What side effects are associated with this type of intervention?

Common treatments for migraines include triptans (e.g., sumatriptan, zolmitriptan), NSAIDs (e.g., naproxen), and CGRP receptor antagonists like Ubrogepant. Triptans can cause side effects such as dizziness, fatigue, dry mouth, and, in rare cases, cardiovascular events. NSAIDs may lead to gastrointestinal issues, including stomach pain and ulcers. CGRP receptor antagonists, such as Ubrogepant, are generally well-tolerated but can cause nausea, dry mouth, and drowsiness. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment option.

What prior FDA approvals exist?

The FDA has approved several CGRP receptor antagonists for the treatment of migraine, similar to Ubrogepant. These include Erenumab (Aimovig), Fremanezumab (Ajovy), and Galcanezumab (Emgality), which are used for preventive treatment. Additionally, Rimegepant (Nurtec ODT) and Atogepant (Qulipta) have been approved for acute and preventive treatment of migraine. These drugs work by blocking the calcitonin gene-related peptide (CGRP) receptor, which plays a key role in migraine pathophysiology. Other common treatments for migraine include triptans, NSAIDs, and combination medications like sumatriptan-naproxen.

What other types of research exist?

Promising novel alternatives to Ubrogepant for migraine treatment in 2024 include CGRP monoclonal antibodies such as Erenumab, Fremanezumab, and Galcanezumab. These have shown efficacy in preventing migraines in patients who have not responded to other treatments. Additionally, Lasmiditan, a serotonin (5-HT1F) receptor agonist, is another novel option for acute migraine treatment.

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Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist

Ubrogepant for Pediatric Migraine (Ubro Peds Trial)

Verified Trial

Phase 3

Recruiting

Research Sponsored by Allergan

Eligibility Criteria Checklist

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

Must have

Do you child’s migraines last between 3-72 hours if untreated?

Has your child had migraines for at least 6 months?

Must not have

History of 1 to 14 migraine attacks per month with moderate to severe headache in each of the 2 months prior to screening (Visit 1).

Timeline

Screening 3 days

Treatment Varies

Follow Up 3 days

Awards & highlights

Pivotal Trial

Summary

This trial will test if ubrogepant is safe and effective for young people with migraines. Ubrogepant is a medication taken by mouth to treat migraine headaches. It works by blocking a protein in the brain that causes migraine pain. The study focuses on children and adolescents who suffer from migraines.

Who is the study for?

This trial is for children and adolescents aged 6-17 with a history of migraines, experiencing 1-14 attacks per month. They must have tried at least one oral migraine medication and their migraines should last between 3-72 hours if untreated. Exclusions include drug abuse, certain gastrointestinal conditions, specific types of migraines like hemiplegic or retinal, significant neurological disorders other than migraine, frequent hospital treatments for migraines, suicide risk, hypersensitivity to CGRP receptor antagonists or any study components.

What is being tested?

The trial tests the safety and effectiveness of Ubrogepant—an approved adult migraine treatment—in young patients during acute migraine episodes. Participants will be split into two age groups (6-11 and 12-17) and randomly assigned to receive either a low or high dose of Ubrogepant or a placebo in a double-blind manner. There's a chance they'll get the placebo instead of the actual drug.

What are the potential side effects?

While not specified here, common side effects from similar medications may include nausea, dry mouth, drowsiness, fatigue and potential allergic reactions. The exact side effects related to Ubrogepant in this age group will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

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

Select...

My child's migraines last from 3 to 72 hours without treatment.

Select...

My child has had migraines for at least 6 months.

Select...

I have tried at least one over-the-counter oral medication for my child's migraines.

Select...

My child experiences 1-14 migraine attacks monthly.

Exclusion Criteria

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

Select...

I have had 1 to 14 moderate to severe migraines each month for the last 2 months.

Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ 3 days1 visit

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years

Secondary study objectives

Change From Baseline in Electrocardiograms (ECGs) in pediatric participants aged 6 to 17 years

Number of Participants with Adverse Events (AE)

Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose in pediatric participants aged 12 to 17 years

+10 more

Side effects data

From 2023 Phase 4 trial • 263 Patients • NCT05264129

COVID-19

DECREASED APPETITE

NAUSEA

FATIGUE

CONSTIPATION

100%

80%

60%

40%

20%

Study treatment Arm

Atogepant 60 mg (Period 1)

Atogepant 60 mg + Ubrogepant 100 mg (Period 2)

Awards & Highlights

Pivotal Trial

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

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: PK Cohort: Ubrogepant Dose BExperimental Treatment1 Intervention

Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.

Group II: PK Cohort: Ubrogepant Dose AExperimental Treatment1 Intervention

Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.

Group III: Main Study: Children Ubrogepant Low DoseExperimental Treatment1 Intervention

Participants aged 6 to 11 (after dose selection) will receive oral tablets of low dose ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Group IV: Main Study: Children Ubrogepant High DoseExperimental Treatment1 Intervention

Participants aged 6 to 11 (after dose selection) will receive oral tablets of high dose ubrogepant Dose B for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Group V: Main Study: Adolescents Ubrogepant Low DoseExperimental Treatment1 Intervention

Participants aged 12 to 17 will receive oral tablets of ubrogepant low dose for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Group VI: Main Study: Adolescents Ubrogepant High DoseExperimental Treatment1 Intervention

Participants aged 12 to 17 will receive oral tablets of ubrogepant high dose or qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Group VII: Main Study: Children Ubrogepant PlaceboPlacebo Group1 Intervention

Participants aged 6 to 11 (after dose selection) will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Group VIII: Main Study: Adolescents Ubrogepant PlaceboPlacebo Group1 Intervention

Participants aged 12 to 17 will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ubrogepant

2016

Completed Phase 4

~4990

0 / 5Eligibility 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 Ubrogepant, block the CGRP receptors involved in pain transmission and inflammation, providing relief from migraine attacks. Triptans, another common class, activate 5-HT(1B/1D) receptors to constrict blood vessels and inhibit pain pathways. NSAIDs and acetaminophen reduce inflammation and pain by inhibiting cyclooxygenase enzymes. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the specific pathways involved in their migraine, potentially improving outcomes and reducing the frequency and severity of attacks.

Calcitonin gene-related peptide receptor antagonists for migraine.