Study on Rimegepant for Preventing Migraines in Children and Teens Aged 6 to 17

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What is this study about?

This clinical trial is focused on studying the prevention of migraine in children and adolescents aged 6 to under 18 years. Migraine is a type of headache that can cause severe pain, often accompanied by nausea, vomiting, and sensitivity to light and sound. The treatment being tested in this study is called Rimegepant, which is taken as an oral lyophilisate, a form that dissolves in the mouth. The study will compare the effects of Rimegepant with a placebo to see how well it works in reducing the number of migraine days each month.

The purpose of the study is to evaluate the effectiveness and safety of Rimegepant in preventing migraines. Participants will be randomly assigned to receive either Rimegepant or a placebo. The study will last for several weeks, during which participants will take the medication and report the number of migraine days they experience. The goal is to see if Rimegepant can significantly reduce the frequency of migraines compared to the placebo.

Throughout the study, participants will be monitored to ensure their safety and to gather information on how the treatment affects their quality of life. The study aims to provide valuable insights into whether Rimegepant can be an effective preventive treatment for migraines in young people, potentially offering a new option for managing this challenging condition.

1 joining the study

Upon joining the study, the participant will be assessed to ensure they meet the necessary criteria, such as having a history of migraine and being within the age range of 6 to less than 18 years.

Participants must have experienced a certain number of migraine days and have a specific score on the Pediatric Migraine Disability Assessment Scale.

2 observation period

During this period, the participant’s migraine frequency and severity will be monitored to establish a baseline for comparison during the treatment phase.

3 randomization and treatment

Participants will be randomly assigned to receive either rimegepant or a placebo. Rimegepant is administered as a 75 mg oral lyophilisate, which is a form of medication that dissolves in the mouth.

The treatment phase lasts for 12 weeks, during which the participant will take the medication as directed.

4 monitoring and assessment

Throughout the treatment phase, the participant’s migraine days will be recorded to evaluate the effectiveness of the treatment.

The primary goal is to observe a reduction in the number of migraine days per month compared to the baseline.

5 completion of the study

At the end of the 12-week treatment phase, the participant’s overall experience and any changes in their quality of life will be assessed.

The study aims to determine if there is a significant improvement in migraine prevention for those taking rimegepant compared to the placebo.

Who Can Join the Study?

  • The patient must have had migraines for at least 6 months. A migraine is a type of headache that can cause severe pain, often on one side of the head, and may come with other symptoms like nausea or sensitivity to light.
  • The patient should have 14 or fewer headache days per month in the 3 months before the study starts.
  • The patient should have 6 or more migraine days during the observation period of the study.
  • The patient should have 14 or fewer headache days during the observation period.
  • The patient should have a Pediatric Migraine Disability Assessment Scale (PedMIDAS) score between 11 and 50. This score measures how much migraines affect daily activities, with higher scores indicating more disruption.
  • The patient must be able to tell the difference between a migraine and other types of headaches, like tension or cluster headaches.
  • Migraine attacks should last between 4 to 72 hours if not treated.
  • If the patient is taking medication to prevent migraines, the dose must have been stable for at least 3 months before the study and should not change during the study.
  • The patient must be between 6 and less than 18 years old at the time of giving consent to participate.
  • The patient must weigh at least 40 kg (or at least 15 kg for younger children) at the start of the study.

Who Cannot Join the Study?

  • Patients who are not between the ages of 12 and 17 years old cannot participate.
  • Patients who do not have episodic migraine cannot participate. Episodic migraine means having migraine headaches on some days, but not every day.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have a history of drug or alcohol abuse cannot participate.
  • Patients who have had an allergic reaction to the study medication or similar medications cannot participate.

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
Hopital Des Enfants Toulouse France
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Mtz Clinical Research Powered By Pratia Warsaw Poland
Hospital Clinico Universitario De Valladolid Valladolid Spain
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
AORN San Giuseppe Moscati Avellino Avellino Italy
Wojewodzki Specjalistyczny Szpital Dzieciecy Im Sw Ludwika W Krakowie Cracow Poland
Azienda Sanitaria Locale Bari Bari Italy
Irccs San Raffaele Roma S.r.l. Rome Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Hospital Alvaro Cunqueiro Vigo Spain
Virgen del Rocío University Hospital Sevilla Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Universita Degli Studi Di Brescia Brescia Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Centrum Leczenia MIGRE Wroclaw Poland
Nuhd Ssjug Sja z oefz Warsaw Poland
Uzevqfxwwl Lq Skhqpmbt &sulkjs Cfjvmn Apdmgzgkwii Cxeweeiy Izfhhwvs Latina Italy
Pfjj Tzxkk Htuxruhi Udhafjdhczii Sabadell Spain
Uzslaptega Dygxo Spgjo Dl Rslt Lo Sacaojic Rome Italy

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

Trial status

Country Status Recruitment Start
France France
Recruiting
16.12.2022
Italy Italy
Recruiting
16.12.2022
Poland Poland
Recruiting
16.12.2022
Spain Spain
Recruiting
16.12.2022

Trial locations

Investigated drugs:

Rimegepant is a medication being studied for its ability to prevent migraines in children and adolescents aged 6 to 18 years. It is being tested to see if it can reduce the number of migraine days each month. This medication is taken to help manage and prevent the occurrence of migraines, aiming to improve the quality of life for young individuals who experience these headaches frequently.

Investigated diseases:

Migraine – A migraine is a type of headache characterized by intense, throbbing pain, often on one side of the head. It can be accompanied by nausea, vomiting, and sensitivity to light and sound. Migraines can last for hours or even days and may occur with or without an aura, which includes visual disturbances or other sensory changes. The frequency of migraines can vary, with some individuals experiencing them occasionally and others having them more frequently. Over time, migraines can become more predictable in their pattern, but the severity and specific symptoms can differ from one episode to another.

Trial ID:
2024-512382-13-00
Protocol code:
C4951009
NCT ID:
NCT05156398
Trial Phase:
Therapeutic confirmatory (Phase III)

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