Atogepant for Pediatric Migraine

(Kaleidoscope Trial)

Enrolling by invitation at 130 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and long-term use of atogepant for children and teens with migraines. Migraines are intense headaches that may include nausea or sensitivity to light and sound. Atogepant is already used by adults to treat migraines, and researchers aim to determine its effectiveness for children aged 6 to 17. Children who frequently experience migraines and participated in a previous study with this medicine might be suitable candidates. Participants will take the medicine daily and attend regular check-ups to monitor their progress. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for migraines in children and teens.

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.

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

Research has shown that atogepant is generally safe for treating migraines in adults and is already approved by the FDA for this purpose. Studies have found it to be well-tolerated, with constipation and nausea as the most common side effects, affecting about 7% of users. Serious side effects are rare.

This trial is in an advanced stage, indicating that earlier research found atogepant safe enough for broader testing. The current trial aims to confirm its safety for children aged 6 to 17. ^{1 2 3 4 5}

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

Researchers are excited about atogepant for pediatric migraine because it offers a new approach to preventing migraines in kids. Unlike most current treatments, which often involve pain relievers or triptans, atogepant works as a CGRP receptor antagonist, which means it blocks the receptor involved in triggering migraines. This novel mechanism of action is promising for reducing the frequency and severity of migraines. Additionally, atogepant is taken orally, which can be more convenient and less intimidating for children compared to injections.

What is the effectiveness track record for atogepant in treating migraines?

Research has shown that atogepant can reduce the number of migraine days. In adults, up to 87% of patients experienced fewer headache days after three months. Taking atogepant orally once a day has effectively reduced both migraine and headache days over 12 weeks. While most studies focus on adults, this trial will evaluate its effectiveness in children. Participants aged 12-17 will receive Atogepant Dose A, and those aged 6-11 will receive Atogepant Dose B. Early results suggest it may also help those aged 12 to 17. This treatment blocks certain proteins in the body linked to migraine pain, offering a promising option for better migraine management. ^{3 4 5 6 7}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39335375/

Effectiveness and Tolerability of Anti-Calcitonin Gene ... Significant reductions in headache days were observed in 82.6% of patients after one month and 87% after three months, with nearly 40% ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2035908

Atogepant for the Preventive Treatment of Migraine Oral atogepant once daily was effective in reducing the number of migraine days and headache days over a period of 12 weeks. Adverse events included ...

3. withpower.com withpower.com/trial/phase-3-migraine-disorders-2-2023-e7cbc

Atogepant for Pediatric Migraine (Kaleidoscope Trial) Rizatriptan significantly improved pain freedom in children and adolescents aged 12-17 years with migraines, with 30.6% of those treated achieving pain relief ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06810505

NCT06810505 | A Study of Oral Atogepant Tablets to ... A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years · Study ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1468961/full

Atogepant for migraine prevention: a meta-analysis of ... This systematic review and meta-analysis compared the safety and effectiveness of atogepant with placebo in treating migraine.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05707949

NCT05707949 | Long-term Extension Study to Assess ... 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 ...

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 QULIPTA ...