Oral Atogepant Tablets for Migraine

(ATO EM PEDS Trial)

Recruiting at 136 trial locations

Overseen By ABBVIE CALL CENTER

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Chronic migraine, Cluster headache, 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: 1

Duration: 12 weeks

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called atogepant (also known as Qulipta) to evaluate its safety and effectiveness for children and teens with migraines. Migraines are severe headaches that may include symptoms like nausea and sensitivity to light. The study will compare the effects of low and high doses of atogepant to a placebo (a pill with no active ingredient) in participants aged 6 to 17. Children and teens who experience 4 to 14 migraine days a month might be suitable for this trial. Participants must visit a clinic regularly for check-ups and tests. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking migraine treatment for young people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that atogepant is generally safe for treating migraines in adults. Common side effects include nausea, constipation, and tiredness, occurring in at least 4% of people, and are more frequent than in those taking a placebo. One study found no major difference in side effects between those taking atogepant and those on a placebo, suggesting it is safe.

In a large study with 2,657 migraine patients, atogepant was well-tolerated. The safety results aligned with existing knowledge about the drug, and no new safety issues emerged. A long-term study also reported that about 79% of participants experienced treatment-related side effects. However, these were known side effects and were manageable.

The FDA has already approved atogepant for adults, supporting its safety. This trial aims to explore its use in children and teens, offering them a potentially safe treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about atogepant for migraines because it offers a new approach compared to traditional treatments. Most migraine medications, like triptans, work by targeting serotonin receptors, but atogepant is a CGRP receptor antagonist, which stops a protein involved in migraine pathways from triggering headaches. This makes it a promising option for those who don't respond well to existing treatments. Additionally, atogepant is an oral tablet, making it convenient and easy to take, potentially improving adherence for young patients.

What evidence suggests that atogepant could be an effective treatment for pediatric migraine?

Research has shown that atogepant can reduce the number of migraine days in adults. In one study, over 64% of adults taking atogepant experienced a reduction of at least half in their monthly migraine days. Another study found that it significantly lowered the number of headache days over 12 weeks compared to a placebo. This trial will test atogepant in children and teenagers aged 6 to 17, with different groups receiving either low or high doses of atogepant or a placebo. While the results in adults are promising, the goal is to confirm its effectiveness for ages 6 to 17. ^{2 6 7 8 9}

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 episodic migraines, weighing between 44 and 298 lbs. They must have had 4 to 14 migraine days in the past month but less than 15 headache days overall. It's not for those with certain other headaches or who've needed hospital treatment for migraines three times in six months.

Inclusion Criteria

I am between 6 to 11 years old and need preventive treatment for my migraines.

My weight is between 44 lbs and 298 lbs.

I experience 4 to 14 migraine days and less than 15 headache days in a month.

Exclusion Criteria

I have had specific severe migraines, as defined by a 2018 standard.

I have been diagnosed with a specific type of severe headache or facial pain.

I have been diagnosed with chronic migraines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive placebo, low-dose, or high-dose atogepant for 12 weeks

12 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Open-label extension

Participants may opt into continuation of atogepant treatment for long-term evaluation

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Atogepant
• Placebo-Matching Atogepant

Trial Overview

The study tests low and high doses of atogepant, a migraine medication approved for adults, now being studied in children. Participants are randomly assigned to receive either a placebo or atogepant daily for twelve weeks, with some continuing up to a year.

How Is the Trial Designed?

Group I: Open-Label PK Substudy: Atogepant Dose B (6-11 yrs) Experimental Treatment 1 Intervention

Participants aged 6 to 11 will receive oral tablets of atogepant Dose B to determine appropriate dose for the 6-11 year old group in double-blind treatment period.

Group II: Open-Label PK Substudy: Atogepant Dose A (6-11 yrs) Experimental Treatment 1 Intervention

Participants aged 6 to 11 will receive oral tablets of atogepant Dose A to determine appropriate dose for the 6-11 year old group in double-blind treatment period.

Group III: Double-Blind Treatment Period: Placebo (6-11 yrs) Experimental Treatment 1 Intervention

Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.

Group IV: Double-Blind Treatment Period: Placebo (12-17 yrs) Experimental Treatment 1 Intervention

Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.

Group V: Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs) Experimental Treatment 1 Intervention

Participants aged 6-11 will receive oral tablets of low dose atogepant once a day for 12 weeks.

Group VI: Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs) Experimental Treatment 1 Intervention

Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks.

Group VII: Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs) Experimental Treatment 1 Intervention

Participants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks.

Group VIII: Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs) Experimental Treatment 1 Intervention

Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks.

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

Approved in United States as Qulipta for:

• Preventive treatment of migraine in adults

Who Is Running the Clinical Trial?

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

Atogepant, a calcitonin gene-related peptide receptor antagonist, significantly reduced the number of monthly migraine days in participants compared to placebo, with reductions ranging from -3.1 to -4.4 days across different treatment periods over 12 weeks.

