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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05399459
Other study ID # BHV3000-313
Secondary ID C4951022
Status Completed
Phase Phase 3
First received
Last updated
Start date August 9, 2022
Est. completion date January 19, 2024

Study information

Verified date April 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 803
Est. completion date January 19, 2024
Est. primary completion date January 19, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: 1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age 2. Migraine attacks, on average, lasting about 4-72 hours if untreated 3. Not more than 8 attacks of moderate to severe intensity per month within the last 3 months 4. Ability to distinguish migraine attacks from tension/cluster headaches 5. 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 6. 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. 7. 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. 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. 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. 3. Subject with a history of HIV disease 4. 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 5. 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) 6. 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. 7. 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 8. 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. 9. 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. 10. Participation in any other investigational clinical trial while participating in this clinical trial

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rimegepant 25 MG
Single dose of 25 mg orally disintegrating tablet of rimegepant
Rimegepant 75 MG
Single dose of 75 mg orally disintegrating tablet of rimegepant
Placebo
Matching placebo tablet

Locations

Country Name City State
Japan Japanese Red Cross Asahikawa Hospital Asahikawa-shi Hokkaido
Japan Juntendo University Hospital Bunkyo-ku Tokyo
Japan Juntendo University Hospital Bunkyo-Ku Tokyo
Japan Tokai university hachioji hospital Hachioji-shi Tokyo
Japan DOI CL Intern. Med./Neurol. Hiroshima-shi Hiroshima
Japan DOI CLINIC Internal Medicine/Neurology Hiroshima-shi Hiroshima
Japan Nagamitsu Clinic Hofu-shi Yamaguchi
Japan Tdc Ichikawa General Hospital Ichikawa-shi Chiba
Japan Tokyo Dental College Ichikawa General Hospital Ichikawa-shi Chiba
Japan Saitama Medical University Hospital Iruma-gun Saitama
Japan Narikawa Neurological Clinic Izumi-ku, Sendai-city Miyagi
Japan Atsuchi Neurosurgery Hospital Kagoshima-shi Kagoshima
Japan Tanaka neurosurgical clinic Kagoshima-shi Kagoshima
Japan Kijima Neurosurgery Clinic Kahoku-gun Ishikawa
Japan Nagaseki Headache Clinic Kai-shi Yamanashi
Japan Ikeda Neurosurgical Clinic Kasuga-shi Fukuoka
Japan Jinnouchi Neurosurgical Clinic Kasuga-shi Fukuoka
Japan Fujitsu Clinic Kawasaki-shi Kanagawa
Japan St. Marianna Univ. Hospital Kawasaki-shi Kanagawa
Japan St. Marianna University Hospital Kawasaki-shi Kanagawa
Japan Konan Medical Center Kobe shi Hyogo
Japan Konan Medical Center Kobe-shi Hyogo
Japan Atago Hospital Kochi-shi Kochi
Japan Atago Hospital Kochi-shi Kochi
Japan Umenotsuji Clinic Kochi-shi Kochi
Japan Umenotsuji Clinic Kochi-shi Kochi
Japan Saiseikai Kumamoto Hospital Kumamoto-shi Kumamoto
Japan Saiseikai Kumamoto Hospital Kumamoto-shi Kumamoto
Japan Saisekai Kumamot Hospital Kumamoto-shi Kumamoto
Japan Kyoto Okamoto Memorial Hospital Kumiyama-cho, Kuse-gun Kyoto
Japan Tatsuoka Neurology Clinic Kyoto-shi Kyoto
Japan University Hospital Kyoto Prefectural University of Medicine Kyoto-shi Kyoto
Japan Medical Corporation Seikokai Takanoko Hospital Matsuyama-shi Ehime
Japan Kitasato Institute Hospital Minato-ku Tokyo
Japan Kitasato University Kitasato Institute Hospital Minato-Ku Tokyo
Japan Shinagawa Strings Clinic Minato-Ku Tokyo
