Phase
Condition
Headaches
Pain (Pediatric)
Oral Facial Pain
Treatment
Placebo
Rimegepant 75 MG
Rimegepant 25 MG
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, including the following:
Migraine attacks present for more than 1 year with the age of onset prior to 50years of age.
Migraine attacks, on average, lasting about 4-72 hours if untreated.
Not more than 8 attacks of moderate to severe intensity per month within the last 3months.
Ability to distinguish migraine attacks from tension/cluster headaches.
Consistent migraine headaches of at least 2 migraine headache attacks of moderate orsevere intensity in each of the 3 months prior to Screening Visit and maintains thisrequirement during the Screening period.
Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to Screening Visit and maintains this requirement during theScreening Period.
Subjects on prophylactic migraine medication are permitted to remain on therapy ifthe dose has been stable for at least 3 months prior to the Screening Visit, and ifthe dose is not expected to change during the course of the study.
Subjects with contraindications for use of triptans may be included provided theymeet all other study entry criteria.
Exclusion
Exclusion Criteria:
Subject has a history of migraine with brainstem aura (basilar migraine), hemiplegicmigraine or retinal migraine.
History of use of analgesics (e.g. nonsteroidal anti-inflammatory drugs [NSAIDs] oracetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to theScreening Visit.
Subject history with current evidence of uncontrolled, unstable or recentlydiagnosed cardiovascular disease, such as ischemic heart disease, coronary arteryvasospasm, and cerebral ischemia. Subjects with Myocardial Infarction (MI), AcuteCoronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery,stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
Uncontrolled hypertension or uncontrolled diabetes (however subjects can be includedwho have stable hypertension and/or diabetes for at least 3 months prior toscreening).
Subject with other pain syndromes, psychiatric conditions, dementia, or significantneurological disorders (other than migraine) that, in the Investigator's opinion,interfere with study assessments.
Subject has a history of gastric, or small intestinal surgery (including GastricBypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has a diseasethat causes malabsorption.
The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspectedinfection, hepatitis B or C, or cancer) that, in the investigator's opinion, wouldexpose them to undue risk of a significant adverse event (AE) or interfere withassessments of safety or efficacy during the course of the trial.
History of alcohol abuse and/or illicit drug use meeting DSM-V criteria forsubstance use disorder within 6 months of screening.
Participation in any other investigational clinical trial while participating inthis clinical trial.
Study Design
Connect with a study center
Tdc Ichikawa General Hospital
Ichikawa-shi, Chiba 272-8513
JapanSite Not Available
Tokyo Dental College Ichikawa General Hospital
Ichikawa-shi, Chiba 272-8513
JapanSite Not Available
Medical Corporation Seikokai Takanoko Hospital
Matsuyama-shi, Ehime 790-0925
JapanSite Not Available
Ikeda Neurosurgical Clinic
Kasuga-shi, Fukuoka 816-0824
JapanSite Not Available
Jinnouchi Neurosurgical Clinic
Kasuga-shi, Fukuoka 816-0802
JapanSite Not Available
Ota Memorial Hospital
Ota-shi, Gunma 373-8585
JapanSite Not Available
SUBARU Health Insurance Society Ota Memorial Hospital
Ota-shi, Gunma 373-8585
JapanSite Not Available
DOI CL Intern. Med./Neurol.
Hiroshima-shi, Hiroshima 730-0031
JapanSite Not Available
DOI CLINIC Internal Medicine/Neurology
Hiroshima-shi, Hiroshima 730-0031
JapanSite Not Available
Japanese Red Cross Asahikawa Hospital
Asahikawa-shi, Hokkaido 070-8530
JapanSite Not Available
Nakamura Memorial Hospital
Sapporo shi, Hokkaido 060-8570
JapanSite Not Available
Higashi Sapporo Neurology and Neurosurgery Clinic
Sapporo-shi, Hokkaido 003-0003
JapanSite Not Available
Nakamura Memorial Hospital
Sapporo-shi, Hokkaido 060-8570
JapanSite Not Available
Konan Medical Center
Kobe shi, Hyogo 658-0064
JapanSite Not Available
Nishinomiya Municipal Central Hospital
Nishinomiya-shi, Hyogo 663-8014
JapanSite Not Available
Konan Medical Center
Kobe-shi, Hyōgo 658-0064
JapanSite Not Available
Mito Kyodo General Hospital
Mito-shi, Ibaraki 310-0015
JapanSite Not Available
Kijima Neurosurgery Clinic
Kahoku-gun, Ishikawa 929-0342
JapanSite Not Available
Iwate Med. Univ. Uchimaru MC
Morioka-shi, Iwate 020-8505
JapanSite Not Available
Iwate Medical University Uchimaru Medical Center
Morioka-shi, Iwate 020-8505
JapanSite Not Available
Atsuchi Neurosurgery Hospital
Kagoshima-shi, Kagoshima 892-0842
JapanSite Not Available
Tanaka Neurosurgical Clinic
Kagoshima-shi, Kagoshima 892-0844
JapanSite Not Available
Tanaka neurosurgical clinic
Kagoshima-shi, Kagoshima 892-0844
JapanActive - Recruiting
Fujitsu Clinic
Kawasaki-shi, Kanagawa 211-8588
JapanSite Not Available
St. Marianna Univ. Hospital
Kawasaki-shi, Kanagawa 216-8511
JapanSite Not Available
St. Marianna University Hospital
Kawasaki-shi, Kanagawa 216-8511
JapanSite Not Available
Fujitsu Clinic
Nakahara, Kanagawa 211-8588
JapanSite Not Available
Fujitsu Clinic
Nakahara, Kawasaki, Kanagawa 211-8588
JapanSite Not Available
Saiseikai Kumamoto Hospital
Kumamoto-shi, Kumamoto 861- 4193
JapanSite Not Available
Saisekai Kumamot Hospital
Kumamoto-shi, Kumamoto 861-4193
JapanSite Not Available
Kyoto Okamoto Memorial Hospital
Kumiyama-cho, Kyoto 613-0034
JapanSite Not Available
Kyoto Okamoto Memorial Hospital
Kumiyama-cho, Kuse-gun, Kyoto 613-0034
JapanSite Not Available
Tatsuoka Neurology Clinic
Kyoto-shi, Kyoto 600-8811
JapanSite Not Available
University Hospital Kyoto Prefectural University of Medicine
Kyoto-shi, Kyoto 602-8566
JapanSite Not Available
Ishikawa Clinic
Sakyo-ku, Kyoto 606-0851
JapanSite Not Available
Ishikawa Clinic
Sakyo-ku, Kyoto-city, Kyoto 606-0851
JapanSite Not Available
Tatsuoka Neurology Clinic
Shimogyo-ku, Kyoto 600-8811
JapanSite Not Available
Tatsuoka Neurology Clinic
Shimogyo-ku, Kyoto, Kyoto 600-8811
JapanSite Not Available
Atago Hospital
Kochi-shi, Kōchi 780-0051
JapanSite Not Available
Umenotsuji Clinic
Kochi-shi, Kōchi 780-8011
JapanSite Not Available
Narikawa Neurological Clinic
Izumi-ku, Miyagi 981-3126
JapanSite Not Available
Narikawa Neurological Clinic
Izumi-ku, Sendai-city, Miyagi 981-3126
JapanSite Not Available
Sendai Headache and Neurology Clinic, Medical Corporation
Sendai-shi, Miyagi 982-0014
JapanSite Not Available
Medical corporation oblige Ooba Clinic for Neurosurgery & Headache
Oita-shi, Oita 870-0831
JapanSite Not Available
Ooba CL Neurosurg. & Headache
Oita-shi, Oita 870-0831
JapanSite Not Available
Makabe Clinic
Okayama-shi, Okayama 700-0964
JapanSite Not Available
Okayama City General Medical Center Okayama City Hospital
Okayama-shi, Okayama 700-8557
JapanSite Not Available
Tominaga Clinic
Naniwa-ku, Osaka 556-0015
JapanSite Not Available
Tominaga Clinic
Naniwa-ku, Osaka-shi, Osaka 556-0015
JapanSite Not Available
Kitano Hospital,Tazuke Kofukai Medical Research Institute
Osaka-city, Osaka 530-8480
JapanActive - Recruiting
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai
Osaka-city, Osaka 530-8480
JapanSite Not Available
Kitano Hospital,Tazuke Kofukai Medical Research Institute
Osaka-shi, Osaka 530-8480
JapanSite Not Available
Tominaga Clinic
Osaka-shi, Osaka 556-0015
JapanSite Not Available
Kindai University Hospital
Osakasayama-shi, Osaka 589-8511
JapanSite Not Available
Takase Intern. Med. Clinic
Toyonaka-shi, Osaka 560-0012
JapanSite Not Available
Takase Internal Medicine Clinic
Toyonaka-shi, Oska 560-0012
JapanSite Not Available
Saitama Medical University Hospital
Iruma-gun, Saitama 350-0495
JapanSite Not Available
Saitama Neuropsychiatric Institute
Saitama-shi, Saitama 338-8577
JapanSite Not Available
JRC Shizuoka Hospital
Shizuoka-shi, Shizuoka 420-0853
JapanSite Not Available
Japanese Red Cross Shizuoka Hospital
Shizuoka-shi, Shizuoka 420-0853
JapanSite Not Available
Dokkyo Medical Univ. Hosp.
Shimotsuga-gun, Tochigi 321-0293
JapanSite Not Available
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi 321-0293
JapanSite Not Available
Juntendo University Hospital
Bunkyo-ku, Tokyo 113-8431
JapanSite Not Available
Juntendo University Hospital
Bunkyō-Ku, Tokyo 113-8431
JapanSite Not Available
Tokai university hachioji hospital
Hachioji-shi, Tokyo 192-0032
JapanSite Not Available
Kitasato University Kitasato Institute Hospital
Minato-Ku, Tokyo 108-8642
JapanActive - Recruiting
Shinagawa Strings Clinic
Minato-Ku, Tokyo 108-0075
JapanActive - Recruiting
Kitasato Institute Hospital
Minato-ku, Tokyo 108-8642
JapanSite Not Available
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo 108-8642
JapanSite Not Available
Shinagawa Strings Clinic
Minato-ku, Tokyo 108-0075
JapanSite Not Available
USUDA CLINIC for internal medicine
Setagaya-Ku, Tokyo 156-0043
JapanActive - Recruiting
USUDA CLINIC for internal medicine
Setagaya-ku, Tokyo 156-0043
JapanSite Not Available
Tokyo Headache Clinic
Shibuya-Ku, Tokyo 151-0051
JapanSite Not Available
Fukuuchi Pain Clinic
Shinjuku-Ku, Tokyo 160-0017
JapanActive - Recruiting
Keio University Hospital
Shinjuku-Ku, Tokyo 160-8582
JapanActive - Recruiting
Fukuuchi Pain Clinic
Shinjuku-ku, Tokyo 160-0017
JapanSite Not Available
Keio University Hospital
Shinjuku-ku, Tokyo 160-8582
JapanSite Not Available
Nishiogi Pain Clinic
Suginami-Ku, Tokyo 167-0054
JapanActive - Recruiting
Nishiogi Pain Clinic
Suginami-ku, Tokyo 167-0054
JapanSite Not Available
Suzuki Kei Yasuragi clinic
Tachikawa-city, Tokyo 190-0001
JapanSite Not Available
Sakura Clinic
Toyama-shi, Toyama 930-0803
JapanSite Not Available
Sakura Neuro Clinic
Toyama-shi, Toyama 930-0803
JapanSite Not Available
Nagamitsu Clinic
Hofu-shi, Yamaguchi 747-0802
JapanSite Not Available
Nagaseki Headache Clinic
Kai-shi, Yamanashi 400-0124
JapanSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.