Atogepant for Migraine

Recruiting at 9 trial locations

Overseen By ABBVIE CALL CENTER

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: AbbVie

Disqualifiers: Hypertension, Cardiovascular, Neurologic, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Migraine is a disease that most often causes 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. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age. Atogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world. Participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks. Participants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, medical assessments, blood tests, checking for side effects, and completing questionnaires.

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.

What data supports the effectiveness of the drug Atogepant for treating migraines?

Research shows that Atogepant, taken as a daily pill, is effective in preventing migraines. Studies have demonstrated its safety and ability to reduce the frequency of migraine episodes in adults. ^{1 2 3 4 5}

Is atogepant safe for humans?

Atogepant has been studied for its safety in preventing migraines, and research shows it is generally safe and well-tolerated in adults over long-term use. ^{1 3 4 5 6}

How is the drug atogepant different from other migraine treatments?

Atogepant is unique because it is an oral medication that works by blocking the calcitonin gene-related peptide (CGRP) receptor, which plays a key role in causing migraines. This makes it different from other treatments that may not target this specific pathway. ^{1 4 5 6 7}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Atogepant (Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist)

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.

Participant Groups

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

Findings from Research

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 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 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 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 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]

References

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

Atogepant for the Preventive Treatment of Migraine. [2021]

2. United States 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. [2023]

3. 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]

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

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

6. 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]

7. Spain pubmed.ncbi.nlm.nih.gov

Atogepant for migraine. [2022]