Japan Mito Kyodo General Hospital Mito-shi Ibaraki
Japan Iwate Med. Univ. Uchimaru MC Morioka-shi Iwate
Japan Iwate Medical University Uchimaru Medical Center Morioka-shi Iwate
Japan Fujitsu Clinic Nakahara, Kawasaki Kanagawa
Japan Tominaga Clinic Naniwa-ku, Osaka-shi Osaka
Japan Nishinomiya Municipal Central Hospital Nishinomiya-shi Hyogo
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 Okayama City General Medical Center Okayama City Hospital Okayama-shi Okayama
Japan Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai Osaka-city Osaka
Japan Kitano Hospital,Tazuke Kofukai Medical Research Institute Osaka-shi Osaka
Japan Tominaga Clinic Osaka-shi Osaka
Japan Kindai University Hospital Osakasayama-shi Osaka
Japan Ota Memorial Hospital Ota-shi Gunma
Japan SUBARU Health Insurance Society Ota Memorial Hospital Ota-shi Gunma
Japan SUBARU Health Insurance Society Ota Memorial Hospital Ota-shi Gunma
Japan Saitama Neuropsychiatric Institute Saitama-shi Saitama
Japan Ishikawa Clinic Sakyo-ku, Kyoto-city Kyoto
Japan Nakamura Memorial Hospital Sapporo shi Hokkaido
Japan Higashi Sapporo Neurology and Neurosurgery Clinic Sapporo-shi Hokkaido
Japan Nakamura Memorial Hospital Sapporo-shi Hokkaido
Japan Sendai Headache and Neurology Clinic, Medical Corporation Sendai-shi Miyagi
Japan USUDA CLINIC for internal medicine Setagaya-Ku Tokyo
Japan Tokyo Headache Clinic Shibuya-Ku Tokyo
Japan Tatsuoka Neurology Clinic Shimogyo-ku, Kyoto Kyoto
Japan Dokkyo Medical Univ. Hosp. Shimotsuga-gun Tochigi
Japan Dokkyo Medical University Hospital Shimotsuga-gun Tochigi
Japan Fukuuchi Pain Clinic Shinjuku-Ku Tokyo
Japan Keio University Hospital Shinjuku-Ku Tokyo
Japan Japanese Red Cross Shizuoka Hospital Shizuoka-shi Shizuoka
Japan JRC Shizuoka Hospital Shizuoka-shi Shizuoka
Japan Nishiogi Pain Clinic Suginami-Ku Tokyo
Japan Suzuki Kei Yasuragi clinic Tachikawa-city Tokyo
Japan Sakura Clinic Toyama-shi Toyama
Japan Sakura Neuro Clinic Toyama-shi Toyama
Japan Takase Intern. Med. Clinic Toyonaka-shi Osaka
Japan Takase Internal Medicine Clinic Toyonaka-shi Oska

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain freedom at 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). 2 hours post-dose
Secondary Pain relief at 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 Baseline, 2 hours post-dose
Secondary Freedom from the Most Bothersome Symptom (MBS) associated with migraine at 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) 2 hours post-dose
Secondary Ability to function normally at 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. 2 hours post-dose
Secondary Sustained pain relief from 2 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. From 2 hours up to 24 hours post-dose
Secondary Frequency of use of rescue medication within 24 hours of initial treatment. Measured by the number of subjects that take rescue medication within 24 after administration of study medication 24 hours post-dose
Secondary Sustained pain relief from 2 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. From 2 hours up to 48 hours post-dose
Secondary Freedom from photophobia at 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 Baseline, 2 hours post-dose
Secondary Sustained pain freedom from 2 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 From 2 hours up to 24 hours post-dose
Secondary Freedom from phonophobia at 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 Baseline, 2 hours post-dose
Secondary Sustained pain freedom from 2 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. From 2 hours up to 48 hours post-dose
Secondary Freedom from nausea at 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 Baseline, 2 hours post-dose
Secondary Incidence of pain relapse from 2 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 From 2 hours up to 48 hours post-dose
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