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Effekt- og sikkerhedsundersøgelse af Rimegepant til forebyggende behandling af migræne hos pædiatriske forsøgspersoner

13. oktober 2026 opdateret af: Pfizer

Et fase 3, randomiseret, dobbeltblindt, placebokontrolleret studie for at evaluere effektiviteten og sikkerheden af ​​Rimegepant i migræneforebyggelse hos børn og unge ≥ 6 til

The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years with episodic migraine.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

640

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Afsluttet
        • Children's and Women's Health Centre of British Columbia
  • Forenede Stater
    • Arkansas
      • Fort Smith, Arkansas, Forenede Stater, 72901
        • Aktiv, ikke rekrutterende
        • The Belinga Clinic
    • California
      • Hawthorne, California, Forenede Stater, 90250
        • Rekruttering
        • Advanced Investigative Medicine, Inc.
      • La Mesa, California, Forenede Stater, 91942
        • Aktiv, ikke rekrutterende
        • Velocity Clinical Research San Diego
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Aktiv, ikke rekrutterende
        • Colorado Springs Neurological Associates
      • Fort Collins, Colorado, Forenede Stater, 80528
        • Afsluttet
        • Advanced Neurosciences Research, LLC
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20016
        • Rekruttering
        • Velocity Clinical Research, Washington DC
    • Florida
      • Edgewater, Florida, Forenede Stater, 32132
        • Aktiv, ikke rekrutterende
        • Accel Research Sites Network - Edgewater Clinical Research Unit
      • Hialeah, Florida, Forenede Stater, 33012
        • Rekruttering
        • Direct Helpers Research Center
      • Hollywood, Florida, Forenede Stater, 33020
        • Afsluttet
        • New Med Research, Inc
      • Ormond Beach, Florida, Forenede Stater, 32174
        • Aktiv, ikke rekrutterende
        • Complete Health Research
      • Tamarac, Florida, Forenede Stater, 33321
        • Rekruttering
        • D&H Tamarac Research Center LLC
      • Tampa, Florida, Forenede Stater, 33615
        • Rekruttering
        • Santos Research Center, CORP
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912
        • Rekruttering
        • Augusta University
      • Augusta, Georgia, Forenede Stater, 30904
        • Rekruttering
        • Clinical Trial Office
      • Sandy Springs, Georgia, Forenede Stater, 30328
        • Aktiv, ikke rekrutterende
        • WR-Mount Vernon Clinical Research, LLC
      • Savannah, Georgia, Forenede Stater, 31406
        • Aktiv, ikke rekrutterende
        • Meridian Clinical Research, LLC
      • Snellville, Georgia, Forenede Stater, 30078
        • Aktiv, ikke rekrutterende
        • Extraordinary Family Healthcare
      • Snellville, Georgia, Forenede Stater, 30078
        • Aktiv, ikke rekrutterende
        • Renew Health Clinical Research LLC
    • Idaho
      • Boise, Idaho, Forenede Stater, 83704
        • Rekruttering
        • Northwest Clinical Trials, Inc.
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60642
        • Afsluttet
        • Diamond Headache Clinic
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70125
        • Rekruttering
        • Nola Research Works, LLC
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48203
        • Ikke rekrutterer endnu
        • NRST - Detroit
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55402
        • Ikke rekrutterer endnu
        • Clinical Research Institute
    • Mississippi
      • Clinton, Mississippi, Forenede Stater, 39056
        • Afsluttet
        • Safe Haven Clinical Research
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65212
        • Rekruttering
        • University of Missouri
      • Columbia, Missouri, Forenede Stater, 65211
        • Rekruttering
        • Roy Blunt NextGen Precision Health Building
      • Columbia, Missouri, Forenede Stater, 65212
        • Rekruttering
        • University of Missouri-Clinical and Translational Sciences Unit
