Clinical trial NCT05399485: Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rimegepant for Migraine Prevention in Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine
Headache
Migraine Prevention
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-06-01
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is being conducted to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the prevention of migraine.


Eligibility criteria: 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:

1. Age of onset of migraines prior to 50 years of age
2. Migraine attacks, on average, lasting 4 to 72 hours if untreated
3. 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. 4 or more migraine days during Observation Period
5. Not more than 18 headache days during the Observation Period
6. Ability to distinguish migraine attacks from tension/cluster headaches
7. 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.
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. 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.
3. 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.
4. Subject with a history of HIV disease
5. 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
6. 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)
7. 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.
8. 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
9. 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.
10. 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.
11. Participation in any other investigational clinical trial while participating in this clinical trial

Primary outcomes:
measure: 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
timeFrame: Weeks 9 to 12 of DBT phase
Secondary outcomes:
measure: 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
timeFrame: Weeks 9 to 12 of DBT phase
measure: Reduction from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment (DBT) phase
timeFrame: Observation Period (OP) and Week 1 to 12 of DBT Phase
measure: Frequency of use of acute migraine specific medication (i.e., triptans and ergotamines) in the last 4 weeks of the double-blind treatment phase
timeFrame: Weeks 9 to 12 of DBT Phase
measure: Reduction from baseline in the mean number of migraine days per month in the first 4 weeks of the double-blind treatment phase
timeFrame: OP and Weeks 1 to 4 of DBT Phase
measure: 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
timeFrame: Baseline, Week 12 of DBT Phase
measure: Change from baseline in the Migraine Disability Assessment total score at Week 12 of the double-blind treatment phase
timeFrame: Baseline, Week 12 of DBT Phase
measure: Change from baseline in the EQ-5D-5L score at Week 12 of the double blind treatment phase
timeFrame: Baseline, Week 12 of DBT Phase
measure: Number of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to drug discontinuation
timeFrame: Through study completion, 52 weeks
measure: Number of participants with clinical significant laboratory abnormalities
timeFrame: Through study completion, 52 weeks
measure: Frequency of ALT or AST > 3x ULN with concurrent elevations in bilirubin >2x ULN in subjects treated with rimegepant
timeFrame: Through study completion, 52 weeks
measure: Number of participants with hepatic-related adverse events (AEs) and the frequency of hepatic-related treatment discontinuations in subjects treated with rimegepant
timeFrame: Through study completion, 52 weeks
Other outcomes:
Locations:
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 Clinic Internal Medicine/Neurology
state: Hiroshima
city: Asahikawa-shi
country: Japan
facility: Japanese Red Cross Asahikawa Hospital
state: Hokkaido
city: Chuo-ku
country: Japan
facility: Nakamura Memorial Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Higashi Sapporo Neurology and Neurosurgery Clinic
state: Hokkaido
city: Higashinada-ku
country: Japan
facility: Konan Medical Center
state: Hyōgo
city: Nishinomiya-shi
country: Japan
facility: Nishinomiya Munic. Ctr. Hosp.
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 Medical University Uchimaru Medical Center
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: Kyoto-shi
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: Sendai-shi
country: Japan
facility: Sendai Headache and Neurology Clinic, Medical Corporation
state: Miyagi
city: Oita-shi
country: Japan
facility: Ooba Clinic for Neurosurgery & 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: Osaka-city
country: Japan
facility: Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai
state: Osaka
city: Osaka-shi
country: Japan
facility: Tominaga Clinic
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: Saitama-shi
country: Japan
facility: Saitama Neuropsychiatric Institute
state: Saitama
city: Shizuoka-shi
country: Japan
facility: Japanese Red Cross 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 univ. hachioji hosp.
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: 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: 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: