Atogepant for Migraine Prevention

Recruiting at 400 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Hypertension, Suicidal ideation, ECG abnormalities, 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: 156 weeks

596 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking some of your current medications if they are on the list of prohibited treatments for this trial. If your medication is not on the list, you might be able to continue or switch to an allowed alternative.

What data supports the effectiveness of the drug Atogepant for migraine prevention?

Atogepant has been approved in the USA for preventing migraines in adults, and studies have shown it to be effective and safe for long-term use in reducing the frequency of migraine attacks. ^{1 2 3 4 5}

Is Atogepant safe for humans?

Atogepant, also known as Qulipta, has been studied for its safety in preventing migraines. Clinical trials have assessed its long-term safety and tolerability, indicating it is generally safe for use in adults. ^{1 2 4 5 6}

How is the drug Atogepant different from other migraine treatments?

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 involved in migraine attacks. Unlike some other migraine treatments that are injected, Atogepant is taken as a pill, making it more convenient for many patients. ^{1 4 5 6 7}

What is the purpose of this trial?

This trial is testing a medication called Atogepant to see if it can safely and effectively prevent migraines in people who have them often. The medication works by blocking signals in the brain that cause migraines. Atogepant is a newly approved oral medication for the prevention of episodic migraine.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for people who have chronic or episodic migraines and were part of earlier studies without major issues or serious side effects. They shouldn't need any off-limits treatments, have significant heart problems, uncontrolled high blood pressure, a risk of self-harm, or other serious health conditions.

Inclusion Criteria

I completed previous study visits without major issues or unsafe side effects.

- Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not experience an Adverse Event that may indicate an unacceptable safety risk.

Exclusion Criteria

Your first ECG shows important irregularities.

Participants with a significant risk of self-harm, or of harm to others; participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded.

I have high blood pressure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Atogepant 60 mg daily for the prevention of migraine

156 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Atogepant

Trial Overview The study tests the long-term safety and tolerability of Atogepant 60 mg taken daily to prevent migraines. It's an extension study for participants from previous trials on this medication.

Participant Groups

Group I: Atogepant 60 mg Experimental Treatment 1 Intervention

Taken once daily

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

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

Findings from Research

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]

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]

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]

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, 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]

References

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

Atogepant: First Approval. [2022]

2. 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]

3. England 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. [2022]

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

Atogepant for the Preventive Treatment of Migraine. [2021]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

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

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

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