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

3 1 1 1

What is this study about?

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.

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.

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.

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).

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Clinico San Carlos Madrid Spain
Centro Hospitalar Universitario Sao Joao E.P.E. Porto Portugal

Other Sites

Site Name City Country Status
Etg Neuroscience Sp. z o.o. Warsaw Poland
IRCCS Istituto Giannina Gaslini Genoa Italy
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Mtz Clinical Research Powered By Pratia Warsaw Poland
Hospital Cuf Descobertas S.A. Lisbon Portugal
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Athleticomed Sp. z o.o. Bydgoszcz Poland
Azienda Socio Sanitaria Locale N. 8 Di Cagliari Cagliari Italy
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Hospital Alvaro Cunqueiro Vigo Spain
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centrum Leczenia MIGRE Wroclaw Poland
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Eux Lwxobv Lublin Poland
Cznnul Hbgklktfwk E Ukfwrsdjshfkq Dq Clmhcbz Ezltoz Coimbra Portugal
Hutjyrzn Vqaf dajuvukq Barcelona Spain
Ieqixigq Ztuwmhh Dh Bawmpfqeeurooofdd Oświęcim Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
07.03.2023
Poland Poland
Recruiting
07.03.2023
Portugal Portugal
Recruiting
07.03.2023
Spain Spain
Recruiting
07.03.2023

Trial locations

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.

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.

Trial ID:
2022-502917-27-00
Protocol code:
19379A
NCT ID:
NCT05164172
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on Atorvastatin for Preventing Episodic Migraine in Adults

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway
  • Study of incobotulinumtoxinA injections for prevention of chronic migraine in adult patients

    Recruiting

    3 1 1
    Austria Czechia Denmark France Germany Italy +3