Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)
- Conditions
- Migraine
- Interventions
- Registration Number
- NCT05399459
- Lead Sponsor
- Pfizer
- Brief Summary
This study is being conducted to determine the appropriate dose of rimegepant in Japanese subjects, as well as to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the acute treatment of migraine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 803
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 50 years 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 3 months
- Ability to distinguish migraine attacks from tension/cluster headaches
- Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening period
- Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period.
- Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months prior to the Screening Visit, and if the dose is not expected to change during the course of the study.
- Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria
- Subject has a history of migraine with brainstem aura (basilar migraine) or hemiplegic migraine
- 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.
- Subject with a history of HIV disease
- 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
- 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)
- Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological 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 Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption
- 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.
- 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.
- Participation in any other investigational clinical trial while participating in this clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rimegepant 25 mg Rimegepant 25 MG Single dose of 25 mg orally disintegrating tablet of rimegepant Rimegepant 75 mg Rimegepant 75 MG Single dose of 75 mg orally disintegrating tablet of rimegepant Placebo Placebo Matching placebo tablet
- Primary Outcome Measures
Name Time Method Pain freedom at 2 hours post-dose 2 hours post-dose Measured by the number of subjects that report no pain. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
- Secondary Outcome Measures
Name Time Method Sustained pain relief from 2 to 48 hours post-dose From 2 hours up to 48 hours post-dose Measured by the number of subjects that do not use any rescue medications, and do not experience any moderate or severe headache pain through the time period of interest.
Sustained pain freedom from 2 to 24 hours post-dose From 2 hours up to 24 hours post-dose Measured by the number of subjects that do not use any rescue medications, and do not experience any headache pain through the time period of interest
Freedom from nausea at 2 hours post-dose Baseline, 2 hours post-dose Measured by tabulating the number of subjects that report the absence of nausea at 2 hours post-dose in the subset of subjects that reported the presence of nausea at headache baseline
Freedom from the Most Bothersome Symptom (MBS) associated with migraine at 2 hours post-dose. 2 hours post-dose Measured by the number of subjects that report the absence of their MBS at 2 hours post-dose. The MBS (nausea, phonophobia or photophobia) will be measured using a binary scale (0=absent, 1=present)
Ability to function normally at 2 hours post-dose 2 hours post-dose Measured by the number of subjects that self-report as "normal" on the Functional Disability scale. The Functional Disability scale is a four-point scale: normal, mildly impaired, severely impaired, requires bedrest.
Frequency of use of rescue medication within 24 hours of initial treatment. 24 hours post-dose Measured by the number of subjects that take rescue medication within 24 after administration of study medication
Freedom from phonophobia at 2 hours post-dose Baseline, 2 hours post-dose Measured by tabulating the number of subjects that report the absence of phonophobia at 2 hours post-dose in the subset of subjects that reported the presence of phonophobia at headache baseline
Pain relief at 2 hours post-dose. Baseline, 2 hours post-dose Measured by the number of subjects that report a pain level of moderate or severe at baseline and then report a pain level of none or mild at two hours post-dose
Sustained pain freedom from 2 to 48 hours post-dose. From 2 hours up to 48 hours post-dose Measured by the number of subjects that do not use any rescue medications, and do not experience any headache pain through the time period of interest.
Sustained pain relief from 2 to 24 hours post-dose From 2 hours up to 24 hours post-dose Measured by the number of subjects that do not use any rescue medications, and do not experience any moderate or severe headache pain through the time period of interest.