      • Columbia, Missouri, Forenede Stater, 65212
        • Rekruttering
        • University of Missouri Health Care - Investigation Pharmacy
    • Nebraska
      • Grand Island, Nebraska, Forenede Stater, 68803
        • Rekruttering
        • Velocity Clinical Research, Grand Island
      • Papillion, Nebraska, Forenede Stater, 68046
        • Rekruttering
        • Papillion Research Center/CCT Research
    • Nevada
      • Reno, Nevada, Forenede Stater, 89502
        • Aktiv, ikke rekrutterende
        • Renown Regional Medical Center
    • New York
      • Amherst, New York, Forenede Stater, 14226
        • Aktiv, ikke rekrutterende
        • Dent Neurosciences Research Center, Inc.
      • The Bronx, New York, Forenede Stater, 10461
        • Rekruttering
        • Montefiore Medical Center
    • North Carolina
      • Fayetteville, North Carolina, Forenede Stater, 28303
        • Aktiv, ikke rekrutterende
        • Carolina Institute for Clinical Research, LLC
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45229
        • Rekruttering
        • Cincinnati Children's Hospital Medical Center
      • Cincinnati, Ohio, Forenede Stater, 45242
        • Aktiv, ikke rekrutterende
        • Velocity Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • Aktiv, ikke rekrutterende
        • Lynn Health Science Institute
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29414
        • Aktiv, ikke rekrutterende
        • Coastal Pediatric Research
      • Greenville, South Carolina, Forenede Stater, 29607
        • Afsluttet
        • Tribe Clinical Research LLC
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57108
        • Rekruttering
        • Avera Research Institute
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Rekruttering
        • Avera McKennan Hospital & University Health Center
      • Sioux Falls, South Dakota, Forenede Stater, 57110
        • Rekruttering
        • Avera Medical Group Pediatrics - Dawley Farm
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Afsluttet
        • Monroe Carell Jr Children's Hospital at Vanderbilt
    • Texas
      • Dallas, Texas, Forenede Stater, 75209
        • Rekruttering
        • Alina Clinical Trials, LLC.
      • Frisco, Texas, Forenede Stater, 75034
        • Rekruttering
        • North Texas Center for Clinical Research
      • Houston, Texas, Forenede Stater, 77094
        • Rekruttering
        • NeuroCare Plus
      • Houston, Texas, Forenede Stater, 77065
        • Rekruttering
        • DM Clinical Research - Cy Fair
      • Houston, Texas, Forenede Stater, 77077
        • Rekruttering
        • SCLA Management - Drop Box
      • Houston, Texas, Forenede Stater, 77077
        • Rekruttering
        • SCLA Management Office
      • Lake Jackson, Texas, Forenede Stater, 77566
        • Aktiv, ikke rekrutterende
        • Red Star Research, LLC
      • McAllen, Texas, Forenede Stater, 78503
        • Rekruttering
        • DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials
      • San Antonio, Texas, Forenede Stater, 78258
        • Rekruttering
        • DCT-Stone Oak, LLC dba Discovery Clinical Trials
      • Sherman, Texas, Forenede Stater, 75092
        • Aktiv, ikke rekrutterende
        • Texas Institute for Neurological Disorders
      • Tomball, Texas, Forenede Stater, 77375
        • Rekruttering
        • DM Clinical Research (Administrative Office Only)
      • Victoria, Texas, Forenede Stater, 77901
        • Afsluttet
        • Victoria Clinical Research Group
    • Virginia
      • Portsmouth, Virginia, Forenede Stater, 23703
        • Aktiv, ikke rekrutterende
        • Meridian Clinical Research, LLC
  • Frankrig
      • Créteil, Frankrig, 94000
        • Rekruttering
        • Centre Hospitalier Intercommunal de Creteil
      • Montpellier, Frankrig, 34295
        • Aktiv, ikke rekrutterende
        • Centre Hospitalier Universitaire de Montpellier
      • Toulouse, Frankrig, 31059
        • Rekruttering
        • Hopital des Enfants
  • Italien
