What side effects are associated with this type of intervention?

Common treatments for migraines include CGRP receptor antagonists like Rimegepant, triptans, NSAIDs, and ergotamines. CGRP receptor antagonists are generally well-tolerated but can cause nausea and fatigue. Triptans, such as sumatriptan and zolmitriptan, may lead to side effects like taste disturbances, dizziness, and chest discomfort. NSAIDs, including ibuprofen and naproxen, can cause gastrointestinal issues such as stomach pain and ulcers. Ergotamines, like dihydroergotamine, may result in nausea, vomiting, and, in rare cases, ischemic complications.

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) receptor, which plays a key role in migraine pathophysiology. These treatments offer new options for patients who may not respond to traditional migraine therapies.

What other types of research exist?

Promising alternatives to Rimegepant for migraine treatment in 2024 include Ubrogepant, another CGRP receptor antagonist, which has shown efficacy and tolerability in clinical trials. Additionally, monoclonal antibodies targeting CGRP, such as Galcanezumab and Eptinezumab, have demonstrated effectiveness in both episodic and chronic migraine prevention. These treatments offer new options for patients seeking alternatives to Rimegepant.

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Rimegepant for Migraine Prevention in Children

Phase 3

Recruiting

Research Sponsored by Biohaven Pharmaceuticals, Inc.

Eligibility Criteria Checklist

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

Must have

14 or less headache days per month during the 3 month period prior to the Screening Visit

6 or more migraine days during the Observation Period

Must not have

Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine

The subject has a history or diagnosis of complications of migraine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months (12 weeks)

Awards & highlights

Pivotal Trial

Summary

This trial is testing rimegepant, a medication that prevents migraines, in children and teens who have occasional migraines. It works by blocking a protein that causes migraine pain. Rimegepant is taken orally and has shown effectiveness in treating migraines.

Who is the study for?

This trial is for children and adolescents aged 6 to under 18 who experience episodic migraines, with an average of 14 or fewer headache days per month. They must have a history of migraine lasting between 4-72 hours if untreated and weigh at least 15 kg (or ≥40 kg for certain cohorts). Participants can be on stable migraine medication.

What is being tested?

The study aims to determine the effectiveness and safety of Rimegepant compared to a placebo in preventing migraines in young people. It involves giving some participants the actual drug while others receive a placebo, without knowing which one they are taking.

What are the potential side effects?

While specific side effects are not listed here, Rimegepant may cause reactions that could include digestive issues, dizziness, dry mouth, fatigue or allergic responses. The severity and type of side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I've had 14 or fewer headache days each month for the last 3 months.

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I have had 6 or more migraine days recently.

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I had 14 or fewer headache days recently.

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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 6 months.

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I've had 14 or fewer headache days each month for the last 3 months.

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I have had 6 or more migraine days recently.

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I had 14 or fewer headache days recently.

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My migraines last between 4 to 72 hours without treatment.

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I am between 6 and 17 years old.

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I weigh at least 40 kg.

Exclusion Criteria

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

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I have a history of specific severe headaches.

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I have had complications due to my migraines.

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I have not had untreated psychiatric conditions in the last 6 months.

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

Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine

Secondary study objectives

Change from baseline on the proportion of subjects that have at least a 50% reduction in the mean number of moderate to severe migraine days per month.

Compare the use of acute migraine-specific medications (triptans) based on the change from baseline in monthly acute migraine specific medication days.

Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant.

+1 more

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Rimegepant / BHV3000Active Control1 Intervention

Rimegepant 75mg or 50mg (2 X 25mg) ODT

Group II: Matching PlaceboPlacebo Group1 Intervention

Matching placebo 75mg or 50mg (2 X 25mg) ODT

0 / 14Eligibility 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. CGRP receptor antagonists, such as Rimegepant, block the calcitonin gene-related peptide (CGRP) receptor, which is involved in the transmission of pain and the dilation of blood vessels during a migraine. Triptans, another common treatment, are serotonin (5-HT1B/1D) receptor agonists that constrict blood vessels and inhibit the release of inflammatory neuropeptides. NSAIDs and acetaminophen reduce inflammation and pain by inhibiting cyclooxygenase enzymes and blocking pain signals. Understanding these mechanisms helps migraine patients and their doctors choose the most effective treatment based on the specific pathways involved in their migraine attacks.

Prevention of migraine with monoclonal antibodies against CGRP or the CGRP receptor: Addition to the S1 guideline: Therapy of migraine attacks and prevention of migraine. Recommendations of the Germany Society of Neurology and the German Migraine and Headache Society.Calcitonin gene-related peptide receptor antagonists for migraine.