Recruiting

Long-term safety study of eptinezumab given by intravenous infusion for children and adolescents aged 6-17 years with chronic or episodic migraine

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study focuses on children and adolescents who suffer from migraine, a condition that causes severe headaches often accompanied by sensitivity to light and sound, nausea, and other symptoms. The study will evaluate a medication called eptinezumab (also known as VYEPTI), which is given through intravenous administration (delivered directly into a vein).

The main purpose is to examine the long-term safety of eptinezumab in young patients aged 6 to 17 years who have either chronic migraine (frequent headaches occurring 15 or more days per month) or episodic migraine (less frequent headaches). The study will continue for 36 months, during which participants will receive the medication every 12 weeks.

During the study, doctors will monitor how the participants respond to the treatment by checking for any side effects and measuring the amount of medication in their blood. They will also assess how the treatment affects the participants' daily activities and their ability to function at school and in other settings using special questionnaires designed for young people with migraine.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment
You will receive VYEPTI, a medication containing eptinezumab, through an intravenous infusion (delivered directly into your vein).
This treatment is specifically designed for children and adolescents aged 6 to 17 who experience chronic or episodic migraine.
Step 2
Regular assessments - Week 12
Your doctor will evaluate how your body responds to the treatment.
You will complete a PedMIDAS questionnaire (a form that measures how migraines affect your daily activities).
Blood samples will be taken to measure the concentration of the medication in your system.
Step 3
Continued monitoring - Week 24
Another assessment of your response to the treatment will be conducted.
You will complete another PedMIDAS questionnaire.
Blood tests will check for the presence of antibodies (substances your body might produce in response to the medication).
Step 4
Final evaluation - Week 36
A final comprehensive assessment will be performed.
You will complete a final PedMIDAS questionnaire.
The medical team will document any side effects that occurred during the treatment period.
Final blood tests will be conducted to measure medication levels and antibodies.

Who can join the trial?

7 criteria

Must be between 6 and 17 years old
Must have completed Week 12 visit of a previous migraine study (either for chronic migraine - recurring headaches occurring 15 or more days per month, or episodic migraine - headaches occurring less than 15 days per month)
Can be either male or female
Must have been diagnosed with either chronic or episodic migraine
Must have completed all required visits and procedures in the previous study (Study 19356A or Study 19357A)
Must be able to comply with study procedures and visit schedules
Must have parent or legal guardian consent to participate in the study

Who cannot join the trial?

15 criteria

History of chronic or continuous headache lasting more than 72 hours
Previous failure to respond to 3 or more preventive migraine medications
Presence of other types of headaches that could interfere with the assessment of migraine
Use of opioids (strong pain medications) or barbiturates (sedative medications) more than twice per month
Any major medical condition that could affect the study results
Current diagnosis of cancer or history of cancer in the past 5 years
History of severe allergic reactions to any medications
Pregnancy or breastfeeding
Participation in another clinical trial within the past 30 days
Mental health conditions that could affect the ability to follow study procedures
History of substance abuse within the past year
Any surgical procedure planned during the study period
Inability to comply with study visits and procedures
Use of any prohibited medications within 30 days before the study starts
Children under 6 years or over 17 years of age

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Verified sites

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

Verified
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Verified
Bambino Gesu Childrens Hospital
Rome, Italy
Verified
Centro Hospitalar E Universitario De Coimbra E.P.E.
Coimbra, Portugal

Trial locations

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Investigated drugs

Eptinezumab is a medication used to prevent migraines. It belongs to a class of drugs called CGRP inhibitors, which work by blocking a protein involved in causing migraine headaches. This medication is given as an intravenous infusion (through a vein) and is being studied for its effectiveness and safety in children and teenagers who suffer from frequent or chronic migraine headaches. The medication aims to reduce the number of migraine days that patients experience each month.

Eptinezumab

What is already known about the treatment

Eptinezumab – An innovative monoclonal antibody medication administered through intravenous infusion, specifically designed for migraine prevention in both chronic and episodic cases. This biological drug works by targeting and blocking the calcitonin gene-related peptide (CGRP), a protein involved in pain transmission and inflammation during migraine attacks. Currently undergoing clinical trials for use in pediatric populations aged 6-17 years, eptinezumab belongs to the class of CGRP antagonists and represents a significant advancement in preventive migraine treatment, with established safety and efficacy data in adults and ongoing research in younger populations. The medication is particularly notable for its long-lasting effects and ability to reduce both the frequency and severity of migraine episodes.

Investigated diseases

Migraine - A neurological condition characterized by recurring headaches that typically affect one side of the head and are accompanied by various symptoms. The pain is often described as throbbing or pulsating and can last from several hours to days. Common accompanying symptoms include sensitivity to light, sound, and smells, as well as nausea and vomiting. Migraines can be triggered by various factors including stress, certain foods, hormonal changes, or environmental stimuli. The condition can occur as episodic (occasional) or chronic (frequent) attacks.