Ubrogepant for Pediatric Migraine

(UBRO PEDS OLE Trial)

Enrolling by invitation at 163 trial locations

Overseen By ABBVIE CALL CENTER

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Allergan

Must not be taking: Barbiturates

Disqualifiers: ECG abnormalities, Self-harm risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 54 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and tolerability of ubrogepant for children with migraines. Ubrogepant is already used by adults for quick migraine relief, and researchers aim to determine its effectiveness in children. Children aged 6-17 years with migraines who have participated in a related study can join. Participants may take ubrogepant tablets to manage up to eight migraine attacks each month, with an option for a second dose if needed. Regular check-ups will monitor any side effects or health changes. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to important research that could lead to a new treatment option for children with migraines.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications that are on the list of prohibited drugs, like barbiturates, unless you can switch to an allowed alternative. If your current medication is not on the prohibited list, you may not need to stop taking it.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that ubrogepant is generally well-tolerated in both adults and children. Past studies have demonstrated a good safety record. The FDA has approved it for treating migraines in adults, which supports its safety.

For children, research suggests it is safe as well. One study with participants aged 6 to 17 found that most could take the drug without major problems. Some might experience mild side effects like nausea or tiredness, but these are uncommon.

Overall, evidence indicates that ubrogepant is safe for treating migraines in children and teens. Medical teams will monitor for any side effects during the study to ensure participants' safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for migraine?

Ubrogepant is unique because it targets migraine attacks by blocking the CGRP receptor, which plays a key role in migraine development. Unlike traditional treatments like triptans, which can cause vascular side effects, ubrogepant offers a non-vasoconstrictive option that could be safer for young patients. Researchers are excited about ubrogepant because it is an oral treatment that can provide relief without the cardiovascular risks associated with other migraine medications, making it a promising option for children and teenagers suffering from migraines.

What evidence suggests that ubrogepant might be an effective treatment for pediatric migraine?

Research has shown that ubrogepant effectively treats migraines. In studies, it significantly improved pain relief and reduced bothersome symptoms within two hours of administration. For adults, it helps many become pain-free. While specific data for children is still being gathered, this trial will evaluate two different doses of ubrogepant for pediatric participants: Dose A for ages 12 to 17 and Dose B for ages 6 to 11. The treatment is approved for adults, suggesting it could also work well for younger individuals. Ubrogepant blocks a protein in the brain called CGRP, which is involved in causing migraine pain. ^{1 3 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Completers of the lead-in Study 3110-305-002 (in the main study or PK cohort) or those who screen failed due to being placebo responders

Demonstrated an acceptable degree of compliance with study procedures in the lead-in study and who, in the investigator's clinical judgment, did not experience an AE that may indicate an unacceptable safety risk for this study

Exclusion Criteria

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

An ECG with clinically significant abnormalities at Visit 1 as determined by the investigator

Clinically significant abnormalities in physical examination at Visit 1, as determined by the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral ubrogepant tablets to treat up to 8 migraine attacks per month, with an option for a second dose or rescue medication

54 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue to receive ubrogepant to evaluate long-term safety and tolerability

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Ubrogepant

Trial Overview

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.

How Is the Trial Designed?

Group I: Ubrogepant Dose B (6 to 11 Years Old) Experimental Treatment 1 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 Treatment 1 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.

Ubrogepant is already approved in United States for the following indications:

Approved in United States as Ubrogepant for:

• Acute treatment of migraine in adults

Who Is Running the Clinical Trial?

Allergan

Lead Sponsor

Trials

782

Recruited

277,000+

Brent Saunders

Allergan

Chief Executive Officer since 2015

JD and MBA from Temple University

Dr. David Nicholson

Allergan

Chief Medical Officer since 2015

MD from Harvard Medical School

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

In a 52-week trial involving 1230 participants, ubrogepant (50 mg and 100 mg) was found to be safe and well-tolerated for the acute treatment of migraines, with low rates of treatment-related adverse events (10% for 50 mg and 11% for 100 mg).

The most common side effect was upper respiratory tract infection, and there were no serious liver-related issues, indicating that ubrogepant does not significantly impact liver function, which is crucial for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52-Week Extension Trial. Ailani, J., Lipton, RB., Hutchinson, S., et al.[2021]

Ubrogepant (Ubrelvy™) is a highly-selective CGRP antagonist that was approved in December 2019 for the acute treatment of migraines in adults, marking a significant advancement in migraine therapy.

As an orally administered medication, ubrogepant offers a new option for adults suffering from migraines, providing a targeted mechanism of action that specifically blocks the CGRP pathway involved in migraine attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant: First Approval. Scott, LJ.[2020]

In a Phase 3 clinical trial involving 1686 participants, ubrogepant demonstrated significantly greater efficacy than placebo for acute migraine treatment, with 21.8% of patients achieving pain freedom at 2 hours after taking the 50 mg dose.

Ubrogepant 50 mg also resulted in a higher rate of absence of the most bothersome migraine-associated symptom compared to placebo, indicating its potential effectiveness in alleviating multiple aspects of migraine attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Ubrogepant vs Placebo on Pain and the Most Bothersome Associated Symptom in the Acute Treatment of Migraine: The ACHIEVE II Randomized Clinical Trial. Lipton, RB., Dodick, DW., Ailani, J., et al.[2021]

In a phase 3 trial involving 518 participants, ubrogepant 100 mg significantly reduced the occurrence of moderate or severe headaches when taken during the prodrome phase of a migraine, with 46% of treated events showing improvement compared to 29% with placebo (p<0.0001).

