Clinical trial NCT05399459: Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)
Official title: Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine
Headache
Acute Migraine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-06-01
Enrollment: 897
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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 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), hemiplegic migraine or retinal 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 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.
4. Uncontrolled hypertension or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to screening).
5. Subject with other pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments.
6. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has a disease that causes malabsorption.
7. The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or 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.
8. History of alcohol abuse and/or illicit drug use meeting DSM-V criteria for substance use disorder within 6 months of screening.
9. Participation in any other investigational clinical trial while participating in this clinical trial.

Primary outcomes:
measure: Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
Secondary outcomes:
measure: Percentage of Participants With Pain Relief at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants Who Had Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Ability to Function Normally at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-Dose
timeFrame: 2 to 24 hours post-dose
measure: Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-Dose
timeFrame: Within 24 hours post-dose
measure: Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-Dose
timeFrame: 2 to 48 hours post-dose
measure: Percentage of Participants With Absence of Photophobia at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-Dose
timeFrame: 2 to 24 hours post-dose
measure: Percentage of Participants With Freedom of Phonophobia at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-Dose
timeFrame: 2 to 48 hours post-dose
measure: Percentage of Participants With Freedom From Nausea at 2 Hours Post Dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-Dose
timeFrame: 2 to 48 hours post-dose
measure: Number of Participants With Adverse Events (AEs) by Intensity
timeFrame: From the day of signing informed consent up to end of treatment visit (approximately maximum up to 11 weeks)
measure: Number of Participants With Serious AEs
timeFrame: From the day of signing informed consent up to end of treatment visit (approximately maximum up to 11 weeks)
measure: Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities- Hematology
timeFrame: Baseline (Day 1) up to End of treatment visit (within 7 days of treatment) [approximately maximum up to 7 weeks]
measure: Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities- Serum Chemistry
timeFrame: Baseline (Day 1) up to End of treatment visit (within 7 days of treatment) [approximately maximum up to 7 weeks]
measure: Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities- Urinalysis
timeFrame: Baseline (Day 1) up to End of treatment visit (within 7 days of treatment) [approximately maximum up to 7 weeks]
Other outcomes:
Locations:
city: Ichikawa-shi
country: Japan
facility: Tokyo Dental College Ichikawa General Hospital
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Medical Corporation Seikokai Takanoko Hospital
state: Ehime
city: Kasuga-shi
country: Japan
facility: Jinnouchi Neurosurgical Clinic
state: Fukuoka
city: Kasuga-shi
country: Japan
facility: Ikeda Neurosurgical Clinic
state: Fukuoka
city: Ota-shi
country: Japan
facility: SUBARU Health Insurance Society Ota Memorial Hospital
state: Gunma
city: Hiroshima-shi
country: Japan
facility: DOI CL Intern. Med./Neurol.
state: Hiroshima
city: Asahikawa-shi
country: Japan
facility: Japanese Red Cross Asahikawa Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Higashi Sapporo Neurology and Neurosurgery Clinic
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Nakamura Memorial Hospital
state: Hokkaido
city: Nishinomiya-shi
country: Japan
facility: Nishinomiya Municipal Central Hospital
state: Hyogo
city: Kobe-shi
country: Japan
facility: Konan Medical Center
state: Hyōgo
city: Mito-shi
country: Japan
facility: Mito Kyodo General Hospital
state: Ibaraki
city: Kahoku-gun
country: Japan
facility: Kijima Neurosurgery Clinic
state: Ishikawa
city: Morioka-shi
country: Japan
facility: Iwate Med. Univ. Uchimaru MC
state: Iwate
city: Kagoshima-shi
country: Japan
facility: Atsuchi Neurosurgery Hospital
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Tanaka Neurosurgical Clinic
state: Kagoshima
city: Kawasaki-shi
country: Japan
facility: St. Marianna Univ. Hospital
state: Kanagawa
city: Nakahara
country: Japan
facility: Fujitsu Clinic
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Saiseikai Kumamoto Hospital
state: Kumamoto
city: Kumiyama-cho
country: Japan
facility: Kyoto Okamoto Memorial Hospital
state: Kyoto
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
state: Kyoto
city: Sakyo-ku
country: Japan
facility: Ishikawa Clinic
state: Kyoto
city: Shimogyo-ku
country: Japan
facility: Tatsuoka Neurology Clinic
state: Kyoto
city: Kochi-shi
country: Japan
facility: Atago Hospital
state: Kōchi
city: Kochi-shi
country: Japan
facility: Umenotsuji Clinic
state: Kōchi
city: Izumi-ku
country: Japan
facility: Narikawa Neurological Clinic
state: Miyagi
city: Sendai-shi
country: Japan
facility: Sendai Headache and Neurology Clinic, Medical Corporation
state: Miyagi
city: Oita-shi
country: Japan
facility: Ooba CL Neurosurg. & Headache
state: Oita
city: Okayama-shi
country: Japan
facility: Makabe Clinic
state: Okayama
city: Okayama-shi
country: Japan
facility: Okayama City General Medical Center Okayama City Hospital
state: Okayama
city: Naniwa-ku
country: Japan
facility: Tominaga Clinic
state: Osaka
city: Osaka-city
country: Japan
facility: Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Toyonaka-shi
country: Japan
facility: Takase Intern. Med. Clinic
state: Osaka
city: Iruma-gun
country: Japan
facility: Saitama Medical University Hospital
state: Saitama
city: Shizuoka-shi
country: Japan
facility: JRC Shizuoka Hospital
state: Shizuoka
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical Univ. Hosp.
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Hachioji-shi
country: Japan
facility: Tokai university hachioji hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Shinagawa Strings Clinic
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo
city: Setagaya-ku
country: Japan
facility: USUDA CLINIC for internal medicine
state: Tokyo
city: Shibuya-Ku
country: Japan
facility: Tokyo Headache Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Fukuuchi Pain Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Suginami-ku
country: Japan
facility: Nishiogi Pain Clinic
state: Tokyo
city: Tachikawa-city
country: Japan
facility: Suzuki Kei Yasuragi clinic
state: Tokyo
city: Toyama-shi
country: Japan
facility: Sakura Neuro Clinic
state: Toyama
city: Hofu-shi
country: Japan
facility: Nagamitsu Clinic
state: Yamaguchi
city: Kai-shi
country: Japan
facility: Nagaseki Headache Clinic
state: Yamanashi
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: