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

• Sponsor: Biohaven Pharmaceuticals, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05399485
• Collaborator: (none)
• Enrollment: 490
• Locations: 43
• Arms: 2
• Anticipated Duration (Months): 26
• Patients Per Site: 11.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	Intervention/Treatment	Phase
Migraine	Drug: Rimegepant; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 490 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• 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: Aug 9, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Oct 7, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rimegepant Randomization Phase: one 75 mg rimegepant (BHV3000) oral disintegration tablet every other day until Week 12	Drug: Rimegepant; Randomization Phase: Rimegepant (BHV3000) 75 mg orally disintegrating tablet every other day until Week 12; Other Names: BHV3000
Placebo Comparator: Placebo Randomization Phase: one matching placebo every other day until week 12	Drug: Placebo; Randomization Phase: Placebo tablet to match Rimegepant every other day until Week 12

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

5. 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]

6. 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]

7. Change from baseline in the EQ-5D-5L score at Week 12 of the double blind treatment phase and at Week 24 and Week 52 of the open-label extension (OLE) phase [Baseline, Week 12 of DBT Phase, Week 24 and Week 52 of OLE phase]

8. Number of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to drug discontinuation [Through study completion, 52 weeks]

9. Number of participants with clinical significant laboratory abnormalities [Through study completion, 52 weeks]

10. Frequency of ALT or AST > 3x ULN with concurrent elevations in bilirubin >2x ULN in subjects treated with rimegepant [Through study completion, 52 weeks]

11. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Corporation Seikokai Takanoko Hospital	Matsuyama-shi	Ehime	Japan	790-0925
2	Jinnouchi Neurosurgical Clinic	Kasuga-shi	Fukuoka	Japan	816-0802
3	Ikeda Neurosurgical Clinic	Kasuga-shi	Fukuoka	Japan	816-0824
4	Ota Memorial Hospital	Ota-shi	Gunma	Japan	375-8585
5	DOI CLINIC Internal Medicine/Neurology	Hiroshima-shi	Hiroshima	Japan	730-0031
6	Japanese Red Cross Asahikawa Hospital	Asahikawa-shi	Hokkaido	Japan	070-8530
7	Nakamura Memorial Hospital	Sapporo shi	Hokkaido	Japan	060-8570
8	Higashi Sapporo Neurology and Neurosurgery Clinic	Sapporo-shi	Hokkaido	Japan	003-0003
9	Konan Medical Center	Kobe shi	Hyogo	Japan	658-0064
10	Nishinomiya Municipal Central Hospital	Nishinomiya-shi	Hyogo	Japan	663-8014
11	Mito Kyodo General Hospital	Mito-shi	Ibaraki	Japan	310-0015
12	Kijima Neurosurgery Clinic	Kahoku-gun	Ishikawa	Japan	929-0342
13	Iwate Medical University Uchimaru Medical Center	Morioka-shi	Iwate	Japan	020-8505
14	Atsuchi Neurosurgery Hospital	Kagoshima-shi	Kagoshima	Japan	892-0842
15	Tanaka neurosurgical clinic	Kagoshima-shi	Kagoshima	Japan	892-0844
16	Fujitsu Clinic	Kawasaki-shi	Kanagawa	Japan	211-8588
17	St. Marianna University Hospital	Kawasaki-shi	Kanagawa	Japan	216-8511
18	Atago Hospital	Kochi-shi	Kochi	Japan	780-0051
19	Umenotsuji Clinic	Kochi-shi	Kochi	Japan	780-8011
20	Tatsuoka Neurology Clinic	Kyoto-shi	Kyoto	Japan	600-8811
21	Sendai Headache and Neurology Clinic, Medical Corporation	Sendai-shi	Miyagi	Japan	982-0014
22	Medical corporation oblige Ooba Clinic for Neurosurgery & Headache	Oita-shi	Oita	Japan	870-0831
23	Makabe Clinic	Okayama-shi	Okayama	Japan	700-0964
24	Okayama City General Medical Center Okayama City Hospital	Okayama-shi	Okayama	Japan	700-8557
25	Kitano Hospital,Tazuke Kofukai Medical Research Institute	Osaka-shi	Osaka	Japan	530-8480
26	Tominaga Clinic	Osaka-shi	Osaka	Japan	556-0015
27	Kindai University Hospital	Osakasayama-shi	Osaka	Japan	589-8511
28	Takase Internal Medicine Clinic	Toyonaka-shi	Oska	Japan	560-0012
29	Saitama Medical University Hospital	Iruma-gun	Saitama	Japan	350-0495
30	Saitama Neuropsychiatric Institute	Saitama-shi	Saitama	Japan	338-8577
31	Japanese Red Cross Shizuoka Hospital	Shizuoka-shi	Shizuoka	Japan	420-0853
32	Dokkyo Medical University Hospital	Shimotsuga-gun	Tochigi	Japan	321-0293
33	Juntendo University Hospital	Bunkyō-Ku	Tokyo	Japan	113-8431
34	Tokai university hachioji hospital	Hachioji-shi	Tokyo	Japan	192-0032
35	Shinagawa Strings Clinic	Minato-Ku	Tokyo	Japan	108-0075
36	Kitasato University Kitasato Institute Hospital	Minato-Ku	Tokyo	Japan	108-8642
37	USUDA CLINIC for internal medicine	Setagaya-Ku	Tokyo	Japan	156-0043
38	Fukuuchi Pain Clinic	Shinjuku-Ku	Tokyo	Japan	160-0017
39	Keio University Hospital	Shinjuku-Ku	Tokyo	Japan	160-8582
40	Nishiogi Pain Clinic	Suginami-Ku	Tokyo	Japan	167-0054
41	Sakura Clinic	Toyama-shi	Toyama	Japan	930-0803
42	Nagamitsu Clinic	Hofu-shi	Yamaguchi	Japan	747-0802
43	Nagaseki Headache Clinic	Kai-shi	Yamanashi	Japan	400-0124

Sponsors and Collaborators

• Biohaven Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biohaven Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT05399485
• Other Study ID Numbers: BHV3000-309
• First Posted: Jun 1, 2022
• Last Update Posted: Aug 17, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Biohaven Pharmaceuticals, Inc.: Migraine; Headache; Migraine Prevention
• Additional relevant MeSH terms: Migraine Disorders

Study Results

No Results Posted as of Aug 17, 2022