Active not recruitingPHASE3INTERVENTIONAL

Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine

This research study is investigating a drug called erenumab for children and teenagers between 6 and 17 years old who experience episodic migraines. Episodic migraines mean headaches that occur less than 15 days a month. The main aim is to see if erenumab can effectively reduce how often these young people get migraines compared to a dummy treatment (placebo). We also want to make sure the medicine is safe. Participants will receive different doses of erenumab or a placebo as a monthly injection. This is a "Phase 3" study, which means it's a larger study designed to confirm the medicine's benefits and safety before it might become more widely available.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Amgen

Enrolment target

457

Start

19 Jul 2019

Estimated completion

15 Nov 2026

Migraine

What is this study about?

Migraine headaches can be really tough for anyone, and especially for children and teenagers. This study is looking into a medicine called erenumab. It's hoped that erenumab can help prevent migraines from happening so often in young people aged 6 to 17. There are different types of migraines, and this study is focusing on 'episodic migraine', which means people who get migraines less than 15 days a month.

The main question this study wants to answer is simple: can erenumab reduce the number of migraine days a young person experiences each month? We also need to know if the medicine is safe to use. To do this, some participants will receive erenumab, while others will receive a 'placebo' – a treatment that looks just like erenumab but contains no active medicine. This helps researchers understand if the changes they see are truly due to the medicine or something else. Neither the participants, their families, nor the doctors will know who is getting which treatment during the main part of the study; this is called 'double-blind'.

By carefully comparing the results from the erenumab groups and the placebo group, the researchers hope to gather strong evidence about whether erenumab is a safe and effective option for preventing migraines in young people. Finding better ways to manage migraines could greatly improve the daily lives of children and teenagers who suffer from them.

Key takeaways

This study is testing a new migraine prevention medicine for children and teenagers.
It aims to see if erenumab can reduce how often young people get migraines.
Participants will receive either the active medicine or a 'dummy' treatment (placebo).
The medicine is given by monthly injection under the skin.
The study will check both how well the medicine works and if it's safe.
The study lasts for many months, including screening, treatment, and follow-up.

Who may be eligible?

To join this study, we are looking for children and teenagers between 6 and 17 years old. If you're under 18, a parent or legal guardian will need to give their permission for you to take part, and you'll also be asked if you're happy to join. You should have a history of migraines for at least 12 months, and these migraines should have been confirmed by a doctor.

Your migraines should be 'episodic', meaning you typically get fewer than 15 headache days a month. For at least 4 of those headache days each month, your headaches should be what you'd consider a migraine. We'll check this over a few months before you officially start the study medicine.

Migraines in children can sometimes look a bit different from adults. For example, headaches might last anywhere from 2 to 72 hours, and pain is often on both sides of the head rather than just one. These special considerations for younger people will be taken into account when deciding if the study is right for you.

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.

Are you between 6 and 17 years old?
Do your parents or legal guardians agree for you to take part?
Have you had migraines for at least one year?
Do you usually have fewer than 15 headache days per month?
Are at least 4 of those headache days migraine days each month?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve several steps over a period of time. First, there's a 'screening' phase which lasts about 7 weeks. This period includes checking if you're suitable for the study and recording your migraine headaches for 4 weeks to understand your usual pattern.

After screening, you'll enter the main 'double-blind treatment phase'. This part lasts either 12 or 24 weeks, depending on which group you are in. During this time, you will receive either erenumab or a placebo as an injection just under the skin, once a month. The dose of erenumab will depend on your body weight.

Following the main treatment phase, there's an optional 'extension phase' for up to 40 additional weeks, where all participants will receive erenumab. Finally, there's a 12-week 'safety follow-up phase' to monitor your health after your last dose of the study medicine. Throughout the study, you'll have regular visits to the clinic and will be asked to keep a diary of your migraine days.

Potential risks and benefits

Taking part in any medical study has both potential benefits and potential risks. A potential benefit of this study is that erenumab might help to reduce your migraines, improving your quality of life. You'll also receive careful medical attention throughout the study. However, like all medicines, erenumab could have side effects, which the study team will discuss with you. These could be mild, like pain at the injection site, or more serious. The placebo group will not receive the active drug, so they won't experience benefits from erenumab, but also won't have its side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (119)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Paradigm Clinical Research Center Inc
Verified postcode
San Diego, United States
Childrens Hospital Colorado
Verified postcode
Aurora, United States
Colorado Springs Neurological Associates
Verified postcode
Colorado Springs, United States
New England Institute for Clinical Research
Verified postcode
Stamford, United States
Childrens National Health System
Verified postcode
Washington D.C., United States
Northwest Florida Clinical Research Group Limited Liability Company
Verified postcode
Gulf Breeze, United States
Nicklaus Childrens Hospital
Verified postcode
Miami, United States
Pediatric Epilepsy and Neurology Specialists
Verified postcode
Tampa, United States
TrueBlue Clinical Research
Verified postcode
Tampa, United States
Premiere Research Institute
Verified postcode
West Palm Beach, United States
Rare Disease Research Center Pediatrics
Verified postcode
Atlanta, United States
CenExel iResearch, LLC
Verified postcode
Savannah, United States

Common questions

What is erenumab?

Erenumab is a medicine that blocks a specific protein in the body believed to play a key role in causing migraines. It's given as an injection.

What does 'episodic migraine' mean?

Episodic migraine means you get migraine headaches less than 15 days in a month. This study is for people who have this type of migraine.

What is a 'placebo'?

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

How will the medicine be given?

The study medicine (erenumab or placebo) will be given as an injection just under the skin once a month. The dose might be different depending on your weight.

How long will the study last?

The study involves a screening period, a main treatment phase of 12 or 24 weeks, an optional extension phase of 40 weeks, and a final safety follow-up of 12 weeks.