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Search / Trial NCT05399485

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

Migraine Headache Migraine Prevention

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.

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

0 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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