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

• Sponsor: Biohaven Pharmaceuticals, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05399459
• Collaborator: (none)
• Enrollment: 795
• Locations: 44
• Arms: 3
• Anticipated Duration (Months): 16.8
• Patients Per Site: 18.1
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Rimegepant 25 MG; Drug: Rimegepant 75 MG; Drug: Placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 795 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 9, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Jan 2, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rimegepant 25 mg Single dose of 25 mg orally disintegrating tablet of rimegepant	Drug: Rimegepant 25 MG; Single dose of 25 mg orally disintegrating tablet of rimegepant; Other Names: BHV3000
Experimental: Rimegepant 75 mg Single dose of 75 mg orally disintegrating tablet of rimegepant	Drug: Rimegepant 75 MG; Single dose of 75 mg orally disintegrating tablet of rimegepant; Other Names: BHV3000
Placebo Comparator: Placebo Matching placebo tablet	Drug: Placebo; Matching placebo tablet

Outcome Measures

Primary Outcome Measures

1. Pain freedom at 2 hours post-dose [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).

Secondary Outcome Measures

1. Pain relief at 2 hours post-dose. [Baseline, 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

2. Freedom from the Most Bothersome Symptom (MBS) associated with migraine at 2 hours post-dose. [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)

3. Ability to function normally at 2 hours post-dose [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.

4. Sustained pain relief from 2 to 24 hours post-dose [From 2 hours up 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.

5. Frequency of use of rescue medication within 24 hours of initial treatment. [24 hours post-dose]

   Measured by the number of subjects that take rescue medication within 24 after administration of study medication

6. Sustained pain relief from 2 to 48 hours post-dose [From 2 hours up 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.

7. Freedom from photophobia at 2 hours post-dose [Baseline, 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

8. Sustained pain freedom from 2 to 24 hours post-dose [From 2 hours up 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

9. Freedom from phonophobia at 2 hours post-dose [Baseline, 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

10. Sustained pain freedom from 2 to 48 hours post-dose. [From 2 hours up 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.

11. Freedom from nausea at 2 hours post-dose [Baseline, 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

12. Incidence of pain relapse from 2 to 48 hours post-dose [From 2 hours up 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

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 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 one prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to screening visit 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. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tokyo Dental College Ichikawa General Hospital	Ichikawa-shi	Chiba	Japan	272-8513
2	Medical Corporation Seikokai Takanoko Hospital	Matsuyama-shi	Ehime	Japan	790-0925
3	Jinnouchi Neurosurgical Clinic	Kasuga-shi	Fukuoka	Japan	816-0802
4	Ikeda Neurosurgical Clinic	Kasuga-shi	Fukuoka	Japan	816-0824
5	Ota Memorial Hospital	Ota-shi	Gunma	Japan	375-8585
6	DOI CLINIC Internal Medicine/Neurology	Hiroshima-shi	Hiroshima	Japan	730-0031
7	Japanese Red Cross Asahikawa Hospital	Asahikawa-shi	Hokkaido	Japan	070-8530
8	Nakamura Memorial Hospital	Sapporo shi	Hokkaido	Japan	060-8570
9	Higashi Sapporo Neurology and Neurosurgery Clinic	Sapporo-shi	Hokkaido	Japan	003-0003
10	Konan Medical Center	Kobe shi	Hyogo	Japan	658-0064
11	Nishinomiya Municipal Central Hospital	Nishinomiya-shi	Hyogo	Japan	663-8014
12	Mito Kyodo General Hospital	Mito-shi	Ibaraki	Japan	310-0015
13	Kijima Neurosurgery Clinic	Kahoku-gun	Ishikawa	Japan	929-0342
14	Iwate Medical University Uchimaru Medical Center	Morioka-shi	Iwate	Japan	020-8505
15	Atsuchi Neurosurgery Hospital	Kagoshima-shi	Kagoshima	Japan	892-0842
16	Tanaka neurosurgical clinic	Kagoshima-shi	Kagoshima	Japan	892-0844
17	Fujitsu Clinic	Kawasaki-shi	Kanagawa	Japan	211-8588
18	St. Marianna University Hospital	Kawasaki-shi	Kanagawa	Japan	216-8511
19	Atago Hospital	Kochi-shi	Kochi	Japan	780-0051
20	Umenotsuji Clinic	Kochi-shi	Kochi	Japan	780-8011
21	Tatsuoka Neurology Clinic	Kyoto-shi	Kyoto	Japan	600-8811
22	Sendai Headache and Neurology Clinic, Medical Corporation	Sendai-shi	Miyagi	Japan	982-0014
23	Medical corporation oblige Ooba Clinic for Neurosurgery & Headache	Oita-shi	Oita	Japan	870-0831
24	Makabe Clinic	Okayama-shi	Okayama	Japan	700-0964
25	Okayama City General Medical Center Okayama City Hospital	Okayama-shi	Okayama	Japan	700-8557
26	Kitano Hospital,Tazuke Kofukai Medical Research Institute	Osaka-shi	Osaka	Japan	530-8480
27	Tominaga Clinic	Osaka-shi	Osaka	Japan	556-0015
28	Kindai University Hospital	Osakasayama-shi	Osaka	Japan	589-8511
29	Takase Internal Medicine Clinic	Toyonaka-shi	Oska	Japan	560-0012
30	Saitama Medical University Hospital	Iruma-gun	Saitama	Japan	350-0495
31	Saitama Neuropsychiatric Institute	Saitama-shi	Saitama	Japan	338-8577
32	Japanese Red Cross Shizuoka Hospital	Shizuoka-shi	Shizuoka	Japan	420-0853
33	Dokkyo Medical University Hospital	Shimotsuga-gun	Tochigi	Japan	321-0293
34	Juntendo University Hospital	Bunkyō-Ku	Tokyo	Japan	113-8431
35	Tokai university hachioji hospital	Hachioji-shi	Tokyo	Japan	192-0032
36	Shinagawa Strings Clinic	Minato-Ku	Tokyo	Japan	108-0075
37	Kitasato University Kitasato Institute Hospital	Minato-Ku	Tokyo	Japan	108-8642
38	USUDA CLINIC for internal medicine	Setagaya-Ku	Tokyo	Japan	156-0043
39	Fukuuchi Pain Clinic	Shinjuku-Ku	Tokyo	Japan	160-0017
40	Keio University Hospital	Shinjuku-Ku	Tokyo	Japan	160-8582
41	Nishiogi Pain Clinic	Suginami-Ku	Tokyo	Japan	167-0054
42	Sakura Clinic	Toyama-shi	Toyama	Japan	930-0803
43	Nagamitsu Clinic	Hofu-shi	Yamaguchi	Japan	747-0802
44	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: NCT05399459
• Other Study ID Numbers: BHV3000-313
• 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; Acute Migraine
• Additional relevant MeSH terms: Migraine Disorders

Study Results

No Results Posted as of Aug 17, 2022