RecruitingPHASE3INTERVENTIONAL

A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years

This study is looking into a new tablet called atogepant for young people aged 12 to 17 who experience chronic migraines. Migraines are severe headaches that can come with other symptoms like sickness or sensitivity to light. Atogepant is already approved for adults, and this study will check if it's safe and effective for teenagers. Participants will take either atogepant or a placebo (a tablet with no medicine) daily for 12 weeks, with a follow-up period. Neither the participants nor the doctors will know who is getting which treatment. We aim to involve about 420 young people to understand if atogepant can reduce migraines.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AbbVie

Enrolment target

420

Start

13 Feb 2025

Estimated completion

01 Mar 2031

Chronic Migraine

What is this study about?

Imagine constantly dealing with really bad headaches that can make you feel sick, sensitive to light and sounds, and just generally unwell – that's what chronic migraine can be like for some young people. This study is specially designed for teenagers aged 12 to 17 who experience these frequent and severe headaches.

The main goal of this research is to see if a medicine called atogepant can help prevent these migraines. Atogepant is already used by adults in some parts of the world to stop migraines from happening. Now, doctors want to find out if it's a safe and effective option for younger people too. Another key part of the study is to understand any side effects that might occur with this medicine.

To make sure the results are fair, some participants will receive atogepant, and others will get a 'placebo' – this looks exactly like the real medicine but contains no active ingredients. This helps researchers compare the effects accurately. Nobody in the study, not even the doctors, will know who is taking which tablet until the study is over. About 420 young people from different places around the world will take part in this important research.

Key takeaways

This study is for young people aged 12-17 with chronic migraines.
It tests a new migraine prevention tablet called atogepant.
Some participants will get the actual medicine, others a dummy pill (placebo).
No one will know who gets which treatment until the study ends.
Participation involves daily tablets for 12 weeks, plus regular visits and a daily diary.
The study aims to see if atogepant is safe and effective for this age group.

Who may be eligible?

To join this study, you would need to be aged between 12 and 17 years old. You should have been experiencing chronic migraines for at least six months, which means you have headaches on 15 or more days a month, with at least 8 of those being migraines.

Before you start, you'd need to have filled in a special diary for at least 20 out of 28 days to track your headaches. This helps the study team understand your migraine pattern.

However, you wouldn't be able to join if you have certain other serious health conditions. For example, if you have very high blood pressure that needs close monitoring, or if you have significant problems with your blood, hormones, lungs, kidneys, liver, stomach, heart, or brain, this study might not be suitable for you.

Quick self-check

I am between 12 and 17 years old.
I have had chronic migraines for at least 6 months.
I have headaches on 15 or more days a month, with 8 or more of those being migraines.
I am able to complete a daily diary to track my headaches.
I do not have other serious health conditions affecting my blood, heart, lungs, kidneys, liver, or brain.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would receive either the atogepant tablet or a placebo tablet once every day for 12 weeks. Following this treatment period, you would be monitored for another 4 weeks, bringing the total study duration for you to about 16 weeks.

During this time, you would have regular visits to a hospital or clinic. At these visits, doctors and nurses would check on your health and see how you're responding to the treatment. You would also be asked to keep a daily diary to record your headaches and any changes you notice. To keep an eye on your health, you might have medical check-ups, blood tests, and be asked to fill out questionnaires about how you're feeling. They will also carefully look for any side effects.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit of reducing your migraine frequency and severity. However, there are also potential risks; you might experience side effects from the medication, or you might receive the placebo and not get the active treatment. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (63)

Rehabilitation and Neurological Services /ID# 270782
Huntsville, United States· Recruiting
Preferred Research Partners - Fayetteville /ID# 270419
Fayetteville, United States· Completed
Preferred Research Partner, Inc /ID# 270389
Little Rock, United States· Recruiting
Advanced Research Center /ID# 270257
Anaheim, United States· Recruiting
Neuro Pain Research Center /ID# 271048
Fresno, United States· Recruiting
Accellacare - Long Beach /ID# 270398
Long Beach, United States· Recruiting
Excell Research /ID# 270258
Oceanside, United States· Recruiting
Lumos Clinical Research Center /ID# 270582
San Jose, United States· Recruiting
Sunwise Clinical Research /ID# 270431
Walnut Creek, United States· Recruiting
Northwest Florida Clinical Research Group, LLC /ID# 270833
Gulf Breeze, United States· Recruiting
Auzmer Research /ID# 271158
Lakeland, United States· Completed
My Preferred Research /ID# 270312
Miami, United States· Recruiting

+51 more sites — see the official record for the full list.

Common questions

What is chronic migraine?

Chronic migraine means you have headaches on 15 or more days a month, and at least 8 of those days are severe migraines, for several months.

What is a placebo?

A placebo is a tablet that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the effects of the real medicine.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor the study doctors will know whether you are receiving atogepant or the placebo until the study is finished. This is called 'double-blinded'.

How long will the study last for me?

If you participate, you will take the study tablet for 12 weeks and then be followed for another 4 weeks, making your total involvement about 16 weeks.

Where would I go for study visits?

You would attend regular appointments at a hospital or clinic that is part of the study.

How to find out more

ABBVIE CALL CENTER

abbvieclinicaltrials@abbvie.com 844-663-3742 Official trial record

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