      • Brescia, Italien, 25069
        • Rekruttering
        • ASST Spedali Civili di Brescia
    • BARI / Puglia
      • Bari, BARI / Puglia, Italien, 70132
        • Rekruttering
        • UOSVD Centro Epilessia ed EEG dellEta Evolutiva
    • Latina/lazio
      • Latina, Latina/lazio, Italien, 04100
        • Rekruttering
        • Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic
    • Lazio
      • Rome, Lazio, Italien, 00166
        • Rekruttering
        • IRCCS San Raffaele
    • Lombardy
      • Milan, Lombardy, Italien, 20133
        • Rekruttering
        • Istituto Neurologico "Carlo Besta" Fondazione IRCCS
    • Rome/lazio
      • Rome, Rome/lazio, Italien, 00165
        • Rekruttering
        • Divisione di Neurologia, Ospedale Pediatrico Bambino Gesu
  • Japan
    • Fukuoka
      • Kasuga-shi, Fukuoka, Japan, 816-0802
        • Rekruttering
        • Jinnouchi Neurosurgical Clinic
    • Gunma
      • Kiryu-shi, Gunma, Japan, 376-0035
        • Rekruttering
        • Hikita Pediatric Clinic
    • Hyōgo
      • Higashinada-ku Kobe-shi, Hyōgo, Japan, 658-0064
        • Rekruttering
        • Konan Medical Center
      • Nishinomiya-shi, Hyōgo, Japan, 663-8204
        • Rekruttering
        • Yamaguchi Clinic
    • Ibaraki
      • Mito, Ibaraki, Japan, 310-0015
        • Ikke rekrutterer endnu
        • Mito Kyodo General Hospital
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-0052
        • Rekruttering
        • Tanaka Neurosurgery & Headache Clinic
    • Kochi
      • Kochi, Kochi, Japan, 780-0051
        • Rekruttering
        • Atago Hospital
    • Miyagi
      • Taihaku-ku Sendai-shi, Miyagi, Japan, 982-0014
        • Rekruttering
        • Sendai Headache and Neurology Clinic
    • Osaka
      • Abeno-ku Osaka-shi, Osaka, Japan, 545-0053
        • Rekruttering
        • Tennouji Dai Brain Clinic
      • Naniwa-ku, Osaka, Japan, 556-0015
        • Rekruttering
        • Tominaga Clinic
    • Saitama
      • Chuo-ku Saitama-shi, Saitama, Japan, 338-8577
        • Rekruttering
        • Saitama Neuropsychiatric Institute
    • Tokyo
      • Shibuya-ku, Tokyo, Japan, 151-0051
        • Rekruttering
        • Tokyo Headache Clinic
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Rekruttering
        • Tokyo Medical University Hospital
  • Polen
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polen, 61-731
        • Rekruttering
        • Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polen, 31-503
        • Rekruttering
        • Wojewodzki Specjalistyczny Szpital Dzieciecy
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Polen, 52-210
        • Rekruttering
        • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polen, 20-064
        • Rekruttering
        • NZOZ Neuromed M. i M. Nastaj Sp. P.
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 02-172
        • Aktiv, ikke rekrutterende
        • MTZ Clinical Research Powered by Pratia
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Polen, 40-123
        • Aktiv, ikke rekrutterende
        • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
      • Katowice, Silesian Voivodeship, Polen, 40-689
        • Rekruttering
        • Neurologia Slaska Centrum Medyczne
    • WOJ. Mazowieckie
      • Warsaw, WOJ. Mazowieckie, Polen, 02-121
        • Rekruttering
        • Next Stage Sp. Z o.o.
  • Spanien
      • Madrid, Spanien, 28036
        • Rekruttering
        • Instituto de Investigaciones del Sueno
      • Seville, Spanien, 41013
        • Rekruttering
        • Virgen del Rocio Hospital
      • Valencia, Spanien, 46026
        • Rekruttering
        • Hospital Universitario y Politecnico La Fe
    • Barcelona
      • Sabadell, Barcelona, Spanien, 08208
        • Rekruttering
        • Hospital Universitari Parc Tauli
    • Castille and León
      • Valladolid, Castille and León, Spanien, 47003
        • Rekruttering
        • Hospital Clinico Universitario de Valladolid (HCUV)
    • Galicia
      • Vigo, Galicia, Spanien, 36312
        • Rekruttering
        • Hospital Alvaro Cunqueiro

