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 dry mouth. Triptans may lead to side effects such as dizziness, chest tightness, and fatigue. NSAIDs can cause gastrointestinal issues like stomach pain and ulcers. Ergotamines may result in nausea, vomiting, and potential cardiovascular side effects. It is important to discuss these options and their side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for migraine, including CGRP receptor antagonists like rimegepant. Rimegepant, marketed as Nurtec ODT, is used for the acute treatment of migraine and was approved in 2020. Other CGRP receptor antagonists include ubrogepant (Ubrelvy), approved in 2019, and atogepant (Qulipta), approved in 2021 for preventive treatment. Additionally, monoclonal antibodies targeting the CGRP pathway, such as erenumab (Aimovig), fremanezumab (Ajovy), and galcanezumab (Emgality), have been approved for migraine prevention. These treatments represent a significant advancement in migraine management by specifically targeting the CGRP pathway.

What other types of research exist?

Promising alternatives to Rimegepant for migraine treatment in 2024 include Ubrogepant, another CGRP receptor antagonist shown to be effective and well-tolerated in clinical trials. Additionally, monoclonal antibodies targeting CGRP, such as Erenumab, Galcanezumab, and Eptinezumab, have demonstrated efficacy and safety in both episodic and chronic migraine prevention. These treatments offer new options for patients who may not respond to or tolerate Rimegepant.

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Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist

Rimegepant for Pediatric Migraine

Q: What is the mechanism of action of this treatment?

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. By inhibiting this pathway, these drugs can reduce the frequency and severity of migraines. Triptans, another common treatment, activate serotonin (5-HT1B/1D) receptors, leading to the constriction of blood vessels and inhibition of inflammatory neuropeptides, providing relief from acute migraine attacks. NSAIDs and acetaminophen work by inhibiting the production of prostaglandins, which are chemicals that promote inflammation, pain, and fever. Understanding these mechanisms helps patients and healthcare providers choose the most appropriate treatment based on the specific pathways involved in their migraine attacks.

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

Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday before enrollment into the study)

1 or more migraine days requiring treatment during the Observation Phase

Must not have

History of cluster headache or hemiplegic migraine headache

Confounding and clinically significant pain syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 58 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to test the safety of rimegepant, a medication for treating migraines. The study focuses on children and adolescents aged 6 to 17 years who experience moderate to severe migraines. Rimegepant works by blocking a protein that triggers migraine pain, helping to alleviate symptoms.

Who is the study for?

This trial is for children and teens aged 6 to under 18 with a history of migraines, weighing at least 40 kg. They should have experienced 1-8 moderate or severe migraine attacks per month in the last two months and be able to tell migraines apart from other headaches. Stable use of preventive migraine medication is allowed.

What is being tested?

The study tests the long-term safety of Rimegepant (BHV3000) for treating acute, moderate or severe migraines in young participants. It aims to understand how well they tolerate this medication over an extended period.

What are the potential side effects?

While not specified here, common side effects may include nausea, drowsiness, dry mouth, and potential allergic reactions. Long-term studies like this one help identify any additional risks associated with prolonged use.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 6 and 17 years old.

Select...

I needed treatment for a migraine at least once during the observation period.

Select...

I've had 1-8 severe attacks a month in the last 2 months.

Select...

I've had 1-8 severe attacks a month in the last 2 months.

Select...

I weigh at least 40 kg.

Select...

I weigh at least 40 kg.

Exclusion Criteria

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

Select...

I have a history of cluster or hemiplegic migraine headaches.

Select...

I have severe pain that affects my daily life.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 58 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~58 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 58 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

The occurrence of treatment-emergent adverse events, serious adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Rimegepant / BHV3000Experimental Treatment1 Intervention

BHV3000 (rimegepant) 75 mg or 50 mg ODT

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. 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. By inhibiting this pathway, these drugs can reduce the frequency and severity of migraines. Triptans, another common treatment, activate serotonin (5-HT1B/1D) receptors, leading to the constriction of blood vessels and inhibition of inflammatory neuropeptides, providing relief from acute migraine attacks. NSAIDs and acetaminophen work by inhibiting the production of prostaglandins, which are chemicals that promote inflammation, pain, and fever. Understanding these mechanisms helps patients and healthcare providers choose the most appropriate 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.