Incidence of pain relapse from 2 to 48 hours post-dose From 2 hours up to 48 hours post-dose Measured by the number of subjects that are pain free at 2 hours post-dose and then have a headache of any severity (response of 1, 2 or 3 on the 4 point scale) within 48 hours after administration of study medication
Freedom from photophobia at 2 hours post-dose Baseline, 2 hours post-dose Measured by tabulating the number of subjects that report the absence of photophobia at 2 hours post-dose in the subset of subjects that reported the presence of photophobia at headache baseline
Trial Locations
- Locations (64)
Konan Medical Center
🇯🇵Kobe-shi, Hyōgo, Japan
Fujitsu Clinic
🇯🇵Nakahara, Kawasaki, Kanagawa, Japan
Suzuki Kei Yasuragi clinic
🇯🇵Tachikawa-city, Tokyo, Japan
Mito Kyodo General Hospital
🇯🇵Mito-shi, Ibaraki, Japan
Juntendo University Hospital
🇯🇵Bunkyō-Ku, Tokyo, Japan
Kitasato University Kitasato Institute Hospital
🇯🇵Minato-Ku, Tokyo, Japan
Sakura Neuro Clinic
🇯🇵Toyama-shi, Toyama, Japan
Nakamura Memorial Hospital
🇯🇵Sapporo-shi, Hokkaido, Japan
Higashi Sapporo Neurology and Neurosurgery Clinic
🇯🇵Sapporo-shi, Hokkaido, Japan
Iwate Medical University Uchimaru Medical Center
🇯🇵Morioka-shi, Iwate, Japan
St. Marianna University Hospital
🇯🇵Kawasaki-shi, Kanagawa, Japan
Saiseikai Kumamoto Hospital
🇯🇵Kumamoto-shi, Kumamoto, Japan
Ishikawa Clinic
🇯🇵Sakyo-ku, Kyoto-city, Kyoto, Japan
Okayama City General Medical Center Okayama City Hospital
🇯🇵Okayama-shi, Okayama, Japan
Takase Intern. Med. Clinic
🇯🇵Toyonaka-shi, Osaka, Japan
Takase Internal Medicine Clinic
🇯🇵Toyonaka-shi, Oska, Japan
SUBARU Health Insurance Society Ota Memorial Hospital
🇯🇵Ota-shi, Gunma, Japan
Kijima Neurosurgery Clinic
🇯🇵Kahoku-gun, Ishikawa, Japan
Tanaka neurosurgical clinic
🇯🇵Kagoshima-shi, Kagoshima, Japan
Umenotsuji Clinic
🇯🇵Kochi-shi, Kōchi, Japan
Kyoto Okamoto Memorial Hospital
🇯🇵Kumiyama-cho, Kuse-gun, Kyoto, Japan
Tatsuoka Neurology Clinic
🇯🇵Shimogyo-ku, Kyoto, Kyoto, Japan
University Hospital Kyoto Prefectural University of Medicine
🇯🇵Kyoto-shi, Kyoto, Japan
Kindai University Hospital
🇯🇵Osakasayama-shi, Osaka, Japan
Saitama Neuropsychiatric Institute
🇯🇵Saitama-shi, Saitama, Japan
Jinnouchi Neurosurgical Clinic
🇯🇵Kasuga-shi, Fukuoka, Japan
Ikeda Neurosurgical Clinic
🇯🇵Kasuga-shi, Fukuoka, Japan
Japanese Red Cross Asahikawa Hospital
🇯🇵Asahikawa-shi, Hokkaido, Japan
Iwate Med. Univ. Uchimaru MC
🇯🇵Morioka-shi, Iwate, Japan
Atsuchi Neurosurgery Hospital
🇯🇵Kagoshima-shi, Kagoshima, Japan
Atago Hospital
🇯🇵Kochi-shi, Kōchi, Japan
Narikawa Neurological Clinic
🇯🇵Izumi-ku, Sendai-city, Miyagi, Japan
JRC Shizuoka Hospital
🇯🇵Shizuoka-shi, Shizuoka, Japan
Sakura Clinic
🇯🇵Toyama-shi, Toyama, Japan
Kitasato Institute Hospital
🇯🇵Minato-ku, Tokyo, Japan
Fukuuchi Pain Clinic
🇯🇵Shinjuku-Ku, Tokyo, Japan
Medical Corporation Seikokai Takanoko Hospital
🇯🇵Matsuyama-shi, Ehime, Japan
DOI CL Intern. Med./Neurol.
🇯🇵Hiroshima-shi, Hiroshima, Japan
DOI CLINIC Internal Medicine/Neurology
🇯🇵Hiroshima-shi, Hiroshima, Japan
Nishinomiya Municipal Central Hospital
🇯🇵Nishinomiya-shi, Hyogo, Japan
Sendai Headache and Neurology Clinic, Medical Corporation
🇯🇵Sendai-shi, Miyagi, Japan
Medical corporation oblige Ooba Clinic for Neurosurgery & Headache
🇯🇵Oita-shi, Oita, Japan
Ooba CL Neurosurg. & Headache
🇯🇵Oita-shi, Oita, Japan
Makabe Clinic
🇯🇵Okayama-shi, Okayama, Japan
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai
🇯🇵Osaka-city, Osaka, Japan
Dokkyo Medical University Hospital
🇯🇵Shimotsuga-gun, Tochigi, Japan
Shinagawa Strings Clinic
🇯🇵Minato-Ku, Tokyo, Japan
Tdc Ichikawa General Hospital
🇯🇵Ichikawa-shi, Chiba, Japan
Tokyo Dental College Ichikawa General Hospital
🇯🇵Ichikawa-shi, Chiba, Japan
Ota Memorial Hospital
🇯🇵Ota-shi, Gunma, Japan
St. Marianna Univ. Hospital
🇯🇵Kawasaki-shi, Kanagawa, Japan
Saisekai Kumamot Hospital
🇯🇵Kumamoto-shi, Kumamoto, Japan
Tominaga Clinic
🇯🇵Osaka-shi, Osaka, Japan
Kitano Hospital,Tazuke Kofukai Medical Research Institute
🇯🇵Osaka-shi, Osaka, Japan
Saitama Medical University Hospital
🇯🇵Iruma-gun, Saitama, Japan
Nagamitsu Clinic
🇯🇵Hofu-shi, Yamaguchi, Japan
Tokyo Headache Clinic
🇯🇵Shibuya-Ku, Tokyo, Japan
Japanese Red Cross Shizuoka Hospital
🇯🇵Shizuoka-shi, Shizuoka, Japan
Dokkyo Medical Univ. Hosp.
🇯🇵Shimotsuga-gun, Tochigi, Japan
Tokai university hachioji hospital
🇯🇵Hachioji-shi, Tokyo, Japan
USUDA CLINIC for internal medicine
🇯🇵Setagaya-Ku, Tokyo, Japan
Nishiogi Pain Clinic
🇯🇵Suginami-Ku, Tokyo, Japan
Nagaseki Headache Clinic
🇯🇵Kai-shi, Yamanashi, Japan
Keio University Hospital
🇯🇵Shinjuku-Ku, Tokyo, Japan