Atogepant vs Topiramate for Migraine

(ATO-TOPIRAMATE Trial)

Recruiting at 126 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Cardiovascular, Cerebrovascular, Endocrine, 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

Compensation: Varies

Number of Visits: Unknown

545 Participants Needed

Trial Summary

What is the purpose of this trial?

A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The main goal of the study is to evaluate the tolerability (how patients handle the study treatment) and safety of atogepant compared to topiramate in participants with migraine. Atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. Topiramate is an approved medication for migraine prevention. This study is conducted in 2 periods. In Period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. In Period 2, eligible participants will receive atogepant. Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world. Participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in Period 1. Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth. After 24 weeks, all eligible participants will receive atogepant for 52 weeks in Period 2. Participants are monitored for safety for 4 weeks after their last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, since the study involves taking either atogepant or topiramate, it's possible that changes to your current migraine treatment may be required. Please consult with the trial coordinators for specific guidance.

Is Atogepant and Topiramate safe for humans?

Atogepant and Topiramate are generally considered safe for humans. Atogepant is approved for preventing migraines, and Topiramate is used for both epilepsy and migraine prevention. Common side effects of Topiramate include tingling sensations, fatigue, and taste changes, but these are usually mild and temporary. ^{1 2 3 4 5}

How does the drug combination of Atogepant and Topiramate differ from other migraine treatments?

Atogepant is a novel oral drug that works by blocking a specific protein involved in migraine attacks, while Topiramate is an antiepileptic drug repurposed for migraine prevention. Their combination offers distinct mechanisms of action, potentially enhancing migraine prevention compared to using either drug alone. ^{1 2 6 7 8}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

Adults with a history of migraines for at least 12 months, experiencing 4 or more migraine days per month and needing preventive treatment. Participants should not have used Atogepant or Topiramate before and must be free from significant health issues in major body systems like the heart, brain, blood, hormones, lungs, kidneys, liver, stomach or nerves.

Inclusion Criteria

I have had migraines for at least 12 months.

I experience 4 or more migraine days per month and need preventive treatment.

Exclusion Criteria

I have taken topiramate or atogepant before.

I have a serious heart, blood, hormone, lung, kidney, liver, stomach, brain or nerve condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive either atogepant or topiramate for 24 weeks

24 weeks

Regular visits at a hospital or clinic

Open-label Extension

Eligible participants receive atogepant for 52 weeks

52 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
• Topiramate

Trial Overview The trial is testing the tolerability and safety of Atogepant compared to Topiramate for preventing migraines. Initially participants are randomly assigned to receive either Atogepant with placebo for Topiramate or vice versa for 24 weeks; afterwards all eligible participants will take Atogepant for an additional 52 weeks.

Participant Groups

Group I: Atogepant Experimental Treatment 2 Interventions

Participants will receive atogepant in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.

Group II: Topiramate Active Control 3 Interventions

Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.

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

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]

References

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

Pharmacokinetics and Safety of Coadministered Atogepant and Topiramate in Healthy Participants: A Phase 1, Open-Label, Drug-Drug Interaction Study. [2023]

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

Atogepant: First Approval. [2022]

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

Are migraineurs at increased risk of adverse drug responses? A meta-analytic comparison of topiramate-related adverse drug reactions in epilepsy and migraine. [2018]

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

Topiramate in the prevention and treatment of migraine: efficacy, safety and patient preference. [2021]

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

Practical use of topiramate for migraine prevention. [2018]

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

Zonisamide versus topiramate in migraine prophylaxis: a double-blind randomized clinical trial. [2018]

7. England pubmed.ncbi.nlm.nih.gov

European Headache Federation (EHF) critical reappraisal and meta-analysis of oral drugs in migraine prevention - part 3: topiramate. [2023]

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

Zonisamide for migraine prophylaxis in patients refractory to topiramate. [2018]