Study on the Safety and Tolerability of Lasmiditan for Treating Migraine in Children Aged 6 to 17

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What is this study about?

This clinical trial is focused on studying the treatment of migraine in children aged 6 to 17. The treatment being tested is a medication called lasmiditan, which is taken as a tablet. The purpose of the study is to evaluate the safety and tolerability of using lasmiditan over a long period for treating migraine attacks in young patients.

Participants in the study will take lasmiditan as needed for their migraine attacks over a 12-month period. The study will monitor how well the medication is tolerated by the participants and will track any side effects that may occur. The study will also look at how many participants stop using the medication due to any adverse effects.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how lasmiditan works in treating migraines in children. This research aims to provide valuable insights into the long-term use of lasmiditan for managing migraines in pediatric patients.

1 joining the study

Upon joining the study, the participant must have completed a previous study and weigh at least 15 kilograms.

The study is designed for children aged 6 to 17 who experience migraines.

2 medication administration

The participant will receive lasmiditan, which is a medication used for treating migraines.

The medication is administered in the form of a tablet and is taken orally.

The use of lasmiditan is intermittent, meaning it is taken as needed for migraine attacks over the course of the study.

3 duration of the study

The study will last for a period of 12 months.

During this time, the safety and tolerability of lasmiditan will be evaluated.

4 monitoring and evaluation

Throughout the study, the occurrence of any adverse events will be monitored.

The primary focus is on the percentage of treatment emergent adverse events and any discontinuations due to adverse events.

Who Can Join the Study?

  • Participants must have completed a previous study, either study H8H-MC-LAHX or study H8H-MC-LAHV. This means they should have been part of one of these studies before joining this one.
  • Participants must weigh at least 15 kilograms (kg). This is about 33 pounds or more.
  • The study is open to both boys and girls.
  • The study includes children, as it is for pediatric participants. Pediatric means it is for children.

Who Cannot Join the Study?

  • Participants who have any other serious health conditions that could interfere with the study.
  • Participants who are currently taking medications that might interact with the study drug.
  • Participants who have had an allergic reaction to similar medications in the past.
  • Participants who are pregnant or breastfeeding.
  • Participants who have a history of substance abuse or addiction.
  • Participants who are unable to follow the study procedures or attend study visits.
  • Participants who have participated in another clinical trial recently.
  • Participants who have a history of certain heart conditions.
  • Participants who have uncontrolled high blood pressure.
  • Participants who have a history of seizures or epilepsy.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Spitalul Clinic De Urgenta Pentru Copii Sfanta Maria Iasi Iasi Romania
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta Constanta Romania
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Ziekenhuis Oost Limburg Genk Belgium
Azienda Sanitaria Locale Bari Bari Italy
Hospital Clinico Universitario De Valencia Valencia Spain
Virgen del Rocío University Hospital Sevilla Spain
Assistance Publique Hopitaux De Paris Paris France
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Isala Klinieken Stichting Zwolle The Netherlands
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
St. Josef-Hospital Bochum Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Vrije Universiteit Brussel Jette Belgium
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Hospital Clinico Universitario De Valladolid Valladolid Spain
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hopital Purpan Toulouse France
Centre Hospitalier Intercommunal de Mont-de-Marsan et du Pays des Sources Mont-de-Marsan France
Pxmw Tlqsw Hzlttaoy Uavlnbgnwzzx Sabadell Spain
Hcmgtham Dy Lv Szgqz Cnth I Sjfh Pgb Barcelona Spain
Zqtrwkm fevn kbpottsoy Fpvraorhu Dbf Ii Szrqdge Gvxw Bad Homburg Germany
Ayplcjkila Pgjqkpcf Hwabxhad Da Mcurgqcmt Marseille France
Hbpcokgr Vusm dbhljqxq Barcelona Spain
Hejzgtss Upwzoxcustbucg Sfhbsqzwgr &squdnn Hkjyyfo df Hweickowdcm STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
27.07.2020
France France
Not recruiting
27.07.2020
Germany Germany
Not recruiting
27.07.2020
Italy Italy
Not recruiting
27.07.2020
Romania Romania
Not recruiting
27.07.2020
Spain Spain
Not recruiting
27.07.2020
The Netherlands The Netherlands
Not recruiting
27.07.2020

Trial locations

Investigated drugs:

Lasmiditan is a medication being studied for its safety and tolerability in treating migraines in children. It is used to relieve migraine attacks when they occur. This study aims to understand how well children can tolerate this medication over a long period when used occasionally to treat their migraine symptoms.

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often on one side of the head. These headaches can be accompanied by nausea, vomiting, and sensitivity to light and sound. Migraine attacks can last for hours to days and may vary in frequency and intensity. Some individuals experience warning symptoms known as aura, which can include visual disturbances or tingling sensations. The exact cause of migraines is not fully understood, but they are believed to involve genetic and environmental factors. Triggers for migraines can include stress, certain foods, hormonal changes, and lack of sleep.

Trial ID:
2023-506724-85-00
Protocol code:
H8H-MC-LAHW
NCT ID:
NCT04396574
Trial Phase:
Therapeutic confirmatory (Phase III)

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