Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)
- Registration Number
- NCT05399485
- Lead Sponsor
- Pfizer
- Brief Summary
This study is being conducted to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the prevention of migraine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 496
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 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 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 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.
- 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
- 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.
- 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, 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 Placebo Placebo Randomization Phase: one matching placebo every other day until week 12 Rimegepant Rimegepant Randomization Phase: one 75 mg rimegepant (BHV3000) oral disintegration tablet every other day until Week 12
- Primary Outcome Measures
Name Time Method Reduction from baseline in the mean number of migraine days per month in the last four weeks (week 9 to 12) of the double-blind treatment (DBT) phase Weeks 9 to 12 of DBT phase
- Secondary Outcome Measures
Name Time Method Number of participants with clinical significant laboratory abnormalities Through study completion, 52 weeks Reduction from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment (DBT) phase Observation Period (OP) and Week 1 to 12 of DBT Phase Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v 2.1 role function - restrictive domain score at Week 12 of the double-blind treatment phase Baseline, Week 12 of DBT Phase Change from baseline in the EQ-5D-5L score at Week 12 of the double blind treatment phase Baseline, Week 12 of DBT Phase Frequency of ALT or AST > 3x ULN with concurrent elevations in bilirubin >2x ULN in subjects treated with rimegepant Through study completion, 52 weeks Number of participants with hepatic-related adverse events (AEs) and the frequency of hepatic-related treatment discontinuations in subjects treated with rimegepant Through study completion, 52 weeks Number of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to drug discontinuation Through study completion, 52 weeks Frequency of use of acute migraine specific medication (i.e., triptans and ergotamines) in the last 4 weeks of the double-blind treatment phase Weeks 9 to 12 of DBT Phase Number of participants that have least a 50% reduction from baseline in the mean number of moderate to severe migraine days per month in the last 4 weeks of the double-blind treatment (DBT) phase Weeks 9 to 12 of DBT phase Reduction from baseline in the mean number of migraine days per month in the first 4 weeks of the double-blind treatment phase OP and Weeks 1 to 4 of DBT Phase Change from baseline in the Migraine Disability Assessment total score at Week 12 of the double-blind treatment phase Baseline, Week 12 of DBT Phase
Related Research Topics
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Trial Locations
- Locations (44)
Medical Corporation Seikokai Takanoko Hospital
🇯🇵Matsuyama-shi, Ehime, Japan
Jinnouchi Neurosurgical Clinic
🇯🇵Kasuga-shi, Fukuoka, Japan
Ikeda Neurosurgical Clinic
🇯🇵Kasuga-shi, Fukuoka, Japan
SUBARU Health Insurance Society Ota Memorial Hospital
🇯🇵Ota-shi, Gunma, Japan
Doi Clinic Internal Medicine/Neurology
🇯🇵Hiroshima-shi, Hiroshima, Japan
Japanese Red Cross Asahikawa Hospital
🇯🇵Asahikawa-shi, Hokkaido, Japan
Nakamura Memorial Hospital
🇯🇵Chuo-ku, Hokkaido, Japan
Higashi Sapporo Neurology and Neurosurgery Clinic
🇯🇵Sapporo-shi, Hokkaido, Japan
Konan Medical Center
🇯🇵Higashinada-ku, Hyōgo, Japan
Nishinomiya Munic. Ctr. Hosp.
🇯🇵Nishinomiya-shi, Hyōgo, Japan
Mito Kyodo General Hospital
🇯🇵Mito-shi, Ibaraki, Japan
Kijima Neurosurgery Clinic
🇯🇵Kahoku-gun, Ishikawa, Japan
Iwate Medical University Uchimaru Medical Center
🇯🇵Morioka-shi, Iwate, Japan
Atsuchi Neurosurgery Hospital
🇯🇵Kagoshima-shi, Kagoshima, Japan
Tanaka Neurosurgical Clinic
🇯🇵Kagoshima-shi, Kagoshima, Japan
St. Marianna Univ. Hospital
🇯🇵Kawasaki-shi, Kanagawa, Japan
Fujitsu Clinic
🇯🇵Nakahara, Kanagawa, Japan
Saiseikai Kumamoto Hospital
🇯🇵Kumamoto-shi, Kumamoto, Japan
Tatsuoka Neurology Clinic
🇯🇵Kyoto-shi, Kyoto, Japan
Atago Hospital
🇯🇵Kochi-shi, Kōchi, Japan
Umenotsuji Clinic
🇯🇵Kochi-shi, Kōchi, Japan
Sendai Headache and Neurology Clinic, Medical Corporation
🇯🇵Sendai-shi, Miyagi, Japan
Ooba Clinic for Neurosurgery & Headache
🇯🇵Oita-shi, Oita, Japan
Makabe Clinic
🇯🇵Okayama-shi, Okayama, Japan
Okayama City General Medical Center Okayama City Hospital
🇯🇵Okayama-shi, Okayama, Japan
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai
🇯🇵Osaka-city, Osaka, Japan
Tominaga Clinic
🇯🇵Osaka-shi, Osaka, Japan
Kindai University Hospital
🇯🇵Osakasayama-shi, Osaka, Japan
Takase Intern. Med. Clinic
🇯🇵Toyonaka-shi, Osaka, Japan
Saitama Medical University Hospital
🇯🇵Iruma-gun, Saitama, Japan
Saitama Neuropsychiatric Institute
🇯🇵Saitama-shi, Saitama, Japan
Japanese Red Cross Shizuoka Hospital
🇯🇵Shizuoka-shi, Shizuoka, Japan
Dokkyo Medical Univ. Hosp.
🇯🇵Shimotsuga-gun, Tochigi, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Tokai univ. hachioji hosp.
🇯🇵Hachioji-shi, Tokyo, Japan
Shinagawa Strings Clinic
🇯🇵Minato-ku, Tokyo, Japan
Kitasato University Kitasato Institute Hospital
🇯🇵Minato-ku, Tokyo, Japan
USUDA CLINIC for internal medicine
🇯🇵Setagaya-ku, Tokyo, Japan
Fukuuchi Pain Clinic
🇯🇵Shinjuku-ku, Tokyo, Japan
Keio University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Nishiogi Pain Clinic
🇯🇵Suginami-ku, Tokyo, Japan
Sakura Neuro Clinic
🇯🇵Toyama-shi, Toyama, Japan
Nagamitsu Clinic
🇯🇵Hofu-shi, Yamaguchi, Japan
Nagaseki Headache Clinic
🇯🇵Kai-shi, Yamanashi, Japan