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Active not recruitingOBSERVATIONAL

Observational Study of Oral Atogepant to Evaluate Real-World Effectiveness in Adult Participants With Migraine

This study is an important look at how a medication called atogepant helps adult migraine sufferers in their daily lives. Migraine is a condition that causes severe headaches, often with sickness and sensitivity to light and sound. Atogepant is already approved in the UK for preventing migraine attacks. If your doctor prescribes it, you might be invited to join this study, which will follow about 1,000 people worldwide for two years. You'll take atogepant as your doctor advises, and your progress will be monitored during your regular hospital or clinic visits. The good news is that taking part won't add any extra appointments or burdens beyond your usual care, making it easy to contribute to understanding migraine treatment.

At a glance

Status
Active not recruiting
Sponsor
AbbVie
Enrolment target
1,314
Start
26 Nov 2024
Estimated completion
01 Feb 2029

What is this study about?

This study is designed to observe how an approved migraine prevention medicine, called atogepant, works for adults in a real-world setting. Migraine is a neurological condition that causes very bad headaches, often with feeling sick, being sick, and being very sensitive to light and sound. Atogepant has been approved as a treatment to help prevent these migraine attacks.

The main aim of this study is to see how effective atogepant is for people dealing with migraines every day. Researchers will follow around 1,000 adults from different places who have been prescribed atogepant by their doctors for migraine prevention. This helps us understand how the medicine works for a wide range of people in typical treatment conditions.

Participation in the study involves taking atogepant as your doctor has prescribed and attending your usual check-ups at the hospital or clinic over two years. There won't be any extra appointments or tests specifically for the study, which means it shouldn't add any burden to your routine care. It's a way to learn more about how this treatment works for people like you.

Key takeaways

  • This study observes how an approved migraine medicine, atogepant, works in daily life.
  • It involves adults who are already prescribed atogepant by their doctor.
  • Participation means attending your regular medical appointments for two years.
  • There are no extra study visits or burdens beyond your usual care.
  • The findings will help doctors better understand migraine treatment.
  • You can stop participating at any time.

Who may be eligible?

To be able to join this study, you need to be an adult (18 years or older) who has had migraines for at least a year. You must also have been prescribed atogepant by your doctor as part of your standard care. It's important that your doctor's decision to prescribe atogepant happened independently, before you were asked about joining the study.

If you're already taking another medicine to prevent migraines, that's okay, as long as you've been on a steady dose for at least three months and there are no plans to change it during the first 12 weeks of the study. You also need to be willing and able to follow the study's requirements, which mainly involve attending your regular appointments.

You cannot join this study if you've previously taken atogepant, either through a specific clinical trial or as routine treatment. Also, if you're pregnant, planning to become pregnant, or could become pregnant and aren't using contraception, you won't be able to participate. Finally, if your doctor believes there's any other reason you shouldn't join, or if you're already in another research study involving migraine treatments, you won't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with migraine for at least a year?
  3. Has your doctor already prescribed you atogepant?
  4. Are you able and willing to attend your regular clinic appointments?
  5. Are you not pregnant, planning pregnancy, or could become pregnant without using contraception?
  6. Have you not previously taken atogepant before being asked to join this study?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll continue to take your atogepant tablets exactly as prescribed by your doctor. The study will follow you for two years. During this time, you won't have any extra appointments specifically for the study. Instead, the study team will gather information during your regular check-ups at your hospital or clinic. This means you won't have any additional trips or tests beyond your usual medical care for migraine. Your progress will be monitored during these routine visits as part of the study.

Potential risks and benefits

The main benefit of taking part is that you'll be contributing important information to medical science, which will help doctors better understand how atogepant works for people with migraine in real-world situations. Since you're already receiving atogepant as part of your normal care, there are no expected additional risks from participating in this study beyond the usual risks associated with taking the medication itself. You are completely free to withdraw from the study at any time without affecting your medical care.

Locations (112)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Neurology and Neurodiagnostics of Alabama /ID# 267614
    Verified postcode
    Hoover, United States
  • Rehabilitation & Neurological Services /ID# 267612
    Verified postcode
    Huntsville, United States
  • Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 267610
    Verified postcode
    Phoenix, United States
  • Kenneth Martinez MD, A Medical Corp /ID# 267834
    Verified postcode
    Aliso Viejo, United States
  • BNL Health - Los Angeles Headache Center /ID# 267570
    Verified postcode
    Los Angeles, United States
  • Alcanza Clinical Research, LLC /ID# 267838
    Verified postcode
    Lake Mary, United States
  • Norton Cancer Institute - St. Matthews /ID# 267605
    Verified postcode
    Louisville, United States
  • Dent Neurologic Institute - Amherst /ID# 267606
    Verified postcode
    Amherst, United States
  • Northwell Health - Great Neck /ID# 280705
    Verified postcode
    Great Neck, United States
  • Northwell Health /ID# 267596
    Verified postcode
    New York, United States
  • Thomas Jefferson University Hospital /ID# 267572
    Verified postcode
    Philadelphia, United States
  • Inova Health Care System /ID# 267615
    Verified postcode
    Falls Church, United States

Common questions

What is atogepant?

Atogepant is a medicine approved to help prevent migraine attacks in adults.

Will I get extra doctor's appointments because of this study?

No, you'll only attend your usual, routine appointments at your hospital or clinic.

How long will I be in the study?

The study will follow your progress for two years.

Do I have to do anything special for the study?

You just need to take your atogepant as prescribed and go to your regular doctor visits.

Can I stop being in the study if I change my mind?

Yes, you can leave the study at any time without it affecting your medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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