The treatment effects of atogepant were evident as early as the first day after starting the medication, with a lower percentage of participants experiencing migraines on the first post-dose day compared to those on placebo (10.8% to 14.1% vs. 25.2%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time course of efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind ADVANCE trial. Schwedt, TJ., Lipton, RB., Ailani, J., et al.[2022]

Atogepant (Qulipta™) is an oral medication that works as a CGRP receptor antagonist, specifically designed for preventing episodic migraines, and was approved in the USA in September 2021.

The drug is currently undergoing phase 3 clinical trials in other countries, indicating ongoing research and potential for broader use in migraine prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atogepant: First Approval. Deeks, ED.[2022]

Atogepant is an effective oral medication for preventing migraines, significantly reducing mean monthly migraine days in patients with episodic migraine over a 12-week period in placebo-controlled trials.

While atogepant offers a new alternative to injectable migraine treatments, it has potential side effects like nausea and constipation, and its high cost may limit its use to patients who prefer oral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atogepant for the prevention of episodic migraine in adults. Switzer, MP., Robinson, JE., Joyner, KR., et al.[2023]

In a 52-week trial involving 744 adults with migraine, daily oral atogepant 60 mg was found to be safe and well-tolerated, with 67% of participants experiencing treatment-emergent adverse events, mostly mild to moderate.

Atogepant significantly reduced the mean monthly migraine days, with 84.2% of participants achieving at least a 50% reduction in migraine frequency by the end of the study, demonstrating its efficacy as a preventive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-daily oral atogepant for the long-term preventive treatment of migraine: Findings from a multicenter, randomized, open-label, phase 3 trial. Ashina, M., Tepper, SJ., Reuter, U., et al.[2023]

Atogepant, an oral CGRP antagonist approved for migraine prevention, demonstrated significant efficacy in reducing monthly migraine days and was well tolerated in two randomized, double-blind trials involving 1,727 participants.

The most common side effects reported were nausea, constipation, and upper respiratory infections, indicating that while atogepant is effective, it does have some mild adverse effects that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atogepant for Migraine Prevention: A Systematic Review of Efficacy and Safety. Singh, A., Balasundaram, MK.[2022]

In a phase 3 trial involving 910 adults, atogepant significantly reduced the number of migraine days per month compared to placebo, with reductions of 3.7 to 4.2 days depending on the dosage over 12 weeks.

Common side effects of atogepant included constipation and nausea, but serious adverse events were rare, indicating a generally favorable safety profile; however, further long-term studies are needed to fully assess its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atogepant for the Preventive Treatment of Migraine. Ailani, J., Lipton, RB., Goadsby, PJ., et al.[2021]

In a phase 2b/3 trial involving 834 adults with a history of migraines, all doses of atogepant significantly reduced the number of monthly migraine days compared to placebo over a 12-week period, indicating its efficacy as a preventive treatment for migraines.

Atogepant was found to be safe and well tolerated, with the most common side effects being nausea and fatigue, and serious adverse events were not related to the treatment, supporting its further development for migraine prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial. Goadsby, PJ., Dodick, DW., Ailani, J., et al.[2020]

Citations

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Powerful Migraine Day Reductions

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The efficacy and safety of Atogepant for migraine prophylaxis

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AbbVie Announces New Data Demonstrating Atogepant ...

The study also met all six secondary endpoints, including a key measure of clinical efficacy: 64.1% of patients on atogepant achieved a ≥50% ...

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nejm.org

nejm.org/doi/full/10.1056/NEJMoa2035908

Atogepant for the Preventive Treatment of Migraine

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neurology.org

neurology.org/doi/10.1212/WNL.0000000000209584

Efficacy of Atogepant in Chronic Migraine With and Without ...

There was a 52.1%–61.9% reduction in the proportion of atogepant-treated participants meeting acute medication overuse criteria over 12 weeks.

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quliptahcp.com

quliptahcp.com/safety

Safety Studies - QULIPTA® (atogepant) HCP

The most common adverse reactions (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence.

7.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2025/215206s011lbl.pdf

QULIPTA® (atogepant) tablets, for oral use - accessdata.fda.gov

The safety of QULIPTA was evaluated in 2657 patients with migraine who received at least one dose of QULIPTA. Of these, 1225 patients were exposed to ...

8.

news.abbvie.com

news.abbvie.com/2024-04-12-AbbVie-Announces-Late-Breaking-Data-at-AAN-Supporting-Long-Term-Safety-and-Efficacy-of-Atogepant-QULIPTA-R-for-Preventive-Treatment-of-Migraine

AbbVie Announces Late-Breaking Data at AAN Supporting ...

Overall safety results were consistent with the known safety profile of atogepant 60 mg, and no new safety signals were identified.

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40831083/

Long-term safety, efficacy and functional outcomes of ...

In this interim analysis, mean duration of atogepant exposure was 496.5 days. Treatment-emergent adverse events (TEAEs) occurred in 79.0% of ...