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NCT05399485 | Active, not recruiting | Migraine

Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)
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.

Condition or disease

Migraine

Intervention/treatment

Rimegepant

Placebo

Phase

Phase 3

Study Type : Interventional
Estimated Enrollment : 496 participants
Masking : Quadruple
Primary Purpose : Prevention
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
Actual Study Start Date : August 9, 2022
Estimated Primary Completion Date : January 18, 2024
Estimated Study Completion Date : November 9, 2024
Arm Intervention/treatment

Experimental: Rimegepant

Randomization Phase: one 75 mg rimegepant (BHV3000) oral disintegration tablet every other day until Week 12

Drug: Rimegepant

Placebo Comparator: Placebo

Randomization Phase: one matching placebo every other day until week 12

Drug: Placebo
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
    • 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
    Exclusion 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
Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)

Location Details

Please Choose a site

Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Japan, Ehime

Medical Corporation Seikokai Takanoko Hospital

Mr. Matsuyama, Ehime, Japan, 790-0925

Not yet recruiting

Japan, Fukuoka

Jinnouchi Neurosurgical Clinic

Mr. Kasuga, Fukuoka, Japan, 816-0802

Not yet recruiting

Japan, Fukuoka

Ikeda Neurosurgical Clinic

Mr. Kasuga, Fukuoka, Japan, 816-0824

Not yet recruiting

Japan, Gunma

SUBARU Health Insurance Society Ota Memorial Hospital

OTA-yes, Gunma, Japan, 373-8585

Not yet recruiting

Japan, Hiroshima

Doi Clinic Internal Medicine/Neurology

Hiroshima, Hiroshima, Japan, 730-0031

Not yet recruiting

Japan, Hokkaido

Japanese Red Cross Asahikawa Hospital

Mr. Asahikawa, Hokkaido, Japan, 070-8530

Not yet recruiting

Japan, Hokkaido

Nakamura Memorial Hospital

Chuok, Sapporo, Hokkaido, Japan, 060-8570

Not yet recruiting

Japan, Hokkaido

Higashi Sapporo Neurology and Neurosurgery Clinic

Mr. Sapporo, Hokkaido, Japan, 003-0003

Not yet recruiting

Japan, Hokkaido

Higashi Sapporo Neuro. C.L.

It's white and Sapporo, Hokkaido, Japan, 003-0003

Not yet recruiting

Japan, Hyōgo

Konan Medical Center

Eastern dark, Kobe, Hyogo, Japan, 658-0064

Not yet recruiting

Japan, Hyōgo

Nishinomiya Muji c. Ctr. Supplementary sp.

