Study on 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 effectiveness and safety of a medication called lasmiditan for treating migraine in children aged 6 to 17. Migraines are severe headaches that can cause intense throbbing or pulsing sensations, often accompanied by nausea, vomiting, and sensitivity to light and sound. The study aims to determine if lasmiditan can help relieve these symptoms in young patients.

Participants in the study will be randomly assigned to receive either lasmiditan or a placebo, which is a tablet that looks like the medication but does not contain the active ingredient. The study will last up to 20 weeks and may involve up to four visits. During this time, researchers will monitor the participants to see how well the treatment works and if there are any side effects.

The main goal of the study is to see if lasmiditan can provide pain relief for children experiencing migraines. This research is important because it could lead to new treatment options for young people who suffer from these debilitating headaches. The study is conducted in a way that ensures the safety and well-being of all participants throughout the trial period.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose, which is to evaluate the safety and effectiveness of lasmiditan in children aged 6 to 17 with migraine.

The study is designed to last up to 20 weeks and may include up to 4 visits.

2 medication administration

Participants will receive lasmiditan in tablet form for oral use. The specific dosage will be determined by the study protocol.

The medication is intended for the acute treatment of migraine attacks.

3 monitoring and visits

Throughout the study, participants will attend up to 4 visits. These visits are scheduled to monitor the participant’s response to the medication and to ensure safety.

During these visits, participants will be assessed for any changes in their migraine symptoms and overall health.

4 evaluation of outcomes

The primary outcome of the study is to measure the percentage of participants who achieve pain freedom after taking a high dose of lasmiditan.

This evaluation will help determine the effectiveness of the medication in treating migraine in the pediatric population.

Who Can Join the Study?

Participants must have a history of migraine, which is a type of headache that can cause severe pain, with or without aura. An aura is a visual or sensory disturbance that some people experience before a migraine.
Participants should have had migraine attacks for more than 6 months.
Participants should report having at least 2 but no more than 8 moderate-to-severe migraine attacks per month in the 2 months before the screening visit.
The typical untreated migraine attack should last 3 hours or more, not counting time spent sleeping.
Participants should not have had a satisfactory response to previous migraine treatments, according to the investigator’s opinion.
Participants must be able to swallow a tablet.
If participants are taking medication to prevent migraines, their treatment plan should be stable and have been followed for at least 3 months before the screening.
Participants must weigh at least 15 kilograms (kg), which is about 33 pounds.

Who Cannot Join the Study?

Children who do not have a diagnosis of migraine cannot participate. A migraine is a type of headache that can cause severe pain, often accompanied by nausea and sensitivity to light and sound.
Children younger than 6 years old or older than 17 years old are not eligible.
Children who have other medical conditions that might interfere with the study may be excluded.
Children who are taking certain medications that could affect the study results might not be able to participate.
Children who have had a recent surgery or are planning to have surgery during the study period may be excluded.
Children who are unable to attend all required study visits might not be eligible.
Children who have participated in another clinical trial recently may not be allowed to join this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia	Bucharest	Romania
Centre Hospitalier Intercommunal Creteil	Creteil	France

Other Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Isala Klinieken Stichting	Zwolle	The Netherlands
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Canisius Wilhelmina Ziekenhuis	Nijmegen	The Netherlands
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH	Bad Homburg	Germany
Azienda Sanitaria Locale Bari	Bari	Italy
Spitalul Clinic De Urgenta Pentru Copii Sfanta Maria Iasi	Iasi	Romania
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta	Constanta	Romania
Assistance Publique Hopitaux De Paris	Paris	France
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Ziekenhuis Oost Limburg	Genk	Belgium
Vrije Universiteit Brussel	Jette	Belgium
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources	Mont-de-Marsan	France
Kexzzp fdu Kznvoqu uvb Jcjyaptyciqbf dvl Rbjejoretswqqwuu Bgnmst ih Scx Jwkbmegshnucgr	Bochum	Germany
Pzzc Tcpux Htccaucf Uvmusuruuavu	Sabadell	Spain
Htwqxtnj Ds Lm Srsyh Cipl I Sujq Pgs	Barcelona	Spain
Hkumiagh Vvec dngjxaus	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	27.03.2020
France	Not recruiting	27.03.2020
Germany	Not recruiting	27.03.2020
Italy	Not recruiting	27.03.2020
Romania	Not recruiting	27.03.2020
Spain	Not recruiting	27.03.2020
The Netherlands	Not recruiting	27.03.2020

Trial locations

Investigated drugs:

Lasmiditan

Lasmiditan is a medication being studied to see if it is safe and effective for treating migraines in children aged 6 to 17. The study aims to determine how well this medication works in relieving migraine symptoms in this age group.

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 sensory 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 migraines that occur frequently. 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:

2023-506253-38-00

Protocol code:

H8H-MC-LAHV

NCT ID:

NCT04396236

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Lasmiditan for Treating Migraine in Children Aged 6 to 17

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