A Study of Erenumab Compared to Placebo for Children and Teenagers With Chronic Migraine to Test How Well It Works and How Safe It Is

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What is this study about?

This clinical trial is studying chronic migraine in children aged 6 to less than 12 years and adolescents aged 12 to less than 18 years. Chronic migraine is a condition where a person experiences headaches on 15 or more days per month, with at least 8 of those days being migraine headaches. Migraines are severe headaches that can cause throbbing pain, often accompanied by sensitivity to light and sound, and sometimes nausea. The treatment being tested is erenumab, which is also known by its code name AMG 334. This medication is given as an injection under the skin. Some participants will receive erenumab while others will receive a placebo.

The purpose of the study is to evaluate how well erenumab works compared with placebo in reducing the number of monthly migraine days in children and adolescents with chronic migraine. The study will also look at the safety of erenumab in this age group. The main focus is to see if there is a change in the number of migraine days per month from the start of the study to weeks 9 through 12 of the treatment period.

The study involves a treatment period where participants will be randomly assigned to receive either erenumab or placebo. During this time, participants will need to keep a daily electronic diary to record their headaches and migraine symptoms. The study will measure various aspects including the change in monthly migraine days, the change in monthly headache days, and whether participants achieve at least a 50 percent reduction in their monthly migraine days. The study will also assess how migraines affect daily activities and school performance in these young participants.

1 Baseline phase and electronic diary completion

Before the treatment begins, you will enter a baseline phase that lasts at least 28 days.

During this period, you will need to complete an electronic diary every day to record information about your headaches and migraines.

You must complete the diary entries for at least 23 out of the last 28 days to continue in the trial. This means achieving at least 80% compliance with diary completion.

The diary will help track how many days you experience headaches and how many of those are migraine days.

2 Beginning of double-blind treatment phase

After completing the baseline phase, you will begin the double-blind treatment phase. This means neither you nor your doctor will know whether you are receiving the actual medication or a placebo.

You will be randomly assigned to receive either erenumab or a placebo.

Erenumab is a solution for injection that will be administered under the skin (subcutaneous injection).

The placebo looks identical to the actual medication but contains no active substance.

3 Treatment administration during weeks 1 through 12

You will receive injections of either erenumab or placebo during the treatment phase.

The injections will be given under the skin at regular intervals as determined by the study protocol.

You will continue to record your headaches and migraines in the electronic diary throughout this entire period.

4 Primary evaluation period at weeks 9 through 12

The main evaluation of how well the treatment works will focus on weeks 9 through 12, which corresponds to month 3 of the treatment phase.

During this time, the number of days you experience migraines each month will be compared to the baseline period before treatment started.

The goal is to see if there is a reduction in the number of monthly migraine days.

You will continue completing the electronic diary daily to track your symptoms.

5 Additional assessments during the treatment phase

Throughout the first 12 weeks of treatment, additional measurements will be taken.

These include tracking the number of headache days per month, not just migraine days.

The severity of your migraine attacks will be recorded to see if they become less intense.

You will complete a questionnaire called the modified PedMIDAS, which measures how much migraines affect your daily activities, school performance, and ability to participate in normal activities.

The study will also assess whether you achieve at least a 50% reduction in monthly migraine days compared to the baseline period.

Who Can Join the Study?

The participant must be a child between 6 and 12 years old or a teenager between 12 and 18 years old at the time of signing the agreement to join the study.
The parent or legal representative, which means the adult who has the legal right to make decisions for the child, must provide written permission before any study activities begin.
The participant must have had a history of migraine, which is a type of severe headache that may come with or without aura (warning signs like seeing flashing lights or feeling tingling), for at least 12 months before joining the study. This must be confirmed by medical records or reports from the participant, parent, or legal representative.
The participant must have experienced at least 15 headache days per month, and at least 8 of those days must have been identified as migraine days, in each of the 3 months before screening for the study.
During the last 28 days of the initial observation period, the participant must have had at least 8 migraine days as recorded in the electronic diary, which is a digital tool used to track daily symptoms.
During the last 28 days of the initial observation period, the participant must have had at least 15 headache days as recorded in the electronic diary.
The participant must have completed the electronic diary entries on at least 80% of the days during the last 28 days of the initial observation period, which means filling out the diary on at least 23 out of 28 days.

Who Cannot Join the Study?

Pregnant women or women who are breastfeeding cannot take part in this study because the effects of the study medicine on unborn babies or nursing infants are not fully known.
You cannot participate if you have a history of cluster headaches, which are severe headaches that occur in groups or cycles, or hemiplegic migraine, a rare type of migraine that causes temporary weakness on one side of the body.
You are not eligible if you have experienced medication overuse headaches, which means using pain relief medicines too frequently, causing more headaches.
You cannot join if you have used onabotulinumtoxinA (also known as Botox, a medicine injected to prevent migraines) within 4 months before starting the study.
You are excluded if you have previously used medicines called CGRP inhibitors, which are drugs specifically designed to prevent migraines by blocking a protein in the body.
You cannot participate if you have used certain preventive migraine medications within specific time periods before the study begins, depending on the type of medicine.
You are not eligible if you have a serious medical condition affecting your heart, liver, kidneys, or other major organs that could make it unsafe for you to participate.
You cannot join if you have an active psychiatric disorder, which means a mental health condition that is not well controlled, or a history of drug or alcohol abuse within the past year.
You are excluded if you have any condition or illness that the study doctor believes would make it unsafe for you to participate or could affect the study results.
You cannot participate if you are allergic to the study medicine or any of its ingredients.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Medicine Greifswald	Greifswald	Germany

Other Sites

Site Name	City	Country
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
OHA-Med Sp. z o.o.	Warsaw	Poland
Schmerzklinik Kiel Gmbh & Co. KG Klinik fuer neurologisch-verhaltensmedizinische Schmerztherapie	Kiel	Germany
University Of Debrecen	Debrecen	Hungary
Semmelweis University	Budapest	Hungary
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Vrije Universiteit Brussel	Jette	Belgium
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Céphalées et Migraines Neurologie Générale EMG Electromyographie EEG Electroencéphalographie	Saint-Nicolas	Belgium
High Tech Medical Kft.	Budapest	Hungary
Centrum Leczenia MIGRE	Wroclaw	Poland
Uukbwnildrbyclqurkqff Ejmep Adh	Essen	Germany
Enlazeq	Mechelen	Belgium
Nztf Sorhp Sjg z osbl	Warsaw	Poland
Cxblplk Mbrpvhst Hzwf Cpgaqj	Lublin	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	02.01.2020
Germany	Not recruiting	02.01.2020
Hungary	Not recruiting	02.01.2020
Italy	Not recruiting	02.01.2020
Poland	Not recruiting	02.01.2020

Trial locations

Investigated drugs:

Erenumab

Erenumab is a medication used to prevent migraines. It works by blocking a protein in the body that is involved in causing migraine headaches. This medicine is given as an injection under the skin, usually once a month. In this study, erenumab is being tested to see if it can reduce the number of migraine days in children and teenagers who suffer from chronic migraines.

Placebo is an inactive substance that looks like the real medication but contains no active medicine. It is used in this study to compare against erenumab to help determine if erenumab is truly effective at reducing migraine days.

Chronic Migraine – Chronic migraine is a neurological condition characterized by frequent headache episodes that occur on 15 or more days per month for at least three months. At least 8 of these monthly headache days must have features typical of migraine headaches. The headaches are often accompanied by symptoms such as nausea, sensitivity to light, and sensitivity to sound. This condition significantly impacts daily activities and quality of life due to the high frequency of attacks. Chronic migraine can develop from less frequent migraine patterns over time. The condition affects both adults and adolescents, causing recurring episodes of moderate to severe head pain.

Trial ID:

2023-504928-26-00

Protocol code:

20160354

NCT ID:

NCT03832998

Trial Phase:

Therapeutic confirmatory (Phase III)

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A Study of Erenumab Compared to Placebo for Children and Teenagers With Chronic Migraine to Test How Well It Works and How Safe It Is

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?