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Study on 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 treatment of migraine in children and adolescents aged 6 to 18 years. The treatment being tested is a medication called rimegepant, which is taken orally in the form of a lyophilisate, a type of medication that dissolves in the mouth. The study will compare the effects of rimegepant with a placebo to understand its effectiveness in providing relief from migraine symptoms.

The purpose of the study is to evaluate how well rimegepant works in treating acute migraine attacks, which can occur with or without aura. Aura refers to visual or sensory disturbances that some people experience before a migraine headache. Participants in the study will receive either rimegepant or a placebo and will be monitored to see if they experience pain relief and freedom from other bothersome symptoms like nausea, sensitivity to light (photophobia), and sensitivity to sound (phonophobia) within two hours of taking the medication.

The study will take place over a period of time, during which participants will be asked to report their symptoms and any changes they experience. The goal is to determine if rimegepant can help reduce the severity and duration of migraine attacks in young people, allowing them to return to their normal activities more quickly. The study will also assess whether participants need additional medication to manage their symptoms after taking the study medication.

1 Enrollment

Upon joining the study, participants are enrolled based on specific criteria, including age and medical history related to migraines.

Participants must have a history of migraines for more than six months and experience one to eight moderate or severe attacks per month.

2 Baseline Visit

Participants attend a baseline visit where initial assessments are conducted.

This includes confirming the participant’s ability to distinguish between migraine and other types of headaches.

3 Single-Blind Placebo Phase

Participants receive a placebo treatment to establish a baseline response.

This phase helps in understanding the natural course of migraine attacks without active medication.

4 Double-Blind Treatment Phase

Participants are randomly assigned to receive either rimegepant or a placebo.

Rimegepant is administered as an oral lyophilisate, with dosages of either 25 mg or 75 mg.

5 Assessment of Pain Freedom

Pain freedom is evaluated at 2 hours after taking the double-blind treatment.

Participants report their pain level using a numeric scale, with the goal of achieving no pain.

6 Monitoring and Follow-Up

Participants are monitored for any side effects and the need for rescue medication is assessed.

Follow-up assessments occur to evaluate sustained pain freedom and the ability to function normally.

7 Completion of Study

The study concludes with a final evaluation of the participant’s response to the treatment.

Data collected throughout the study is analyzed to determine the efficacy and safety of rimegepant.

Who Can Join the Study?

  • The participant must be able to communicate with the study staff and understand the information provided about the study.
  • The participant and their parent(s) or legal representative(s) must sign a form agreeing to participate in the study before any study-related activities begin.
  • The participant and their parent(s) or legal representative(s) must be willing to attend study appointments as scheduled.
  • The participant must be able to read and understand written instructions and complete questionnaires with the help of their legal representative(s) if needed.
  • The participant must have a history of migraines, with or without aura, for more than 6 months before joining the study. Aura refers to visual or sensory disturbances that can occur before a migraine.
  • The participant must have experienced 1 to 8 moderate or severe migraine attacks per month in the 2 months before joining the study. These attacks should last more than 3 hours without treatment.
  • 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 it 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 start of the study.
  • 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 during the study.
  • If the participant is a female who has started menstruating or a male who is sexually active, they must agree to use effective birth control methods to prevent pregnancy during the study and for 60 days after taking the study medication.
  • 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 their participation in the study. If there are any abnormalities, the study doctor must determine that they are not significant and will not pose additional risks or interfere with the study.

Who Cannot Join the Study?

  • Patients who have a history of allergic reactions to the study medication or similar medications. An allergic reaction is when your body reacts badly to something, causing symptoms like rash, itching, or trouble breathing.
  • Patients who are currently taking other medications that might interfere with the study medication. This means if you are on certain drugs that could affect how the study drug works, you might not be able to join.
  • Patients with certain medical conditions that could make it unsafe to participate. Medical conditions are health problems or diseases you might have.
  • Patients who are pregnant or breastfeeding. This is because the study medication might affect the baby.
  • Patients who have participated in another clinical trial recently. This is to ensure that previous study drugs do not affect the results of this study.
  • Patients who are unable to follow the study procedures. This means if you cannot do what the study requires, like taking the medication as instructed or attending appointments, you might not be able to join.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Hospital Clinico Universitario De Valladolid Valladolid Spain
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
ProbarE i Lund AB Lund Sweden
ProbarE i Stockholm AB Stockholm Sweden
Wojewodzki Specjalistyczny Szpital Dzieciecy Im Sw Ludwika W Krakowie Cracow Poland
Virgen del Rocío University Hospital Sevilla Spain
Centrum Leczenia MIGRE Wroclaw Poland
Hadfbomd Vdec dxcpmsgh Barcelona Spain

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

Trial status

Country Status Recruitment Start
Poland Poland
Recruiting
08.01.2021
Spain Spain
Recruiting
08.01.2021
Sweden Sweden
Recruiting
08.01.2021

Trial locations

Investigated drugs:

Rimegepant is a medication being studied for its effectiveness in treating migraines in children and adolescents aged 6 to 18 years. It is designed to help relieve migraine symptoms, including headache pain, within a few hours after taking the dose. The trial aims to determine how well this medication works in providing pain relief compared to not taking any active medication.

Investigated diseases:

Acute Migraine (with or without aura) – Acute migraine is a neurological condition characterized by intense, throbbing headaches, often on one side of the head. It can occur with or without aura, which are sensory disturbances like visual flashes or tingling sensations that precede the headache. The headache phase can last from a few hours to several days and is often accompanied by nausea, vomiting, and sensitivity to light and sound. During an attack, individuals may experience a need to rest in a dark, quiet room. The frequency and severity of migraines can vary widely among individuals.

Trial ID:
2024-512743-23-00
Protocol code:
C4951002
Trial Phase:
Therapeutic confirmatory (Phase III)

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