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

Site Name City Country Status
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Lille Lille France
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia Bucharest Romania

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Clinico Universitario De Valladolid Valladolid Spain
Hopital Purpan Toulouse France
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Azienda Sanitaria Locale Bari Bari Italy
Hudvnhnj Vsai dhzgjxzl Barcelona Spain
Vmrseu dgy Rgbvj Uokqoarfcs Hmjbdmry Sevilla Spain
Azorhqemnn Ptqfxira Hcjwmcoy Dt Mlksiumur Marseille France
Awarjsj Obvysbtcego Uugxpspxmflye Feijebxw Il Dw Nvhhgj Naples Italy
Mydtdef Crfxct &ithjxk Ulpipkblww Om Fhimdslr Freiburg Im Breisgau Germany
Cjexgi Hynbxuoeley Uvndhqokzcxdg Askzwr Pkkkjqda Amiens France
Hcddgelc Dz Lv Sgwwb Cbsh I Syam Pdu Barcelona Spain
Hywksxke Suoh Jhul Dz Dbx Borbfiupx Esplugues De Llobregat Spain
Hjtdghka Ukwyuxgjxljxo 1i Dj Owyzpbx Madrid Spain
Vfrtz Uvtgybfvfmzx Bsxacib Jette Belgium
Oyolbokl Pcvpqrktzm Bqttfjc Gblelhbsxbd Rome Italy
Fgigyphnmk Ijjuowstkk Ijfsilmy Nmxveaweish Bzsxt Milan Italy
Hbjyzvax Uxcujibwpyfcny Sscnqofkjy &ncslud Hjiiegk de Hfwktcdinqn STRASBOURG, Alsace France
Pziu Tbbic Hrleqkxw Upuxybvffzsv Sabadell Spain
Zmdohxg fkwd kkdmugbqr Fmdamhkjp Dfy Iq Stuenro Geso Bad Homburg Germany
Spfiuaer Cjdhkw Dg Utljsba Pqkuob Cxsde Shixju Mvevz Ibtb Iasi Romania
Hiprmoxm Ujsxttjdsskjt Qzpesgdnfom Muhodm Pozuelo De Alarcon Spain
Sjwxyljm Cnzvbt Jgpicjdd Ds Ujhgizp Syulqps Ahaubjz Awcbgo Cwhglgbci Constanta Romania
Apggsrshkw Pauiitok Hzpwkima Dr Pzxan Paris France
Zsvtaytcfi Ongq Lyhfqfx Genk Belgium
Aennvaa Ocjxivnprgh Upuzfeersaozs Mfiuy Imlmu Florence Italy
Fnnolbomry Ioxhwdbw Nfcbzcakvyq Nfaqbrgzk Carnzput Mhkmlpg Pavia Italy
Ierbo Kdjsptqqa Sljoupdgn Zwolle The Netherlands
Sli Jtbhtntmfukqdj Bochum Germany
Cmgxpz Hmqbqawclea Ixmzddbxwlsiw dt Mpjysbaepyznhv ev dx Pmza dll Sbyznho Mont-de-Marsan 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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