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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Placebo; Drug: Rimegepant 75 MG; Drug: Rimegepant 25 MG

Study type: Interventional

Funder types: Industry

Identifiers

NCT05399459

BHV3000-313

C4951022 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 897 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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 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), hemiplegic migraine or retinal 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 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.
4. Uncontrolled hypertension or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to screening).
5. Subject with other pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments.
6. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has a disease that causes malabsorption.
7. The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or 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.
8. History of alcohol abuse and/or illicit drug use meeting DSM-V criteria for substance use disorder within 6 months of screening.
9. Participation in any other investigational clinical trial while participating in this clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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897 participants in 3 patient groups, including a placebo group

Rimegepant 25 mg

Experimental group

Description:

Single dose of 25 mg orally disintegrating tablet of rimegepant

Treatment:

Drug: Rimegepant 25 MG

Rimegepant 75 mg

Experimental group

Description:

Single dose of 75 mg orally disintegrating tablet of rimegepant

Treatment:

Drug: Rimegepant 75 MG

Placebo

Placebo Comparator group

Description:

Matching placebo tablet

Treatment:

Drug: Placebo