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

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What is this study about?

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.

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.

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.

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
University Medicine Greifswald	Greifswald	Germany
Hospital Universitario De Navarra	Pamplona	Spain
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
Athleticomed Sp. z o.o.	Bydgoszcz	Poland
Clinical Research Center Sp. z o.o. Medic-R sp.k.	Poznan	Poland
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
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Da Luz S.A.	Lisbon	Portugal
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
Uzbzxsgobceokcgxxzkod Eealk Acd	Essen	Germany
Eekmvea	Mechelen	Belgium
Nfwi Ssjgi Sld z owfw	Warsaw	Poland
Crvzelv Mbqjrqwg Hwvd Ciaoqd	Lublin	Poland
Uqfnmksapjyluq Crqdxpk Kxwzmmtrd	Gdansk	Poland
Hwxjehda Dj Lh Skyye Chft I Sswo Ptf	Barcelona	Spain
Henqvczq Vkqx dnlpdvxb	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	16.12.2019
Germany	Not recruiting	16.12.2019
Hungary	Not recruiting	16.12.2019
Italy	Not recruiting	16.12.2019
Poland	Not recruiting	16.12.2019
Portugal	Not recruiting	16.12.2019
Spain	Not recruiting	16.12.2019

Trial locations

Investigated drugs:

Erenumab

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.

Investigated diseases:

Migraine

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.

Trial ID:

2023-504930-23-00

Protocol code:

20150125

NCT ID:

NCT03836040

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?