Not recruiting

Study of Erenumab Compared to Placebo for Children and Adolescents with Episodic Migraine to Reduce Monthly Migraine Days

Fast replyInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines episodic migraine in children aged 6 to under 12 years and in adolescents aged 12 to under 18 years. Episodic migraine refers to migraine headaches that occur on fewer than 15 days per month, with at least 4 of those days being migraine days. The treatment being tested is erenumab, which is also known by its code name AMG 334. This medication is given as a solution for injection that is administered under the skin using a pre-filled syringe. Some participants will receive erenumab while others will receive placebo. The purpose of the study is to evaluate how well erenumab works compared with placebo in reducing the number of monthly migraine days.

The study has a double-blind design, which means that neither the participants nor the doctors will know who is receiving the actual medication and who is receiving placebo. Before starting treatment, participants will complete a baseline period where they record their headaches and migraines in an electronic diary. During this time, they must have at least 4 but fewer than 15 migraine days and fewer than 15 total headache days in a 28-day period. The main treatment phase lasts for 12 weeks, during which participants will receive injections of either erenumab or placebo. The maximum treatment period can extend up to 83 weeks, with the highest dose being 140 milligrams per injection.

Throughout the study, participants will continue to record their headaches and migraines in the electronic diary to track changes in the number of migraine days per month. The study will also measure changes in the number of total headache days, the severity of migraine attacks, and how much migraine affects daily activities and school performance. The main focus is on comparing the change in monthly migraine days between those receiving erenumab and those receiving placebo during weeks 9 through 12 of the treatment phase. Participants must have had a history of migraine with or without aura for at least 12 months before joining the study, and the diagnosis must follow established international headache classification criteria.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline phase with electronic diary
During the baseline phase, you will use an electronic diary to record your headaches and migraines daily for at least 28 days.
You must complete the diary entries on at least 23 out of the last 28 days to continue in the study.
The diary will help track how many days you experience headaches and migraines before treatment begins.
Step 2
Double-blind treatment phase
After the baseline phase, you will enter the double-blind treatment phase, which lasts for 12 weeks (3 months).
During this phase, you will receive either erenumab or placebo (an inactive substance that looks like the real medication). Neither you nor your doctor will know which one you are receiving.
Erenumab is a medication designed to prevent migraines. It will be given as an injection under the skin (subcutaneous injection).
You will continue to record your headaches and migraines in the electronic diary throughout this phase.
The study will measure how many days per month you experience migraines, comparing the period from week 9 through week 12 to your baseline recordings.
Step 3
Assessment of treatment effects
Throughout the treatment phase, several aspects of your condition will be monitored.
The number of monthly migraine days (days when you have a migraine) will be tracked and compared to your baseline.
The number of monthly headache days (any day with a headache) will also be recorded.
The severity of your migraine attacks will be assessed to see if there is any change from baseline.
Your migraine-related disability will be measured using a modified questionnaire called PedMIDAS, which evaluates how migraines affect your daily activities and school performance.

Who can join the trial?

8 criteria

The child must be between 6 and less than 12 years old, or the adolescent must be between 12 and less than 18 years old at the time of agreeing to join the study.
The parent or legal representative (a person who has legal authority to make decisions for the child) must provide written permission before any study activities begin.
The child or adolescent must have a history of migraine (a type of severe headache that may include throbbing pain, nausea, and sensitivity to light and sound) with or without aura (warning signs before a migraine such as seeing flashing lights or feeling tingling) for at least 12 months before joining the study. This diagnosis must follow specific medical guidelines and be confirmed by medical records or reports from the child or parent.
For children under 18 years old, migraine attacks may last between 2 and 72 hours, and the pain may be felt on both sides of the head rather than just one side.
The child or adolescent must have experienced fewer than 15 headache days per month, with at least 4 of those days being migraine days, during each of the 3 months before starting the study.
During the last 28 days of the baseline phase (the initial observation period before treatment starts), the child or adolescent must have between 4 and less than 15 migraine days recorded in the electronic diary.
During the last 28 days of the baseline phase, the child or adolescent must have fewer than 15 total headache days recorded in the electronic diary.
The child or adolescent must complete the electronic diary (a digital tool to record daily headache information) at least 80% of the time during the last 28 days of the baseline period, meaning entries must be made on at least 23 out of 28 days.

Who cannot join the trial?

15 criteria

You have chronic migraine, which means you have headaches on 15 or more days per month
You have experienced cluster headaches, which are severe headaches that occur in groups or clusters over a period of time
You have any other type of headache disorder that is not episodic migraine
You are currently pregnant, planning to become pregnant during the study, or breastfeeding
You have used certain migraine prevention medications within a specific time period before joining the study
You have previously used medications that block a protein called CGRP, which is involved in migraine pain
You have a history of serious heart problems, stroke, or blood vessel disease in the brain
You have uncontrolled high blood pressure, meaning your blood pressure is too high even with medication
You have severe liver or kidney disease that affects how these organs work
You have a history of drug or alcohol abuse within the past year
You have a serious mental health condition that is not well controlled
You have an active infection or disease that affects your immune system
You have had cancer within the past 5 years, except for certain skin cancers that have been successfully treated
You are allergic to the study medication or any of its ingredients
You are participating in another clinical trial or have recently participated in one

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centro Hospitalar E Universitario De Coimbra E.P.E.
Coimbra, Portugal
Verified
Emmaues
Mechelen, Belgium
Responsive
Semmelweis University
Budapest, Hungary

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Erenumab
is a medication used to prevent migraine headaches. It works by blocking a substance in the body that is involved in causing migraines. In this study, erenumab is being tested to see if it can reduce the number of days children and teenagers experience migraine headaches each month.
Placebo
is an inactive substance that looks like the real medication but contains no active medicine. It is used in the study to compare against erenumab to help determine if the actual medication is effective in reducing migraine days.

Erenumab

What is already known about the treatment

Erenumab – Erenumab is an injectable medication given under the skin that works by blocking a specific protein called CGRP receptor, which plays a key role in causing migraine headaches. This medicine is approved and widely used for preventing migraine attacks in adults, and is currently being studied in children and adolescents aged 6 to 17 years with episodic migraine. It belongs to a class of drugs called monoclonal antibodies, which are specialized proteins designed to target specific molecules in the body to prevent migraine episodes from occurring.

Investigated diseases

Episodic Migraine – Episodic migraine is a neurological condition characterized by recurring headache attacks that occur fewer than 15 days per month. The headaches are typically moderate to severe in intensity and often affect one side of the head. During an attack, individuals may experience throbbing or pulsating pain that can last from several hours to up to three days. The condition commonly includes additional symptoms such as sensitivity to light and sound, nausea, and sometimes vomiting. Migraine attacks can significantly interfere with daily activities, school attendance, and overall quality of life. The frequency and severity of attacks can vary from person to person and may change over time.