Phase
Condition
Migraine (Adult)
Pain
Oral Facial Pain
Treatment
Placebo
Rimegepant
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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:
Age of onset of migraines prior to 50 years of age.
Migraine attacks, on average, lasting 4 to 72 hours if untreated.
Per subject report, 4 to18 migraine attacks of moderate or severe intensity permonth within the last 3 months prior to the Screening Visit (month is defined as 4weeks for the purpose of this protocol).
4 or more migraine days during Observation Period.
Not more than 18 headache days during the Observation Period.
Ability to distinguish migraine attacks from tension/cluster headaches.
Subjects on prophylactic migraine medication are permitted to remain on therapy ifthe dose has been stable for at least 3 months (12 weeks) prior to the ObservationPeriod, and the 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.
Subjects with headaches occurring 19 or more days per month (migraine ornon-migraine) in any of the 3 months prior to the Screening Visit.
History of systemic 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.
Subject with a history of HIV disease.
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 beincluded who have stable hypertension and/or diabetes for 3 months prior toscreening).
Subject with other pain syndromes, psychiatric conditions, dementia, or significantneurological disorders (other than migraine) that, in the Investigator's opinion,might 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 disease thatcauses 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, treatment for, or evidence of, alcohol or drug abuse within the past 12months or subjects who have met DSM-V criteria for any significant substance usedisorder within the past 12 months from the date of the screening visit.
Participation in any other investigational clinical trial while participating inthis clinical trial.
Study Design
Connect with a study center
Medical Corporation Seikokai Takanoko Hospital
Matsuyama-shi, Ehime 790-0925
JapanSite Not Available
Medical Corporation Seikokai Takanoko Hospital
Matsuyama 1926099, Ehime 1864226 790-0925
JapanSite Not Available
Ikeda Neurosurgical Clinic
Kasuga-shi, Fukuoka 1863958 816-0824
JapanSite Not Available
Jinnouchi Neurosurgical Clinic
Kasuga-shi, Fukuoka 1863958 816-0802
JapanSite Not Available
SUBARU Health Insurance Society Ota Memorial Hospital
Ota-shi, Gunma 1863501 373-8585
JapanSite Not Available
DOI CLINIC Internal Medicine/Neurology
Hiroshima-shi, Hiroshima 730-0031
JapanSite Not Available
Doi Clinic Internal Medicine/Neurology
Hiroshima-shi, Hiroshima 730-0031
JapanActive - Recruiting
Doi Clinic Internal Medicine/Neurology
Hiroshima 1862415, Hiroshima 1862413 730-0031
JapanSite Not Available
Nakamura Memorial Hospital
Chuo-ku, Hokkaido 060-8570
JapanSite Not Available
Nakamura Memorial Hospital
Chuo-ku, Sapporo-shi, Hokkaido 060-8570
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
Higashi Sapporo Neuro. CL
Shiroishi, Sapporo, Hokkaido 003-0003
JapanSite Not Available
Japanese Red Cross Asahikawa Hospital
Asahikawa-shi, Hokkaido 2130037 070-8530
JapanSite Not Available
Nakamura Memorial Hospital
Chūōku 11828195, Hokkaido 2130037 060-8570
JapanSite Not Available
Higashi Sapporo Neurology and Neurosurgery Clinic
Sapporo 2128295, Hokkaido 2130037 003-0003
JapanSite Not Available
Konan Medical Center
Kobe shi, Hyogo 658-0064
JapanSite Not Available
Konan Medical Center
Higashinada-ku, Kobe, Hyōgo 658-0064
JapanSite Not Available
Konan Medical Center
Higashinada-ku, Hyōgo 1862047 658-0064
JapanSite Not Available
Nishinomiya Munic. Ctr. Hosp.
