Study on Galcanezumab for Preventing Episodic Migraine in Children and Teens Aged 6 to 17

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What is this study about?

This clinical trial is focused on studying episodic migraine in children and teenagers aged 6 to 17 years. The treatment being tested is called Galcanezumab, which is a solution for injection. It is also known by its code name, LY2951742. The study aims to evaluate how effective and safe Galcanezumab is in preventing migraine headaches in young participants.

Participants in the study will receive either Galcanezumab or a placebo over a period of three months. The study is designed to compare the effects of Galcanezumab with the placebo to see if it can reduce the number of days participants experience migraine headaches each month. The study is conducted in a way that neither the participants nor the researchers know who is receiving the actual medication or the placebo, which is known as a double-blind study.

The main goal is to determine if Galcanezumab is better than the placebo in decreasing the frequency of migraine headaches. This study is part of ongoing research to find effective treatments for managing migraines in young people, aiming to improve their quality of life by reducing the burden of migraine attacks.

1 joining the study

Upon joining the study, the participant is confirmed to have a diagnosis of migraine with or without aura, as defined by the International Headache Society guidelines.

The participant must have a history of migraine headaches for at least 6 months prior to the screening.

2 initial assessment

An initial assessment is conducted to establish a baseline for the number of monthly migraine headache days.

This baseline will be used to measure changes throughout the study.

3 treatment period

The treatment period lasts for 3 months and is double-blind, meaning neither the participant nor the researchers know who receives the actual medication or the placebo.

Participants receive either galcanezumab or a placebo. Both are administered as a solution for injection.

The primary goal is to evaluate the effectiveness and safety of galcanezumab in reducing the number of monthly migraine headache days.

4 follow-up assessments

Throughout the treatment period, regular follow-up assessments are conducted to monitor the participant’s response to the treatment.

These assessments help determine any changes in the frequency of migraine headache days.

5 end of study evaluation

At the end of the 3-month treatment period, a final evaluation is conducted.

The primary endpoint is the change from baseline in the number of monthly migraine headache days.

Who Can Join the Study?

The patient must be between 6 and 17 years old.
The patient can be either male or female.
The patient must have a diagnosis of migraine. A migraine is a type of headache that can cause severe pain, often accompanied by nausea and sensitivity to light and sound.
The patient may have migraines with or without aura. An aura is a visual or sensory disturbance that some people experience before a migraine, like seeing flashing lights or feeling tingling.
The patient must have had a history of migraine headaches for at least 6 months before the screening for the study.

Who Cannot Join the Study?

Participants who are not between the ages of 6 to 17 years old.
Participants who do not have episodic migraine. This means they do not experience migraine headaches that occur on some days but not every day.
Participants who have any other medical condition that might interfere with the study or make it unsafe for them to participate.
Participants who are currently taking other medications that could affect the study results.
Participants who have had a recent change in their migraine treatment plan.
Participants who are unable to follow the study procedures or attend the required visits.
Participants who have a history of not following medical advice or treatment plans.
Participants who are pregnant or breastfeeding.
Participants who have participated in another clinical trial recently.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Sanos A/S	Gandrup	Denmark
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Isala Klinieken Stichting	Zwolle	The Netherlands
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hkcvpp Hdurudrq	Herlev	Denmark
Heclrwkf Dc Lg Sdmey Ciem I Spcj Prp	Barcelona	Spain
Umcnsqediw Dgart Syymm Dt Rtmj Lw Stmggrxm	Rome	Italy
Hztiawnr Vmwy dmcmzgki	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	26.03.2021
Italy	Not recruiting	26.03.2021
Spain	Not recruiting	26.03.2021
The Netherlands	Not recruiting	26.03.2021

Trial locations

Investigated drugs:

Galcanezumab

Galcanezumab is a medication being studied for its ability to prevent migraines in children and teenagers aged 6 to 17. It is designed to reduce the number of days each month that a person experiences migraine headaches. The study aims to determine if galcanezumab is more effective than a placebo in achieving this goal over a three-month period.

Investigated diseases:

Migraine

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often accompanied by nausea, vomiting, and sensitivity to light and sound. These headaches typically occur on one side of the head and can last from a few hours to several days. Migraine attacks may be preceded by warning symptoms known as aura, which can include visual disturbances or tingling sensations. The frequency and severity of migraines can vary widely among individuals, with some experiencing chronic episodes. Factors such as stress, hormonal changes, certain foods, and environmental triggers can contribute to the onset of a migraine. Over time, migraines can significantly impact daily activities and quality of life.

Trial ID:

2023-505836-36-00

Protocol code:

I5Q-MC-CGAS

NCT ID:

NCT03432286

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Galcanezumab for Preventing Episodic Migraine in Children and Teens Aged 6 to 17

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?