Mr. Nishinomiya, Hyogo, Japan, 663-8014

Not yet recruiting

Japan, Ibaraki

Myth Kyodo General Hospital

My Tho city, Ibaraki, Japan, 310-0015

Not yet recruiting

Japan, Ishikawa

Kijima Neurosurgery Clinic

Hebei army, Ishikawa, Japan, 929-0342

Not yet recruiting

Japan, Iwate

Yuvade Medical University Uchimmaru Medical Centre

Mr. Morioka, Iwate, Japan, 020-8505

Not yet recruiting

Japan, Kagoshima

Atsuchi Neurosurgery Hospital

Mr. Kagoshima, Kagoshima, Japan, 892-0842

Not yet recruiting

Japan, Kagoshima

Tanaka Neurosurgical Clinic

Mr. Kagoshima, Kagoshima, Japan, 892-0844

Not yet recruiting

Japan, Kanagawa

St. Marianna University. Hospital

Mr. Kawasaki, Kanagawa, Japan, 216-8511

Not yet recruiting

Japan, Kanagawa

Unfaithful Cini c

Nakahara, Kawasaki, Kanagawa, Japan, 211-8588

Not yet recruiting

Japan, Kumamoto

Saiseikai Kumamoto supplementary pita l

Mr. Kumamoto, Kumamoto, Japan, 861- 4193

Not yet recruiting

Japan, Kumamoto

Saisekai Scratch Hospital

Mr. Kumamoto, Kumamoto, Japan, 861-4193

Not yet recruiting

Japan, Kyoto

Tatsuoka Neurology Clinic

Itoshi, Kyoto, Japan, 600-8811

Not yet recruiting

Japan, Kōchi

Atago Hospital

kochi-is, Kōchi, Japan, 780-0051

Not yet recruiting

Japan, Kōchi

Umenotsuji Cini c

kochi-is, Kōchi, Japan, 780-8011

Not yet recruiting

Japan, Miyagi

Sendai Headache and Neurology Clinic, Medical Corporation

Mr. Sendai, Miyagi, Japan, 982-0014

Not yet recruiting

Japan, And do it

Ooba Clinic for Neurosurgery & Headache

Mr. Oita, And do, Japan, 870-0831

Not yet recruiting

Japan, Okayama

Make it a clinic

Mr. Okayama, Okayama, Japan, 700-0964

Not yet recruiting

Japan, Okayama

Okayama City General Medical Center Okayama City Hospital

Mr. Okayama, Okayama, Japan, 700-8557

Not yet recruiting

Japan, Osaka

Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai

Osaka city, Osaka, Japan, 530-8480

Not yet recruiting

Japan, Osaka

Kita's assistant pita l Tazuke Kodeep

Soccer, Osaka, Japan, 530-8480

Not yet recruiting

Japan, Osaka

Kitano Hospital,Tazuke Kofukai Medical Research Institute

Soccer, Osaka, Japan, 530-8480

Not yet recruiting

Japan, Osaka

Tominaga Clinic

Soccer, Osaka, Japan, 556-0015

Not yet recruiting

Japan, Osaka

Kindai University Hospital

Upside-down Saya Merci, Osaka, Japan, 589-8511

Not yet recruiting

Japan, Osaka

Takase Intern. Med. Clinic

Mr. Toyonaka, Osaka, Japan, 560-0012

Not yet recruiting

Japan, Saitama

Saitama Medical University Hospital

Iruma army, Saitama, Japan, 350-0495

Not yet recruiting

Japan, Saitama

Saitama Neuropsychiatric Institute

Mr. Saitama, Saitama, Japan, 338-8577

Not yet recruiting

Japan, Shizuoka

Japanese Red Cross Shizuoka Hospital

Shizuoka-yes, Shizuoka, Japan, 420-0853

Not yet recruiting

Japan, Shizuoka

JRC Shizuoka Hospital

Shizuoka-yes, Shizuoka, Japan, 420-0853

Not yet recruiting

Japan, Tochigi

Dokkyo Medical University. Hospital.

Shimotsuga Army, Tochigi, Japan, 321-0293

Not yet recruiting

Japan, Tokyo

Juntendo University Hospital

Bunkyo Ward, Tokyo, Japan, 113-8431

Not yet recruiting

Japan, Tokyo

Urban sea urchin v. 8 uncle supplementary sp.

8 uncle, Tokyo, Japan, 192-0032

Not yet recruiting

Japan, Tokyo

Shinagawa Stbayashi gs Cini c

Everyone talk, Tokyo, Japan, 108-0075

Not yet recruiting

Japan, Tokyo

Kitasato University Kitasato Institute Hospital

Everyone talk, Tokyo, Japan, 108-8642

Not yet recruiting

Japan, Tokyo

USUDA CLINIC for internal medicine

Setagaya Ward, Tokyo, Japan, 156-0043

Not yet recruiting

Japan, Tokyo

Fukuuchi Pain Clinic

Shinjuku-ku, Tokyo, Japan, 160-0017

Not yet recruiting

Japan, Tokyo

Keio University Hospital

Shinjuku-ku, Tokyo, Japan, 160-8582

Not yet recruiting

Japan, Tokyo

Nishiogi Pine Cini c

Suginami Ward, Tokyo, Japan, 167-0054

Not yet recruiting

Japan, Toyama

Sakura Clinic

Mr. Toyama, Toyama, Japan, 930-0803

Not yet recruiting

Japan, Toyama

Sakura Neuro Clinic

Mr. Toyama, Toyama, Japan, 930-0803

Not yet recruiting

Japan, Yamaguchi

Nagamitsu Cini c

Mr. Hoffu, Yamaguchi, Japan, 747-0802

Not yet recruiting

Japan, Yamanashi

Long seat hair che Cini c

Kai-is, Yamanashi, Japan, 400-0124