Nishinomiya-shi, Hyōgo 1862047 663-8014
JapanSite Not Available
Mito Kyodo General Hospital
Mito-shi, Ibaraki 310-0015
JapanSite Not Available
Mito Kyodo General Hospital
Mito 2111901, Ibaraki 2112669 310-0015
JapanSite Not Available
Kijima Neurosurgery Clinic
Kahoku-gun, Ishikawa-ken 1861387 929-0342
JapanSite Not Available
Iwate Medical University Uchimaru Medical Center
Morioka-shi, Iwate 020-8505
JapanSite Not Available
Iwate Medical University Uchimaru Medical Center
Morioka 2111834, Iwate 2112518 020-8505
JapanSite Not Available
Atsuchi Neurosurgery Hospital
Kagoshima-shi, Kagoshima 892-0842
JapanSite Not Available
Tanaka Neurosurgical Clinic
Kagoshima-shi, Kagoshima 892-0844
JapanActive - Recruiting
Tanaka neurosurgical clinic
Kagoshima-shi, Kagoshima 892-0844
JapanSite Not Available
Atsuchi Neurosurgery Hospital
Kagoshima 1860827, Kagoshima-ken 1860825 892-0842
JapanSite Not Available
Tanaka Neurosurgical Clinic
Kagoshima 1860827, Kagoshima-ken 1860825 892-0844
JapanSite Not Available
Fujitsu Clinic
Nakahara, Kanagawa 211-8588
JapanSite Not Available
Fujitsu Clinic
Nakahara, Kawasaki, Kanagawa 211-8588
JapanSite Not Available
St. Marianna Univ. Hospital
Kawasaki-shi, Kanagawa 1860291 216-8511
JapanSite Not Available
Fujitsu Clinic
Nakahara 10419977, Kanagawa 1860291 211-8588
JapanSite Not Available
Atago Hospital
Kochi 1859146, Kochi 1859133 780-0051
JapanSite Not Available
Umenotsuji Clinic
Kochi 1859146, Kochi 1859133 780-8011
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
Saiseikai Kumamoto Hospital
Kumamoto 1858421, Kumamoto 1858419 861- 4193
JapanSite Not Available
Tatsuoka Neurology Clinic
Kyoto-shi, Kyoto 600-8811
JapanSite Not Available
Tatsuoka Neurology Clinic
Kyoto 1857910, Kyoto 1857907 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
Sendai Headache and Neurology Clinic, Medical Corporation
Sendai-shi, Miyagi 982-0014
JapanSite Not Available
Sendai Headache and Neurology Clinic, Medical Corporation
Sendai 2111149, Miyagi 2111888 982-0014
JapanSite Not Available
Medical corporation oblige Ooba Clinic for Neurosurgery & Headache
Oita-shi, Oita 870-0831
JapanSite Not Available
Ooba Clinic for Neurosurgery & Headache
Oita-shi, Oita 870-0831
JapanSite Not Available
Ooba Clinic for Neurosurgery & Headache
Ōita 1854487, Oita Prefecture 1854484 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
Makabe Clinic
Okayama 1854383, Okayama-ken 1854381 700-0964
JapanSite Not Available
Okayama City General Medical Center Okayama City Hospital
Okayama 1854383, Okayama-ken 1854381 700-8557
JapanSite Not Available
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai
Osaka-city, Osaka 530-8480
JapanSite Not Available
Kitano Hospital Tazuke Kofukai
Osaka-shi, 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
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai
Osaka 1853909, Osaka 1853904 530-8480
JapanSite Not Available
Tominaga Clinic
Osaka 1853909, Osaka 1853904 556-0015
JapanSite Not Available
Kindai University Hospital
Osakasayama-shi, Osaka 1853904 589-8511
JapanSite Not Available
Takase Intern. Med. Clinic
Toyonaka-shi, Osaka 1853904 560-0012
JapanSite Not Available
Saitama Medical University Hospital
Iruma-gun, Saitama 1853226 350-0495
JapanSite Not Available
Saitama Neuropsychiatric Institute
Saitama-shi, Saitama 1853226 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
Japanese Red Cross Shizuoka Hospital
Shizuoka 1851717, Shizuoka 1851715 420-0853
JapanSite Not Available
Dokkyo Medical University Hospital
Shimosuga, Tochigi 321-0293
JapanSite Not Available
Dokkyo Medical Univ. Hosp.
Shimotsuga-gun, Tochigi 1850310 321-0293
JapanSite Not Available
Juntendo University Hospital
Bunkyō-Ku, Tokyo 113-8431
JapanSite Not Available
Juntendo University Hospital
Bunkyo-ku, Tokyo 1850144 113-8431
JapanSite Not Available
Tokai univ. hachioji hosp.
Hachioji-shi, Tokyo 1850144 192-0032
JapanSite Not Available
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo 1850144 108-8642
JapanSite Not Available
Shinagawa Strings Clinic
Minato-ku, Tokyo 1850144 108-0075
JapanSite Not Available
USUDA CLINIC for internal medicine
Setagaya-ku, Tokyo 1850144 156-0043
JapanSite Not Available
Fukuuchi Pain Clinic
Shinjuku-ku, Tokyo 1850144 160-0017
JapanSite Not Available
Keio University Hospital
Shinjuku-ku, Tokyo 1850144 160-8582
JapanSite Not Available
Nishiogi Pain Clinic
Suginami-ku, Tokyo 1850144 167-0054
JapanSite Not Available
Sakura Clinic
Toyama-shi, Toyama 930-0803
JapanSite Not Available
Sakura Neuro Clinic
Toyama-shi, Toyama 930-0803
JapanSite Not Available
Sakura Neuro Clinic
Toyama 1849876, Toyama 1849872 930-0803
JapanSite Not Available
Nagamitsu Clinic
Hofu-shi, Yamaguchi 1848681 747-0802
JapanSite Not Available
Nagaseki Headache Clinic
Kai-shi, Yamanashi 1848649 400-0124
JapanSite Not Available

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