Ubrogepant was found to be well tolerated, with a slightly higher incidence of adverse events (17%) compared to placebo (12%), indicating it is a safe option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Dodick, DW., Goadsby, PJ., Schwedt, TJ., et al.[2023]

A comprehensive analysis of 2,067 reports from the FDA Adverse Event Reporting System revealed that Ubrogepant, used for treating acute migraines, is associated with various adverse events, including nausea, dizziness, and new reports of hemiparesis and mental impairment.

The study highlights the importance of monitoring Ubrogepant's long-term safety, as it identified new adverse events not previously documented in clinical trials, enhancing our understanding of its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Ubrogepant-related adverse events using the FDA adverse event reporting system. Cao, B., Gu, S., Shen, Z., et al.[2023]

In a pooled analysis of 2,247 participants from the ACHIEVE I and II trials, ubrogepant demonstrated similar efficacy in treating acute migraine regardless of whether participants were using preventive medications, indicating it is effective for both groups.

The safety profile of ubrogepant was also consistent, with no significant differences in treatment-emergent adverse events between those on preventive treatments and those not, suggesting it is a safe option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials. Blumenfeld, AM., Knievel, K., Manack Adams, A., et al.[2022]

Ubrogepant significantly improves pain freedom and reduces bothersome migraine symptoms within 2 hours compared to placebo, with 20.8% of patients achieving pain freedom versus 12.6% for placebo in a meta-analysis of three trials involving 3326 patients.

Short-term use of ubrogepant does not increase the risk of treatment-related adverse events compared to placebo, indicating it is a safe option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ubrogepant for the Acute Treatment of Episodic Migraine: A Meta-Analysis of Randomized Clinical Trials. Yang, Y., Chen, M., Sun, Y., et al.[2021]

Ubrogepant, a calcitonin gene-related peptide receptor antagonist, has been shown to be significantly more effective than placebo in providing relief from migraine pain within 2 hours, with odds ratios indicating strong efficacy at both 50 mg and 100 mg doses.

This medication is a safe and effective alternative for patients who cannot tolerate traditional migraine treatments like NSAIDs or triptans, making it an important option for those with limited treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant: An Oral Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist for Abortive Migraine Treatment. Nedd, M., Garland, S., Falk, N., et al.[2022]

In a pooled analysis of 2240 participants from two phase 3 trials, ubrogepant 50 mg demonstrated significant efficacy in achieving pain freedom at 2 hours post-dose, with 20.5% of participants reporting this compared to 13.0% in the placebo group (P < 0.001).

Ubrogepant also showed a favorable safety profile, with similar rates of adverse events (11.5% for placebo vs. 11.2% for ubrogepant), and no serious adverse events related to treatment were reported, indicating it is a well-tolerated option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant for the Acute Treatment of Migraine: Pooled Efficacy, Safety, and Tolerability From the ACHIEVE I and ACHIEVE II Phase 3 Randomized Trials. Hutchinson, S., Dodick, DW., Treppendahl, C., et al.[2023]

Ubrogepant, a CGRP receptor antagonist approved by the FDA, has been shown to be effective in providing pain relief from migraines, outperforming placebo in Phase III trials (ACHIEVE I and II) within 2 hours of administration.

The 52-week open label extension of these trials confirmed the safety of ubrogepant, although a real-world study indicated higher adverse event rates, highlighting the need for further research on its long-term safety and efficacy, especially when used with other CGRP therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant in the Acute Management of Migraine: A Narrative Review. Chiang, CC., VanderPluym, JH.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05125302

NCT05125302 | Study to Assess Adverse Events and ...

The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents. Ubrogepant is ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9031827/

Emerging Pharmacological Treatments for Migraine in the ...

There is evidence to support the efficacy of the use of ibuprofen, acetaminophen (in children and adolescents), and triptans (mainly in ...

3.

nature.com

nature.com/articles/s41591-025-03679-7

Ubrogepant for the treatment of migraine prodromal ...

Treatment with ubrogepant during the prodromal phase may ameliorate common prodromal symptoms, with improvements possibly as early as 1 h post-dose.

4.

withpower.com

withpower.com/trial/phase-3-migraine-disorders-10-2021-b5e92

Ubrogepant for Pediatric Migraine (Ubro Peds Trial)

Ubrogepant significantly improves pain freedom and reduces bothersome migraine symptoms within 2 hours compared to placebo, with 20.8% of patients achieving ...

5.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1813049

Ubrogepant for the Treatment of Migraine

The coprimary efficacy end points were freedom from pain at 2 hours after the initial dose of ubrogepant or placebo and absence of the most ...

6.

abbvieclinicaltrials.com

abbvieclinicaltrials.com/study/?id=3110-306-002

3110-306-002

Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17).

7.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/appletter/2019/211765Orig1s000ltr.pdf

Ubrelvy (ubrogepant) - accessdata.fda.gov

3769-2. A randomized, double-blind, placebo-controlled efficacy and safety study under PREA to evaluate two doses of Ubrelvy (high-dose and low- ...

8.

ohsu.edu

ohsu.edu/sites/default/files/2024-10/PED24-Fri-04-Greene-Headaches.pdf

What's New in Pediatric Migraine?

➢ Generally safe in children with young healthy vessels! OHSU. CPD. Page 20. 20. Pediatric Migraine: Acute ...