Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05399459
• Other study ID #: BHV3000-313
• Secondary ID: C4951022
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

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

External Links

•   To obtain contact information for a study center near you, click here.