What side effects are associated with this type of intervention?

Common treatments for migraine include CGRP receptor antagonists like Ubrogepant, triptans (e.g., sumatriptan, zolmitriptan), NSAIDs, and anticonvulsants. CGRP receptor antagonists are generally well-tolerated but can cause nausea, dry mouth, and fatigue. Triptans may lead to side effects such as dizziness, chest tightness, and tingling sensations. NSAIDs can cause gastrointestinal issues like stomach pain and ulcers, while anticonvulsants may result in weight changes, cognitive disturbances, and fatigue.

What prior FDA approvals exist?

The FDA has approved several treatments for migraine, including CGRP receptor antagonists like Ubrogepant. Ubrogepant itself is approved for the acute treatment of migraine in adults. Other similar drugs include Rimegepant, another CGRP receptor antagonist, which is also approved for acute migraine treatment. Additionally, monoclonal antibodies targeting the CGRP pathway, such as Erenumab, Fremanezumab, and Galcanezumab, have been approved for preventive treatment of migraine. These treatments represent significant advancements in migraine management by specifically targeting the CGRP pathway.

What other types of research exist?

Promising novel alternatives to Ubrogepant for migraine treatment in 2024 include: 1) Erenumab, a CGRP monoclonal antibody, which has shown efficacy in patients with prior preventive treatment failures. 2) Fremanezumab, another CGRP monoclonal antibody, effective in patients with documented failure of up to four preventive medication classes. 3) Galcanezumab, also a CGRP monoclonal antibody, which has demonstrated benefits in patients who did not respond to commonly prescribed preventive treatments. These alternatives offer new mechanisms of action and have been validated in recent clinical trials.

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Calcitonin Gene-Related Peptide (CGRP) Antagonist

Ubrogepant for Pediatric Migraine

Phase 3

Waitlist Available

Research Sponsored by Allergan

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Must not have

Requirement for any medication (eg, barbiturates) or diet (eg, grapefruit juice) that is on the list of prohibited concomitant medications that cannot be discontinued or switched to an allowable, alternative medication at Visit 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 54 weeks

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests the safety and effectiveness of ubrogepant, a quick-relief migraine medication, in children aged 6-17 years. Ubrogepant works by blocking a protein that causes migraine pain. The study will involve regular check-ups over several months to ensure the treatment is safe and well-tolerated. Ubrogepant is an oral medication approved for the acute treatment of migraine in adults.

Who is the study for?

This trial is for kids aged 6-17 with migraines who were in a previous study or got placebo. They must have followed the earlier study's rules and not had bad side effects. Kids can't join if they take certain meds, like barbiturates, eat grapefruit, have serious health issues, are at risk of self-harm, or might not stick to the study plan.

What is being tested?

The trial tests Ubrogepant tablets for treating migraines in kids. It checks how safe and tolerable it is over up to 54 weeks. Participants can treat up to 8 migraines a month with an option for a second dose after two hours or other rescue meds.

What are the potential side effects?

Possible side effects aren't detailed here but will be monitored through medical exams, blood tests, tracking adverse events (like unexpected symptoms), and questionnaires about how participants feel during treatment.

Eligibility Criteria

Exclusion Criteria

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

Select...

I can stop or switch any medication or diet that is not allowed in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 54 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 54 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 54 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 Behavior Rating Inventory of Executive Function (BRIEF 2) questionnaire

Change from baseline in Tanner staging score

Percentage of Participants with Adverse Events (AEs)

+5 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.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Ubrogepant Dose B (6 to 11 Years Old)Experimental Treatment1 Intervention

Participants will receive the highest dose of oral tablets of ubrogepant tested in Study 3110-305-002 for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, at least 2 hours after initial dose for headache of any intensity.

Group II: Ubrogepant Dose A (12 to 17 Years Old)Experimental Treatment1 Intervention

Participants will receive oral tablets of ubrogepant Dose A for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, at least 2 hours after initial dose for headache of any intensity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ubrogepant

2016

Completed Phase 4

~4990

0 / 1Eligibility 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 reduce the frequency of attacks. CGRP receptor antagonists, such as Ubrogepant, block the calcitonin gene-related peptide (CGRP) receptors, which play a crucial role in mediating pain and inflammation associated with migraines. By inhibiting these receptors, CGRP antagonists can effectively reduce migraine pain and prevent attacks. Triptans, another common treatment, activate serotonin (5-HT1B/1D) receptors, leading to the constriction of blood vessels and inhibition of pro-inflammatory neuropeptides, thus providing relief from migraine symptoms. NSAIDs, like ibuprofen and diclofenac, reduce inflammation and pain by inhibiting cyclooxygenase (COX) enzymes. Understanding these mechanisms helps migraine patients and their doctors choose the most appropriate treatment based on the specific pathways involved in their migraine attacks.

Calcitonin gene-related peptide receptor antagonists for migraine.