Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects

JRCT ID: jRCT2031220236

Registered date:02/08/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Migraine
• Date of first enrollment: 09/08/2022
• Target sample size: 795
• Study type: Interventional

Intervention(s)

Drug: Rimegepant 25 MG
Single dose of 25 mg orally disintegrating tablet of rimegepant
Other Name: BHV3000
Drug: Rimegepant 75 MG
Single dose of 75 mg orally disintegrating tablet of rimegepant
Other Name: BHV3000
Drug: Placebo
Matching placebo tablet

Outcome(s)

• Primary Outcome: Pain freedom at 2 hours post-dose [Time Frame: 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).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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 thisrequirement during the Screening period
6.Less than 15 days with headache (migraine or non-migraine) per month in each of the 3months prior to the Screening Visit and maintains this requirement during the ScreeningPeriod.
7.Subjects on one prophylactic migraine medication are permitted to remain on therapyprovided they have been on a stable dose for at least 3 months prior to screening visit andthe 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 allother study entry criteria

Exclude 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

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT05399459