Active not recruitingPHASE3INTERVENTIONAL

Study of Oral Atogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine

This study is looking into a new medicine called atogepant to help prevent menstrual migraines. These are severe headaches that happen around the time of a woman's period. The study aims to find out how effective atogepant is at stopping these migraines, whether it's safe to use, and if people can comfortably take it. Some participants will receive atogepant, while others will get a placebo (a pill with no medicine). We need about 430 women with menstrual migraines to take part across different medical centers worldwide. Their health will be regularly checked throughout the study.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AbbVie

Enrolment target

468

Start

10 Feb 2025

Estimated completion

01 Jul 2027

Menstrual Migraine (MM)

What is this study about?

Migraines are intense headaches, often throbbing, usually on one side of the head. They can come with other symptoms like feeling sick or being extra sensitive to light and sound. When these migraines consistently happen just before or during a woman's period, they're called menstrual migraines.

This study is focusing on a new medicine called atogepant, which is being developed specifically to help prevent these menstrual migraines. The main goals are to understand how well atogepant works to stop these migraines, if it's safe to use, and how easily people can manage any potential side effects. To do this, some participants will receive atogepant, and others will get a placebo – which looks exactly like the study medicine but doesn't contain any active drug. This helps researchers fairly compare the effects of the actual medicine.

Around 430 adult women with menstrual migraines will join this study at various medical centers worldwide. Participants will be randomly assigned to either receive atogepant or the placebo, meaning there's a 1 in 2 chance of getting the placebo. Everyone involved, including the study doctors, won't know who is getting which treatment until the study is over. This helps keep the results unbiased.

Key takeaways

The study tests a new medicine called atogepant for preventing menstrual migraines.
It aims to see how well atogepant works, its safety, and how well it is tolerated.
You might receive the new medicine or a dummy pill (placebo) initially.
Participation involves regular clinic visits, checks, and keeping a migraine diary.
Around 430 adult women are needed for this international study.

Who may be eligible?

To join this study, you would typically need to be an adult woman aged 18 or older who experiences menstrual migraines. Your periods should be regular, usually coming every 21 to 35 days.

You would need to have had migraines for at least a year, with the first migraine starting before you were 50. Importantly, your migraines should closely tied to your period, meaning you get them either just before or during your period in at least two out of every three cycles. You'll also need to keep a diary of your migraines during an initial screening period to confirm this.

You wouldn't be able to join if you have very frequent headaches (15 or more days per month), or if you have certain types of rare migraines like those affecting brain function or vision. Also, if you've needed emergency hospital treatment for migraines three or more times in the last six months, or have other serious health conditions like dementia or epilepsy, this study might not be suitable for you.

Quick self-check

Are you an adult woman (18 years or older)?
Do you have regular menstrual cycles (typically every 21-35 days)?
Do you get migraines usually just before or during your period?
Have you had migraines for at least a year, starting before you were 50?
Do you typically have fewer than 15 headache days per month?

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

What does participation involve?

If you join this study, you'll be assigned by chance to either take oral atogepant or a matching placebo (a dummy pill with no medicine). For the first three menstrual cycles, you and your doctors won't know which one you're taking. After this first part, everyone will receive atogepant during their menstrual cycles.

Throughout the study, you'll have regular visits at a hospital or clinic. These visits will involve medical checks, blood tests, and discussions about any side effects you might experience. You'll also complete questionnaires to help us understand how you're feeling and how the treatment is working. Keeping a diary of your menstrual cycles and migraines will also be an important part of your participation. The total duration of your participation will depend on the full study plan, but it involves several months of consistent follow-up.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical supervision. However, there are also potential risks; atogepant is still being investigated, and side effects are possible. Your involvement might also mean more hospital visits and tests than your usual care, which can be time-consuming. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (95)

Chinese PLA General Hospital /ID# 267141
Beijing, China
Nanfang Hospital - Southern Medical University /ID# 268510
Guangzhou, China
Hebei General Hospital /ID# 267663
Shijiazhuang, China
Renmin Hospital of Wuhan University /ID# 267671
Wuhan, China
The First Affiliated Hospital of Soochow University /ID# 267885
Suzhou, China
Shaanxi Provincial PeopleS Hospital /ID# 267827
Xi'an, China
First Affiliated Hospital of Shanxi Medical University /ID# 267680
Taiyuan, China
Tianjin Medical University General Hospital /ID# 268846
Tianjin, China
Tianjin People's Hospital /ID# 268511
Tianjin, China
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 267994
Hangzhou, China
Minksneuro /ID# 267651
Brno, Czechia
A-Shine s.r.o. /ID# 266048
Pilsen, Czechia

+83 more sites — see the official record for the full list.

Common questions

What is a placebo?

A placebo is a 'dummy pill' that looks exactly like the study medicine but contains no active drug. It helps researchers compare the real medicine's effects fairly.

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

For the first part of the study, neither you nor your doctors will know if you're taking atogepant or the placebo. This is to ensure the study results are fair and unbiased.

How long will I be in the study?

The study involves taking either atogepant or a placebo for three menstrual cycles, followed by a period where everyone receives atogepant during their menstrual cycle. The total length will be explained by the study team.

What kind of visits will I have?

You will have regular visits to a hospital or clinic for medical checks, blood tests, discussions about your health, and to fill out questionnaires.

Can I stop participating if I want to?

Yes, you are free to leave the study at any time, for any reason, without it affecting your future medical care.