Study of rimegepant for preventing chronic migraine in adolescents aged 12 to 17 years

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What is this study about?

This study focuses on preventing chronic migraine in young people aged 12 to under 18 years. Chronic migraine is a condition where a person experiences headaches on 15 or more days per month, with at least 8 of these being migraine headaches. These migraine attacks typically last between 4 to 72 hours when left untreated and can significantly impact daily life.

The study will test a medication called rimegepant sulfate (also known as PF-07899801), which belongs to a group of medicines called calcitonin gene-related peptide antagonists. This medicine comes as an orodispersible tablet that dissolves in the mouth and is taken by mouth. The purpose is to determine if rimegepant sulfate works better than placebo in preventing migraines in adolescents with chronic migraine.

The study will last several months and will have two parts. In the first part, participants will receive either rimegepant sulfate or placebo without knowing which one they are taking. After this initial phase, there will be an extended period where all participants will receive the active medication. Throughout the study, participants will need to keep track of their headache days and complete questionnaires about how migraines affect their daily activities.

1 Initial observation phase

You will enter an observation phase to document your migraine patterns

During this phase, you will need to record your headache days and migraine days

The observation will confirm if you experience at least 15 headache days and 8 migraine days per month

2 Treatment phase begins

You will be randomly assigned to receive either rimegepant sulfate or a placebo (inactive substance)

The medication will be taken by mouth

This double-blind treatment phase will last for 12 weeks, meaning neither you nor the doctor will know which treatment you are receiving

3 Monitoring during treatment

Throughout the 12-week period, you will need to track:

The number of days you experience migraines

The number of days you use medications for headache relief

The severity of your headaches (moderate or severe)

You will complete quality of life questionnaires at the start and at week 12

4 Open-label extension phase

After the initial 12-week period, you may enter the open-label extension phase

During this phase, all participants will receive the actual medication (rimegepant sulfate)

Your health will continue to be monitored for any side effects or complications

5 Study completion

The study is expected to continue until December 2027

Throughout the study, doctors will monitor your health and any side effects

Your participation will help evaluate if rimegepant sulfate is effective for preventing migraines in adolescents

Who Can Join the Study?

  • Must be between 12 and 17 years old at the time of joining the study
  • For participants from EU countries and India only: Must weigh more than 40 kilograms
  • Must have experienced migraines for at least 6 months
  • Must have 15 or more headache days per month in the 3 months before screening
  • Must have 8 or more migraine days per month in the 3 months before screening
  • Must be able to tell the difference between migraine attacks and other types of headaches
  • Typical migraine attacks must last between 4 and 72 hours when not treated
  • Must be able to understand the study information document
  • Parent or legal guardian must be able to read and understand the consent document
  • Must be willing to complete all required questionnaires under supervision of legal representative
  • Both participant and parent/legal guardian must sign the required consent forms before any study procedures begin

Who Cannot Join the Study?

