Shi, Gunma, Japan
Hiroshima Shi, Hiroshima, Japan
Asahikawa Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Kobe Shi, Hyogo, Japan
Nishinomiya Shi, Hyogo, Japan
Kahoku Gun, Ishikawa, Japan
Kagoshima Shi, Kagoshima, Japan
Kagoshima Shi, Kagoshima, Japan
Kawasaki Shi, Kanagawa, Japan
Kochi Shi, Kochi, Japan
Kochi Shi, Kochi, Japan
Sendai Shi, Miyagi, Japan
Oita Shi, Oita, Japan
Okayama Shi, Okayama, Japan
Osaka Shi, Osaka, Japan
Osaka Shi, Osaka, Japan
Toyonaka Shi, Oska, Japan
Hachioji Shi, Tokyo, Japan
Suginami Ku, Tokyo, Japan
Toyama Shi, Toyama, Japan
Ota Shi, Gunma, Japan
Oita Shi, Oita, Japan
Shimosuga, Tochigi, Japan
Kawasaki Shi, Kanagawa, Japan
Nakahara, Kawasaki, Kanagawa, Japan
Kumamoto Shi, Kumamoto, Japan
Kochi Shi, Kōchi, Japan
Kochi Shi, Kōchi, Japan
Toyonaka Shi, Osaka, Japan
Shizuoka Shi, Shizuoka, Japan
Chuo Ku, Sapporo Shi, Hokkaido, Japan
Higashinada Ku, Kobe, Hyōgo, Japan
Nishinomiya Shi, Hyōgo, Japan
Osaka Shi, Osaka, Japan
Shimotsuga Gun, Tochigi, Japan
Shiroishi, Sapporo, Hokkaido, Japan
Hachioji Shi, Tokyo, Japan
Toyama Shi, Toyama, Japan
Osaka City, Osaka, Japan
Chuo Ku, Hokkaido, Japan
Higashinada Ku, Hyōgo, Japan
Nakahara, Kanagawa, Japan
Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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