What side effects are associated with this type of intervention?

Common treatments for migraines include CGRP receptor antagonists like Rimegepant, triptans, NSAIDs, and anticonvulsants. CGRP receptor antagonists, such as Rimegepant, are generally well-tolerated but can cause side effects like nausea and urinary tract infections. Triptans may cause dizziness, chest tightness, and fatigue. NSAIDs can lead to gastrointestinal issues, including stomach pain and ulcers. Anticonvulsants like topiramate may result in weight loss, cognitive disturbances, and tingling in the extremities.

What prior FDA approvals exist?

The FDA has approved several treatments for migraine, including CGRP receptor antagonists like Rimegepant. Other CGRP receptor antagonists that have received FDA approval include Erenumab (Aimovig), Fremanezumab (Ajovy), and Galcanezumab (Emgality). These drugs work by blocking the calcitonin gene-related peptide (CGRP) pathway, which is involved in migraine pathophysiology. Additionally, triptans, such as Sumatriptan and Zolmitriptan, have been widely used for acute migraine treatment. These medications offer various options for patients, targeting different mechanisms involved in migraine attacks.

What other types of research exist?

Promising, novel alternatives to Rimegepant for migraine treatment in 2024 include ubrogepant, galcanezumab, eptinezumab, and erenumab. These treatments have demonstrated efficacy and safety in recent clinical trials.

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Calcitonin Gene-Related Peptide (CGRP) Antagonist

Rimegepant for Migraine Prevention

Phase 4

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Migraine attacks, on average, lasting 4-72 hours if untreated

Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition

Must not have

Women with a positive pregnancy test at screening or prior to study drug administration

History of use of analgesics (e.g., non-steroidal anti-inflammatory drugs [NSAIDs] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months (12 weeks)

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing if taking rimegepant regularly can prevent occasional migraines by blocking a protein in the brain that triggers migraine pain. Rimegepant is a medication that is effective for migraine prevention.

Who is the study for?

This trial is for individuals who have had episodic migraines for at least a year, with onset before age 50. Participants should experience 4-14 migraine attacks per month and not be using any preventive migraine medication or certain painkillers frequently. Women must not be pregnant, breastfeeding, or planning to become pregnant without using contraception.

What is being tested?

The study aims to test the effectiveness and safety of Rimegepant in preventing episodic migraines when taken daily or every other day compared to a placebo (a substance with no active drug).

What are the potential side effects?

While specific side effects are not listed here, participants may experience adverse reactions related to Rimegepant which could include nausea, dizziness, fatigue, dry mouth and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My migraines last between 4 to 72 hours without treatment.

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I have had migraines for at least a year, as per the headache classification.

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I have had 4-14 migraine attacks each month for the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant.

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I have been taking painkillers like NSAIDs or acetaminophen almost every day for the last 3 months.

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I've used migraine medication for other reasons almost daily for the last 3 months.

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I am not pregnant or breastfeeding.

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I am not taking any medications that are not allowed in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months (12 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months (12 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months (12 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Secondary study objectives

Mean change from baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) restrictive role function.

Mean change from the Observation Phase

Mean change from the Observation Phase.

+5 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Rimegepant 75mg Orally Disitegrating Tablet (ODT)daily dosingExperimental Treatment1 Intervention

Double-blind Treatment Phase: Rimegepant 75 mg ODT dosed daily Open-Label Extension Phase: Rimegepant 75 mg ODT dosed daily

Group II: Rimegepant 75mg Orally Disintegrating Tablet (ODT)every other day dosingExperimental Treatment1 Intervention

Double-blind Treatment Phase: Rimegepant 75 mg ODT every other day dosing alternating with matching placebo

Group III: Placebo comparator dosingPlacebo Group1 Intervention

Double-blind Treatment Phase: matching placebo dosed daily

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Migraine treatments work through various mechanisms to alleviate symptoms and prevent attacks. Calcitonin gene-related peptide (CGRP) receptor antagonists, like Rimegepant, block the CGRP receptors, which are involved in mediating pain and inflammation in migraines. This helps reduce the frequency and severity of migraine attacks. Triptans, another common treatment, activate serotonin (5-HT1B/1D) receptors, leading to the constriction of blood vessels and inhibition of pro-inflammatory neuropeptides, providing acute relief from migraine pain. Ergotamines also target serotonin receptors but have a broader action on multiple receptor types, which can make them effective but with a higher risk of side effects. Understanding these mechanisms is crucial for migraine patients as it helps in selecting the most appropriate treatment based on their specific symptoms and medical history, potentially improving outcomes and reducing the burden of migraines.

The effect and safety of monoclonal antibodies to calcitonin gene-related peptide and its receptor on migraine: a systematic review and meta-analysis.Calcitonin gene-related peptide receptor antagonists for migraine.