  • History of any chronic pain condition other than migraine (pain lasting more than 3 months)
  • Previous diagnosis of medication overuse headache (frequent use of pain medications leading to more headaches)
  • Current use of other preventive migraine medications
  • Presence of any severe psychiatric conditions that are not well controlled
  • History of stroke or other serious brain conditions
  • Pregnant or breastfeeding women
  • Active liver disease or abnormal liver function tests
  • History of allergic reactions to similar medications
  • Use of certain medications that might interact with the study drug
  • Participation in another clinical trial within the past 30 days
  • Uncontrolled high blood pressure
  • History of substance abuse within the past year
  • Serious heart conditions or abnormal heart rhythm
  • Unable to follow study procedures or complete headache diary
  • Any condition that, in the investigator’s opinion, makes participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Kuopio University Hospital Kuopio Finland
Hospital Universitario Y Politecnico La Fe Valencia Spain
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p. Lublin Poland
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Univerzitna Nemocnica Martin Martin Slovakia
Athleticomed Sp. z o.o. Bydgoszcz Poland
Hospital Clinico Universitario De Valladolid Valladolid Spain
Specjalistyczne Gabinety Sp. z o.o. Cracow Poland
OHA-Med Sp. z o.o. Warsaw Poland
Narodny Ustav Detskych Chorob Bratislava Slovakia
Azienda Sanitaria Locale Bari Bari Italy
Hospital Universitario Hm Puerta Del Sur Mostoles Spain
Balassagyarmati Dr. Kenessey Albert Korhaz Rendelointezet Balassagyarmat Hungary
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
University Of Debrecen Debrecen Hungary
Neurosphera Sp. z o.o. Warsaw Poland
Virgen del Rocío University Hospital Sevilla Spain
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Semmelweis University Budapest Hungary
Irccs San Raffaele Roma S.r.l. Rome Italy
Turku University Hospital Turku Finland
Pirkanmaan hyvinvointialue Tampere Finland
Hospital Alvaro Cunqueiro Vigo Spain
Universita Degli Studi Di Brescia Brescia Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Fakultni Thomayerova nemocnice Prague Czechia
University Hospital Ostrava Ostrava Czechia
Centrum Leczenia MIGRE Wroclaw Poland
Suomen Terveystalo Oy Tampere Finland
Ic Mqnvw syqydt Bardejov Slovakia
Aheflds Swevgbokd Lrpclk Arpalnfn Sxsulis Lqwvgpegmmzxkt L'aquila Italy
Dtuzuf natzdkqf spccal Lamac Slovakia
Dkiocv Fwaaozhw Nryffvexj S Prylixxighfd Boowiv Bwsgcpzm Banska Bystrica Slovakia
Cuub Df Czde Ayitmuvhigt Ihsoyslk Crcpisuqin Opjvdvslix Tzljnbziozpyjn Mjilg Pwyrwvmo Latina Italy
Smhmod Ticzjhmdwuf Ob Oulu Finland
Mtoqjkes Sug z ocxv Wroclaw Poland
Ksbwuvzo Dxbycrtl Kafovy Nagykanizsa Hungary
Ctqhypy Mryruima Hxab Cxxyre Lublin Poland
Fpuesbyy nyatzqyps Myixe a Hwhhwvv Prague Czechia
Hyimtmll Uwjqoqjfvi Cinkimj Hekvgkmy Helsinki Finland
Unvqboadlw Dlmfb Sqvoh Dw Rszd Lr Segemqyb Rome Italy
Hnasykhe Vpbr ddivrgrq Barcelona Spain
Wyy Wfviep Isj Pjxfz Poqtfzpf Ksgakrk Warsaw Poland
Sanijq Trzyrsmwgqo Oe Turku Finland
Kekzfgsuv sirfwc Dubnica nad Váhom Slovakia

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
16.12.2024
Finland Finland
Not recruiting
16.12.2024
Hungary Hungary
Not recruiting
16.12.2024
Italy Italy
Not recruiting
16.12.2024
Poland Poland
Not recruiting
16.12.2024
Slovakia Slovakia
Not recruiting
16.12.2024
Spain Spain
Not recruiting
16.12.2024

Trial locations

Rimegepant is a medication used to prevent migraine headaches. It belongs to a class of drugs called CGRP receptor antagonists. This medication works by blocking specific proteins in the brain that are involved in causing migraine pain. It is being studied as a preventive treatment for chronic migraines in adolescents, which means it’s taken regularly to reduce how often migraines occur and how severe they are, rather than just treating migraine attacks when they happen.

Placebo is an inactive substance that looks exactly like the real medication but contains no active drug. It is used in this study to help determine how effective rimegepant is by comparing the results between patients who receive the actual medication and those who receive the placebo.

Investigated diseases:

Chronic Migraine – A neurological condition characterized by headaches occurring 15 or more days per month, with at least 8 of those being migraines, for more than three months. The headaches typically cause pulsating or throbbing pain, often on one side of the head. Patients may experience nausea, sensitivity to light and sound, and visual disturbances called auras. The condition can fluctuate in intensity throughout the month, with some headaches being more severe than others. The frequent headaches can significantly impact daily activities and quality of life.

Trial ID:
2023-505601-16-00
Protocol code:
C4951013
Trial Phase:
Therapeutic confirmatory (Phase III)

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