Atogepant for Pediatric Migraine

(Kaleidoscope Trial)

Recruiting at 116 trial locations

Overseen By ABBVIE CALL CENTER

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must be taking: Atogepant

Disqualifiers: Persistent headache, 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: 3

Duration: 52 weeks

650 Participants Needed

Trial Summary

What is the purpose of this trial?

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for participants less than 18 years of age. The main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with migraine. Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of migraine. This is a Phase 3, open-label study of atogepant in participants with a history of migraine. Participants must have completed participation in another study of atogepant (lead-in study). Participants must have 4 to 14 migraine days and less than 15 headache days for episodic migraine, and \>= 15 headache days and \>= 8 migraine days for chronic migraine in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 650 participants will be enrolled in the study at approximately 100 sites worldwide. Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and 17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 52 Weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

Do I need to stop my current medications to join the trial?

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.

What data supports the effectiveness of the drug Atogepant (Qulipta) for pediatric migraine?

While there is limited direct evidence for Atogepant in children, similar treatments like CGRP pathway inhibitors have shown promise in adults and are being explored for pediatric use. The eagerness to evaluate adult migraine treatments in children suggests potential benefits, but more research is needed. ^{1 2 3 4 5}

Is atogepant safe for humans?

Atogepant has been studied for long-term safety in adults with migraine, and it is generally considered safe for this use. It is approved by the FDA for preventing migraines in adults, and studies have focused on its safety and tolerability over extended periods. ^{6 7 8 9 10}

How is the drug Atogepant unique for treating pediatric migraine?

Atogepant is unique because it is an oral medication specifically designed to prevent migraines by blocking the calcitonin gene-related peptide (CGRP) receptor, which is different from many other migraine treatments that may focus on relieving symptoms after they start. ^{6 8 10 11 12}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for kids aged 6-17 with episodic migraines, weighing between 44 and 298 lbs. They must have had migraines for at least six months and experience them on 4 to14 days per month. Participants should have finished a prior study or its screening phase but not met the migraine day count required there.

Inclusion Criteria

I have had migraines for at least 6 months.

I am between 6 and 17 years old and have a history of migraine attacks.

Participant must have completed specific study requirements or screening criteria

Exclusion Criteria

I have been diagnosed with a specific type of migraine.

I have been diagnosed with chronic migraine or a specific headache disorder.

I have a serious health condition affecting my blood, hormones, lungs, kidneys, liver, stomach, heart, or nervous system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive atogepant tablets once a day for 52 weeks

52 weeks

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Open-label extension

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

Long-term

Treatment Details

Interventions

• Atogepant

Trial Overview The trial tests Atogepant's long-term safety in children with migraines. It's an open-label Phase 3 study where participants take Atogepant daily for a year. The dosage varies by age: high dose for ages 12-17, and a specific dose determined earlier for ages 6-11.

Participant Groups

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

Participants aged 6-11 will receive the highest dose of oral tablets of atogepant tested in the lead-in study M21-201.

Group II: Atogepant Dose A (12-17 yrs) Experimental Treatment 1 Intervention

Participant aged 12-17 will receive oral tablets of atogepant Dose A once a day for up to 52 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

Findings from Research

Migraine is a prevalent issue among children and adolescents, leading to significant disability, yet there are limited evidence-based treatment options compared to adults.

This review highlights the need for evaluating newer migraine therapies, such as onabotulinumtoxinA and CGRP monoclonal antibodies, in pediatric populations, as current treatments do not work for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond the Guidelines: A Narrative Review of Treatments on the Horizon for Migraine in Children and Adolescents. VanderPluym, JH., Victorio, MCC., Oakley, CB., et al.[2023]

Rizatriptan significantly improved pain freedom in children and adolescents aged 12-17 years with migraines, with 30.6% of those treated achieving pain relief compared to 22.0% in the placebo group, indicating its efficacy as an acute treatment option.

The safety profile of rizatriptan was comparable to placebo, with similar rates of adverse events reported within 14 days, suggesting it is generally well tolerated in the pediatric population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of rizatriptan in pediatric migraineurs: results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design. Ho, TW., Pearlman, E., Lewis, D., et al.[2012]

Acute treatment options for pediatric migraines, such as ibuprofen, acetaminophen, and nasal sprays of sumatriptan and zolmitriptan, have been shown to be both safe and effective in controlled trials.

For preventive treatment, flunarizine has the best efficacy profile, although it is not available in the U.S., while other medications like topiramate and amitriptyline are being explored for their effectiveness in reducing migraine frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacological treatment options for pediatric migraine: an evidence-based appraisal. Lewis, DW., Winner, P.[2018]

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]

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]

In a 40-week study involving 685 participants, atogepant, an oral medication for preventing episodic migraines, demonstrated a long-term safety profile with 74.6% of participants completing the treatment.

While 62.5% of participants experienced treatment-emergent adverse events, most were mild, and serious adverse events were rare (3.4%), indicating that atogepant is well tolerated for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability results of atogepant for the preventive treatment of episodic migraine from a 40-week, open-label multicenter extension of the phase 3 ADVANCE trial. Klein, BC., Miceli, R., Severt, L., et al.[2023]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Beyond the Guidelines: A Narrative Review of Treatments on the Horizon for Migraine in Children and Adolescents. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of rizatriptan in pediatric migraineurs: results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

The pharmacological treatment options for pediatric migraine: an evidence-based appraisal. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Emerging Pharmacological Treatments for Migraine in the Pediatric Population. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Intranasal sumatriptan for the acute treatment of migraine in children. [2019]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Atogepant: First Approval. [2022]

7. United States 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability results of atogepant for the preventive treatment of episodic migraine from a 40-week, open-label multicenter extension of the phase 3 ADVANCE trial. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Atogepant for the prevention of episodic migraine in adults. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Atogepant for the Preventive Treatment of Migraine. [2021]

11. England 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. [2020]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluation of the Pharmacokinetic Interaction and Safety of Atogepant Co-Administered with Acetaminophen or Naproxen in Healthy Participants: A Randomized Trial. [2021]