Atogepant for Migraine

Recruiting at 61 trial locations

Overseen By ABBVIE CALL CENTER

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Hypertension, Cardiovascular, Neurologic, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

420 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests atogepant, a medication to prevent migraines, specifically for young people aged 12 to 17 who experience chronic migraines (frequent, severe headaches often with nausea or sensitivity to light and sound). Participants will receive either atogepant or a placebo (a pill with no active medicine) once a day for 12 weeks. The trial aims to assess atogepant's effectiveness in preventing migraines and to identify any side effects compared to the placebo. Ideal candidates have experienced migraines for at least six months and have had frequent headaches and migraines recently. Participants will keep a daily diary and attend regular check-ups to monitor the treatment's impact. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new migraine prevention treatment.

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 study team or your doctor.

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

Research has shown that atogepant is generally safe and well-tolerated. Studies have found that people taking atogepant experienced fewer migraine days and required less medication for quick pain relief. Some individuals did encounter side effects, but these aligned with known safety profiles.

Atogepant is already approved for preventing migraines in adults, indicating a proven safety record. In earlier studies, participants taking atogepant experienced a significant reduction in migraine days without major safety concerns. Overall, the evidence supports atogepant's safety for preventing migraines, which is promising for its potential use in younger individuals. ^{1 2 3 4 5}

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

Atogepant is unique because it offers a new approach to migraine prevention by targeting and blocking a specific receptor called the calcitonin gene-related peptide (CGRP) receptor. Unlike traditional treatments such as triptans, which primarily relieve symptoms of a migraine attack, atogepant is designed to prevent these attacks before they even start. Researchers are excited about atogepant because it has shown the potential for high efficacy with once-daily oral dosing, making it a convenient option for patients looking to reduce the frequency of their migraines.

What evidence suggests that atogepant might be an effective treatment for chronic migraine in adolescents?

Research has shown that atogepant, which participants in this trial may receive, effectively reduces the number of migraine days when taken once daily. Studies have found it significantly lowers the number of monthly migraine days compared to a placebo, with reductions ranging from 52.1% to 61.9% in participants. Atogepant is already approved for adults, indicating its proven effectiveness in preventing migraines. These results suggest it could also benefit younger people with chronic migraines. Overall, atogepant appears promising for reducing migraines and improving quality of life. ^{2 4 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 young people aged 12 to 17 with chronic migraine, experiencing at least 8 migraine days and a minimum of 15 headache days. They must have had migraines for at least six months and be able to complete an electronic diary regularly.

Inclusion Criteria

I have filled out the eDiary for at least 20 days in the last month.

I have been diagnosed with chronic migraines for at least 6 months.

I experience 15 or more headache days a month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral tablets of atogepant or placebo once daily 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

What Are the Treatments Tested in This Trial?

Interventions

• Atogepant

Trial Overview The study tests Atogepant tablets against a placebo in preventing migraines. It's double-blinded, so neither participants nor doctors know who gets the real medicine or placebo. The treatment lasts for 12 weeks with follow-up after four weeks.

How Is the Trial Designed?

Group I: Atogepant Experimental Treatment 1 Intervention

Participants will receive atogepant once daily for 12 weeks.

Group II: Placebo for Atogepant Placebo Group 1 Intervention

Participants will receive placebo for atogepant once daily for 12 weeks.

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 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]

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 with episodic migraine, atogepant (30 mg and 60 mg) significantly improved patient-reported outcomes, including quality of life and daily activity performance, compared to placebo over 12 weeks.

Atogepant demonstrated clinically meaningful improvements in the Migraine-Specific Quality-of-Life Questionnaire and Activity Impairment in Migraine-Diary scores, indicating its efficacy as a preventive treatment for migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Atogepant for Preventive Migraine Treatment on Patient-Reported Outcomes in the Randomized, Double-blind, Phase 3 ADVANCE Trial. Lipton, RB., Pozo-Rosich, P., Blumenfeld, AM., 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]

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]

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]

Atogepant is an oral medication that specifically targets the CGRP receptor, which plays a crucial role in the development of migraines, making it effective for preventing migraine attacks.

As a CGRP receptor antagonist, atogepant works by blocking the action of CGRP, a neuropeptide that contributes to migraine symptoms, thus providing a new option for individuals seeking preventive treatment for migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atogepant for migraine. Bedrin, K., Ailani, J.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40874574/

Effectiveness and tolerability of atogepant as preventive ... Primary outcomes included change in monthly migraine days (MMDs) and greater than 50% responder rate at 12 and 24 weeks. Secondary outcomes ...

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. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/s12883-025-04350-x

“The efficacy and safety of Atogepant for migraine prophylaxis ... Atogepant significantly reduces mean monthly migraine days compared to placebo across multiple dosage levels. Significant improvements were ...

4. 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. Atogepant ...

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

Long-term safety, efficacy and functional outcomes of ... ConclusionsOverall safety results were consistent with the known safety profile of atogepant and the drug was well-tolerated over the course of ...

7. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(24)00025-5/abstract

Safety and efficacy of atogepant for the preventive ... Atogepant 60 mg once a day was safe, well tolerated, and showed significant and clinically relevant reductions in mean monthly migraine days ...

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 ... Seventy percent of subjects achieved ≥50% reduction in monthly migraine days at Weeks 13-16 and this was consistent during the 48 weeks of open ...