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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05399485
• Other study ID #: BHV3000-309
• Secondary ID: C4951021
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 9, 2022
• Est. completion date: November 9, 2024

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 496
• Est. completion date: November 9, 2024
• Est. primary completion date: January 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Rimegepant
Randomization Phase: Rimegepant (BHV3000) 75 mg orally disintegrating tablet every other day until Week 12
• Placebo
Randomization Phase: Placebo tablet to match Rimegepant every other day until Week 12

Locations

Country	Name	City	State
Japan	Japanese Red Cross Asahikawa Hospital	Asahikawa-shi	Hokkaido
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	Nakamura Memorial Hospital	Chuo-ku, Sapporo-shi	Hokkaido
Japan	Tokai univ. hachioji hosp.	Hachioji-shi	Tokyo
Japan	Konan Medical Center	Higashinada-ku, Kobe	Hyogo
Japan	Doi Clinic Internal Medicine/Neurology	Hiroshima-shi	Hiroshima
Japan	Nagamitsu Clinic	Hofu-shi	Yamaguchi
Japan	Saitama Medical University Hospital	Iruma-gun	Saitama
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	St. Marianna Univ. Hospital	Kawasaki-shi	Kanagawa
Japan	Atago Hospital	Kochi-shi	Kochi
Japan	Umenotsuji Clinic	Kochi-shi	Kochi
Japan	Saiseikai Kumamoto Hospital	Kumamoto-shi	Kumamoto
Japan	Saisekai Kumamot Hospital	Kumamoto-shi	Kumamoto
Japan	Tatsuoka Neurology Clinic	Kyoto-shi	Kyoto
Japan	Medical Corporation Seikokai Takanoko Hospital	Matsuyama-shi	Ehime
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 Medical University Uchimaru Medical Center	Morioka-shi	Iwate
Japan	Fujitsu Clinic	Nakahara, Kawasaki	Kanagawa
Japan	Nishinomiya Munic. Ctr. Hosp.	Nishinomiya-shi	Hyogo
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	Kitano Hospital Tazuke Kofukai	Osaka-shi	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	SUBARU Health Insurance Society Ota Memorial Hospital	Ota-shi	Gunma
Japan	Saitama Neuropsychiatric Institute	Saitama-shi	Saitama
Japan	Higashi Sapporo Neurology and Neurosurgery Clinic	Sapporo-shi	Hokkaido
Japan	Sendai Headache and Neurology Clinic, Medical Corporation	Sendai-shi	Miyagi
Japan	USUDA CLINIC for internal medicine	Setagaya-ku	Tokyo
Japan	Dokkyo Medical Univ. Hosp.	Shimotsuga-gun	Tochigi
Japan	Fukuuchi Pain Clinic	Shinjuku-ku	Tokyo
Japan	Keio University Hospital	Shinjuku-ku	Tokyo
Japan	Higashi Sapporo Neuro. CL	Shiroishi, Sapporo	Hokkaido
Japan	Japanese Red Cross Shizuoka Hospital	Shizuoka-shi	Shizuoka
Japan	JRC Shizuoka Hospital	Shizuoka-shi	Shizuoka
Japan	Nishiogi Pain Clinic	Suginami-ku	Tokyo
Japan	Sakura Clinic	Toyama-shi	Toyama
Japan	Sakura Neuro Clinic	Toyama-shi	Toyama
Japan	Takase Intern. Med. Clinic	Toyonaka-shi	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline in the EQ-5D-5L score at Week 12 of the double blind treatment phase		Baseline, Week 12 of DBT Phase
Secondary	Number of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to drug discontinuation		Through study completion, 52 weeks
Secondary	Number of participants with clinical significant laboratory abnormalities		Through study completion, 52 weeks
Secondary	Frequency of ALT or AST > 3x ULN with concurrent elevations in bilirubin >2x ULN in subjects treated with rimegepant		Through study completion, 52 weeks
Secondary	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

External Links

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