Atogepant + Botox for Chronic Migraine

(ATO-BOTOX Trial)

Recruiting at 36 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must be taking: Botox

Must not be taking: Opioids, mAbs, oral gepants

Disqualifiers: Acupuncture, TENS, 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: 24 weeks

75 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new daily pill called atogepant, used along with regular BOTOX treatments, to help prevent migraines. It targets adults who suffer from frequent and severe headaches. The pill works by blocking certain brain signals that trigger migraines. The study will monitor safety, side effects, and effectiveness over several months. Atogepant is a newly approved medication for the prevention of migraine.

Will I have to stop taking my current medications?

The trial requires that you continue using Botox for chronic migraine, but you cannot use other migraine prevention treatments besides Botox or topiramate (up to 100mg daily). If you are using oral gepants or certain other treatments, you may need to stop before joining the trial.

What data supports the effectiveness of the drug Atogepant for treating chronic migraine?

Atogepant has been shown to be effective in preventing migraines, as it is approved in the USA for the preventive treatment of episodic migraine in adults. Studies have demonstrated its safety, tolerability, and efficacy in reducing the frequency of migraines. ^{1 2 3 4 5}

Is Atogepant (Qulipta) safe for humans?

Atogepant (Qulipta) has been studied for its safety in preventing migraines, and long-term studies have shown it to be generally safe and well-tolerated in adults. ^{2 4 5 6 7}

How does the drug Atogepant + Botox differ from other treatments for chronic migraine?

Atogepant is unique because it is an oral medication that blocks the CGRP receptor, which is involved in migraine development, while Botox is an injectable treatment that prevents migraines by relaxing muscles and blocking pain signals. This combination offers a novel approach by using both an oral and injectable method to prevent chronic migraines. ^{2 3 4 5 8}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

Adults with chronic migraine who've been treated with BOTOX for at least two cycles in the past 8 months and have had 8-23 migraine days during a screening period. Participants must not have used certain migraine medications recently, including CGRP pathway blockers or oral gepants, and should not be on other preventive treatments besides BOTOX.

Inclusion Criteria

I have been receiving BOTOX for chronic migraines, with at least 2 treatments in the last 8 months.

I have had chronic migraines for at least a year.

Must have 8 to 23 (inclusive) migraine days in the electronic diary [eDiary] screening/baseline period (eDiary data must have been collected for at least 20 days)

Exclusion Criteria

I've used opioids for headaches more than 4 days a month recently.

I haven't had treatments like acupuncture or TENS on my head/neck muscles in the last 4 weeks.

I have used CGRP-blocking medication in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atogepant oral tablet once a day in addition to their standard of care Botox during the 24-week treatment period

24 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

Trial Overview The trial is testing the safety and effectiveness of an investigational drug called Atogepant when added to standard BOTOX treatment for preventing migraines. Around 125 participants will take Atogepant daily for 24 weeks while continuing their regular BOTOX injections.

Participant Groups

Group I: Atogepant Experimental Treatment 1 Intervention

Participants will receive atogepant once a day (QD) during the 24-week treatment period.

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

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 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]

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]

Olcegepant and telcagepant, both calcitonin-gene-related peptide receptor antagonists, significantly improve pain relief and pain-free rates in migraine patients compared to placebo, with olcegepant showing a notable effect at 2 hours post-treatment.

While olcegepant has a similar incidence of adverse reactions as placebo, telcagepant at higher doses (300 mg) does show a higher rate of adverse effects, indicating a need for monitoring liver transaminases with long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effects and safety of olcegepant and telcagepant for migraine: A meta-analysis. Yao, G., Yu, T., Han, X., et al.[2021]

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]

References

1. 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]

2. 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]

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

Atogepant for the Preventive Treatment of Migraine. [2021]

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

Atogepant: First Approval. [2022]

5. 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]

6. India pubmed.ncbi.nlm.nih.gov

Therapeutic effects and safety of olcegepant and telcagepant for migraine: A meta-analysis. [2021]

7. 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]

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

A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single-Dose, Phase 1 Crossover Trial. [2022]