Study on the Long-Term Safety of Rimegepant for Treating Acute Migraine in Children and Adolescents Aged 6 to 17 Years

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What is this study about?

This clinical trial is focused on studying the long-term safety and tolerability of a medication called rimegepant for treating migraine in children and adolescents aged 6 to 18 years. Migraines are severe headaches that can occur with or without warning signs known as aura, which might include visual disturbances or other sensory changes. The study involves two forms of the medication: a 25 mg oral lyophilisate and a 75 mg oral lyophilisate, both of which are taken by mouth.

The purpose of the study is to evaluate how safe and well-tolerated rimegepant is when used for the acute treatment of migraines in young people. Participants in the study will take the medication over a period of time, and researchers will monitor them for any side effects or adverse reactions. The study is open-label, meaning that both the participants and the researchers know which treatment is being administered.

Throughout the study, participants will be regularly assessed to ensure their safety and to gather information on any side effects they may experience. The study aims to provide valuable insights into the use of rimegepant for managing migraines in children and adolescents, helping to determine its suitability as a treatment option for this age group.

1 Enrollment

Upon joining the study, the participant will be enrolled after meeting the eligibility criteria. This includes a history of migraine for more than 6 months and experiencing 1 to 8 moderate or severe migraine attacks per month.

Participants must be between 6 and 18 years old and have a weight greater than 40 kg. Female participants of childbearing potential must have a negative pregnancy test and agree to use contraception.

2 Baseline Visit

During the baseline visit, participants will undergo a medical evaluation to ensure no significant abnormalities are present. Blood samples will be taken to establish baseline laboratory values.

Participants will be instructed on how to distinguish between migraine and other types of headaches.

3 Treatment Phase

Participants will receive rimegepant as an oral lyophilisate. The available dosages are 25 mg and 75 mg, administered as needed for acute migraine treatment.

The medication is taken orally, and participants will be monitored for any adverse effects throughout the study.

4 Monitoring and Follow-up

Participants will attend regular follow-up visits to monitor the frequency and severity of any adverse events. These visits will also assess the overall safety and tolerability of the treatment.

Clinically significant laboratory abnormalities will be identified and addressed as necessary.

5 Study Completion

The study is estimated to conclude by September 2025. Upon completion, participants will undergo a final evaluation to assess the long-term safety and tolerability of the treatment.

Who Can Join the Study?

The participant must be able to communicate with the study staff and understand the forms they need to sign. Their parent or legal guardian must also understand and sign the necessary forms.
The participant and their parent or guardian must be willing to attend study appointments as scheduled.
The participant must be able to read and understand written instructions and be willing to complete questionnaires with the help of their guardian if needed.
The participant must have a history of migraines for more than 6 months, with 1 to 8 moderate or severe attacks per month in the last 2 months.
The participant must have experienced at least one migraine day requiring treatment during the observation phase of the study.
If the participant is taking medication to prevent migraines, the dose must have been stable for at least 12 weeks before the study starts and should not change during the study.
The participant must be able to tell the difference between a migraine and other types of headaches.
The participant must weigh more than 40 kg (or more than 15 kg for younger children) at the screening visit.
The participant must have good veins for taking blood samples.
The participant must be between 6 and 18 years old and must not turn 18 before joining the study.
If the participant is a sexually active female who can have children, or a sexually active male, they must agree to use effective birth control methods during the study and for 60 days after taking the study drug.
If the participant is a female who has started menstruating, she must have a negative pregnancy test before starting the study and on the first day of the study.
Females must not be breastfeeding during the study.
The participant must not have any significant medical or laboratory issues that could affect the study.
The study can include up to 200 new adolescent participants, and those who have been in certain previous studies are also eligible.

Who Cannot Join the Study?

Patients who are not between the ages of 6 and 18 years old.
Patients who have medical conditions other than acute migraine (a sudden headache that can be very painful, sometimes with visual disturbances called aura).
Patients who are not able to follow the study procedures or instructions.
Patients who have participated in another clinical trial recently.
Patients who have allergies or reactions to the study medication or similar medications.
Patients who have certain other health problems that the study doctors think might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are taking other medications that might interfere with the study medication.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
Centrum Medyczne Oporow	Wroclaw	Poland
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Clinical Research Center Sp. z o.o. Medic-R sp.k.	Poznan	Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy Im Sw Ludwika W Krakowie	Cracow	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Centrum Leczenia MIGRE	Wroclaw	Poland
Hdabdnpl Vkfg dqeekhlq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	15.03.2021
Spain	Recruiting	15.03.2021

Trial locations

Investigated drugs:

Rimegepant

Rimegepant is a medication being studied for its safety and tolerability in treating acute migraine attacks in children and adolescents aged 6 to 18 years. It is used to relieve migraine headaches, whether or not they are accompanied by aura, which are visual or sensory disturbances that some people experience before a migraine. The study aims to understand how well children and adolescents can tolerate this medication over a long period.

Acute Migraine – Acute migraine is a neurological condition characterized by intense, throbbing headaches, often accompanied by nausea, vomiting, and sensitivity to light and sound. It can occur with or without aura, which are sensory disturbances that can include visual changes or tingling sensations. The headache typically affects one side of the head and can last from a few hours to several days. Migraine attacks can be triggered by various factors such as stress, certain foods, or hormonal changes. The frequency and severity of migraines can vary widely among individuals, with some experiencing occasional episodes and others having frequent, debilitating attacks.

Trial ID:

2024-512744-32-00

Protocol code:

C4951003

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Long-Term Safety of Rimegepant for Treating Acute Migraine in Children and Adolescents Aged 6 to 17 Years

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?