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Subject has at least a 6 month history of migraine (with or without aura) and including the following:

    1. 14 or less headache days per month during the 3 month period prior to the Screening Visit

    2. 6 or more migraine days during the Observation Period

    3. 14 or less headache days during the Observation Period

    4. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of >10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit

    5. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches

    6. Migraine attacks, on average, lasting 4 - 72 hours if untreated

    7. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to <18 years; subjects must be less than 18 at the time of signing assent / consent.

      3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.

Exclusion Criteria:

  1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
  2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
  3. The subject has a history or diagnosis of complications of migraine
  4. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
  5. The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and/or mania are excluded.
  6. History of suicidal behavior or the subject is at risk of self-harm or harm to others.
  7. History of major psychiatric disorder.
  8. The subject has a current diagnosis or history of substance abuse
  9. The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Rimegepant / BHV3000

Rimegepant 75mg or 50mg (2 X 25mg) ODT
Medicin: Rimegepant

Rimegepant 75mg or 50mg (2 X 25mg) ODT

Andre navne:
  • BHV3000
Placebo komparator: Matching Placebo

Matching placebo 75mg or 50mg (2 X 25mg) ODT
Medicin: Placebo

Matching placebo 75mg or 50mg (2 X 25mg) ODT

Andre navne:
  • Matchende placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine
Tidsramme: 3 months (12 weeks)

Reduction from baseline in mean number of migraine days per month
3 months (12 weeks)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Opnåelse af mindst 50 % reduktion fra baseline i gennemsnitlige månedlige migrænedage i løbet af den dobbeltblinde fase hos unge med episodisk migræne
Tidsramme: 3 måneder (12 uger)
3 måneder (12 uger)
Ændring fra baseline i det gennemsnitlige antal migrænedage pr. måned i de første 4 uger (uge 1 til 4) af den dobbeltblindede behandlingsfase hos unge med episodisk migræne.
Tidsramme: Uge 1 til 4 af behandlingen
Uge 1 til 4 af behandlingen
Den gennemsnitlige ændring fra baseline i Pediatric Quality of Life (PedsQL™) totalscore ved uge 12 i den dobbeltblindede behandlingsfase hos unge med episodisk migræne.
Tidsramme: Samlet score i uge 12
Samlet score i uge 12
Ændring fra baseline i det gennemsnitlige antal migrænedage pr. måned over hele forløbet af den dobbeltblindede behandlingsfase hos børn og børn og unge kombineret med episodisk migræne.
Tidsramme: 3 måneder (12 uger)
3 måneder (12 uger)
Change from baseline on the proportion of subjects that have at least a 50% reduction in the mean number of moderate to severe migraine days per month.
Tidsramme: 3 months (12 weeks)

Measured over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.
3 months (12 weeks)
Compare the use of acute migraine-specific medications (triptans) based on the change from baseline in monthly acute migraine specific medication days.
Tidsramme: 3 months (12 weeks)

Measured in each month and over the course of the entire double-blind treatment phase in adolescents, children and adolescents and children combined.
3 months (12 weeks)
Evaluate the safety and tolerability of rimegepant as a preventative treatment for migraine in children and adolescents.
Tidsramme: 72 Weeks

This will be evaluated by the number of subjects with treatment related adverse events by severity.
72 Weeks
Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant.
Tidsramme: 72 Weeks

Measured by discontinuations in treated subjects due to elevated liver function tests.
72 Weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Efterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. februar 2022

Primær færdiggørelse (Anslået)

27. marts 2029

Studieafslutning (Anslået)

30. oktober 2032

Datoer for studieregistrering

Først indsendt

19. november 2021

Først indsendt, der opfyldte QC-kriterier

30. november 2021

Først opslået (Faktiske)

14. december 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BHV3000-315
  • C4951009 (Anden identifikator: Alias Study Number)
  • 2021-005246-15 (Registry Identifier: CTIS (EU))
  • 2024-512382-13-00 (Registry Identifier: CTIS (EU))
  • 2021-005246-15 (EudraCT nummer: CTIS (EU))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner