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Skuteczność i tolerancja rymegepantu w zapobieganiu migrenie u dorosłych z niewystarczającą odpowiedzią na doustne leki zapobiegawcze w wywiadzie

29 kwietnia 2026 zaktualizowane przez: Pfizer

Faza 4, randomizowane, podwójnie zaślepione, kontrolowane placebo badanie oceniające skuteczność i tolerancję rymegepantu w zapobieganiu migrenie u dorosłych z niewystarczającą odpowiedzią na doustne leki zapobiegawcze w wywiadzie

Niniejsze badanie jest prowadzone w celu oceny skuteczności i tolerancji rymegepantu w profilaktyce migreny u dorosłych z niewystarczającą odpowiedzią na doustne leki zapobiegawcze w wywiadzie

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

962

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Australia
    • Queensland
      • Sippy Downs, Queensland, Australia, 4556
        • USC Clinical Trials Sunshine Coast
  • Austria
      • Klagenfurt, Austria, 9020
        • Klinikum Klagenfurt Am Worthersee
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medical University Innsbruck
  • Belgia
      • Antwerp, Belgia, 2610
        • GZA Ziekenhuizen
      • Bruges, Belgia, 8000
        • AZ Sint-Jan Brugge-Oostende AV
      • Hasselt, Belgia, 3500
        • Jessa Ziekenhuis
      • Liège, Belgia, 4000
        • Clinique de la Citadelle
      • Saint Nicolas Province de Liège, Belgia, 4420
        • Cabinet Privé Dr. Simona Sava
    • Brussels Capital
      • Jette, Brussels Capital, Belgia, 1090
        • UZ Brussel
  • Dania
      • Esbjerg, Dania, DK-6700
        • University Hospital of Southern Denmark
      • Viborg, Dania, DK-8800
        • Hospitalsenhed Midt
    • Capital Region
      • Copenhagen NV, Capital Region, Dania, 2400
        • Bispebjerg Hospital
      • Glostrup Municipality, Capital Region, Dania, 2600
        • Danish Headache Center
  • Finlandia
      • Tampere, Finlandia, 33100
        • Terveystalo Tampere
      • Turku, Finlandia, 20100
        • Terveystalo Pulssi
    • Uusimaa
      • Helsinki, Uusimaa, Finlandia, 00180
        • Terveystalo Ruoholahti
  • Hiszpania
      • Barcelona, Hiszpania, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Hiszpania, 08006
        • Hospital Clinic de Barcelona Plato Headquarters
      • Madrid, Hiszpania, 28040
        • Hospital Universitario Fundación Jiménez Díaz
      • Madrid, Hiszpania, 28046
        • Hospital Universitario La Paz
      • Madrid, Hiszpania, 28006
        • Hospital Universitario de La Princesa
      • Madrid, Hiszpania, 28050
        • Hospital Universitario HM Sanchinarro
      • Salamanca, Hiszpania, 28006
        • Hospital Universitario Ruber Juan Bravo
      • Santander, Hiszpania, 39008
        • University Hospital Marqués de Valdecilla
      • Seville, Hiszpania, 41013
        • Virgen del Rocío University Hospital
      • Seville, Hiszpania, 41009
        • Hospital Universitario Virgen Macarena
      • Valencia, Hiszpania, 46010
        • Hospital Clínico Universitario de Valencia
      • Valencia, Hiszpania, 46014
        • Consorcio Hospital General Universitario
      • Valladolid, Hiszpania, 47010
        • Hospital Clínico Universitario de Valladolid
    • Alicante
      • Elda, Alicante, Hiszpania, 03600
        • Hospital Universitario de Elda
  • Kanada
      • Québec, Kanada, G2J 0C4
        • Alpha Recherche Clinique
    • Ontario
      • Brampton, Ontario, Kanada, L6T 0G1
        • Aggarwal and Associates Limited
      • Brampton, Ontario, Kanada, L6V 1C2
        • NeuPath Centre for Pain and Spine
    • Quebec
      • Lévis, Quebec, Kanada, G6W0M5
        • Centre de Recherche Saint-Louis/Clinique Neuro-Levis
      • Québec, Quebec, Kanada, G3K 2P8
        • Alpha Recherche Clinique
  • Meksyk
      • Aguascalientes, Meksyk, 20116
        • Centro de Investigación Médica de Aguascalientes (CIMA)
      • Mexico City, Meksyk, CDMX 06700
        • Clinstile, SA de CV
      • Mexico City, Meksyk, CP 14050
        • Operadora Unidad de Investigación En Salud de Chihuahua, Sa de Cv
    • State of Mexico
      • Cuautitlán Izcalli, State of Mexico, Meksyk, 54769
        • Phylasis Clinicas Research S. de R.L. de C.V.
      • Tlalnepantla, State of Mexico, Meksyk, C.P. 54055
        • Clinical Research Institute S.C.
    • Yucatán
      • Mérida, Yucatán, Meksyk, CP. 97070
        • Medical Care and Research S.A. de C.V.
  • Niemcy
      • Berlin, Niemcy, 12672
        • Synexus - Prüfzentrum Berlin
      • Ulm Baden-Wuerttemberg, Niemcy, 89073
        • Neuropoint GmbH
    • Baden-Wurttemberg
      • Göppingen, Baden-Wurttemberg, Niemcy, 73033
        • Schmerz- und Palliativzentrum Göppingen
    • Hesse
      • Bad Homburg, Hesse, Niemcy, 61350
        • Zentrum für klinische Forschung
      • Frankfurt am Main, Hesse, Niemcy, 65929
        • Kopfschmerzzentrum Frankfurt
      • Frankfurt am Main, Hesse, Niemcy, 60313
        • Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre
      • Wiesbaden, Hesse, Niemcy, 65189
        • Intermed GmbH
    • Lower Saxony
      • Westerstede, Lower Saxony, Niemcy, 26655
        • Studienzentrum Nordwest
    • Saxony
      • Leipzig, Saxony, Niemcy, 04103
        • Synexus - Prüfzentrum Leipzig
  • Polska
      • Katowice, Polska, 40-748
        • Vita Longa Sp. z o.o.
      • Katowice, Polska, 40-081
        • Centrum Medyczne Pratia Katowice
      • Szczecin, Polska, 70-784
        • MICS Centrum Medyczne Szczecin
      • Warsaw, Polska, 02-172
        • MTZ Clinical Research Powered by PRATIA
      • Wroclaw, Polska, 52-416
        • Centrum Medyczne Oporow
      • Wroclaw, Polska, 50-414
        • Premium Clinic Wrocław
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polska, 85-163
        • Centrum Medyczne NEUROMED
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Polska, 52-210
        • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
    • Lubusz Voivodeship
      • Nowa Sól, Lubusz Voivodeship, Polska, 67-100
        • Twoja Przychodnia Nowosolskie Centrum Medyczne
    • Malopolska
      • Krakow, Malopolska, Polska, 31-530
        • CenterMed Kraków Sp. z o.o.
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polska, 00-773
        • Concept Medica
      • Warsaw, Masovian Voivodeship, Polska, 02-739
        • MICS Centrum Medyczne Damiana Walbrzyska
      • Warsaw, Masovian Voivodeship, Polska, 01-018
        • Dr Sękowska Leczenie Bólu
    • Małopolska
      • Oświęcim, Małopolska, Polska, 32-600
        • Instytut Zdrowia
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Polska, 91-363
        • Centrum Leczenia Bolu dr n med Lukasz Kmieciak
  • Stany Zjednoczone
    • California
      • Los Angeles, California, Stany Zjednoczone, 90048
        • Clinical Research Institute
      • Sherman Oaks, California, Stany Zjednoczone, 91403
        • California Neuroscience Research, LLC
    • Connecticut
      • Stamford, Connecticut, Stany Zjednoczone, 06905
        • Ki Health Partners LLC, dba New England Institute for Clinical Research
    • Florida
      • Edgewater, Florida, Stany Zjednoczone, 32132
        • Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit
      • Lake City, Florida, Stany Zjednoczone, 32055
        • Wr-Msra,Llc
      • Miami, Florida, Stany Zjednoczone, 33126
        • AppleMed Research Group, LLC
      • Ocoee, Florida, Stany Zjednoczone, 34761
        • Sensible Healthcare LLC
      • Ormond Beach, Florida, Stany Zjednoczone, 32174
        • Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02131
        • Boston Clinical Trials
      • Marlborough, Massachusetts, Stany Zjednoczone, 01752
        • Community Clinical Research Network, Inc.
    • Michigan
      • Ann Arbor, Michigan, Stany Zjednoczone, 48104
        • Michigan Headache & Neurological Institute
      • Rochester Hills, Michigan, Stany Zjednoczone, 48307
        • Rochester Medical Group
    • Missouri
      • Springfield, Missouri, Stany Zjednoczone, 65807
        • Clinvest Research, LLC
      • Weldon Spring, Missouri, Stany Zjednoczone, 63304
        • St Charles Clinical Research
    • Nevada
      • Las Vegas, Nevada, Stany Zjednoczone, 89118
        • Wr-Crcn, Llc
    • New Mexico
      • Albuquerque, New Mexico, Stany Zjednoczone, 87102
        • Albuquerque Clinical Trials. Inc.
    • New York
      • North Massapequa, New York, Stany Zjednoczone, 11758
        • DiGiovanna Institute for Medical Education and Research
    • North Carolina
      • Greensboro, North Carolina, Stany Zjednoczone, 27405
        • Headache Wellness Center, PC
    • South Carolina
      • Anderson, South Carolina, Stany Zjednoczone, 29621
        • Synexus Clinical Research US, Inc. - Anderson
    • Tennessee
      • Knoxville, Tennessee, Stany Zjednoczone, 37909
        • Alliance for Multispecialty Reseach, LLC
    • Texas
      • Lake Jackson, Texas, Stany Zjednoczone, 77566
        • Red Star Research, LLC
      • Tomball, Texas, Stany Zjednoczone, 77375
        • DM Clinical Research
    • Washington
      • Bellevue, Washington, Stany Zjednoczone, 98007
        • Northwest Clinical Research Center
  • Szwecja
      • Gothenburg, Szwecja, 40545
        • Carlanderska Hospital
      • Lund, Szwecja, 222 22
        • Skåneuro Privatmottagning
      • Stockholm, Szwecja, 112 39
        • Hälsoklustret
      • Stockholm, Szwecja, 117 27
        • Akardo Med Site
      • Uppsala, Szwecja, 75185
        • University Hospital Uppsala (VO Neuro)
    • Stockholms LÄN [se-01]
      • Solna, Stockholms LÄN [se-01], Szwecja, 171 64
        • CTC Solna
    • Uppsala LÄN [se-03]
      • Uppsala, Uppsala LÄN [se-03], Szwecja, 752 37
        • CTC MTC
  • Włochy
      • Florence, Włochy, 50134
        • SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
      • Milan, Włochy, 20133
        • IRCCS Fondazione Besta
      • Modena, Włochy, 41124
        • University Modena e Reggio Emilia
    • Lombardy
      • Pavia, Lombardy, Włochy, 27100
        • IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino
    • MI
      • Milan, MI, Włochy, 20132
        • IRCCS Ospedale San Raffaele
    • Naples
      • Naples, Naples, Włochy, 80134
        • AOU Luigi Vanvitelli
    • Rome/lazio
      • Rome, Rome/lazio, Włochy, 00163
        • IRCCS San Raffaele
  • Zjednoczone Królestwo
      • Bristol, Zjednoczone Królestwo, BS32 4SY
        • Cognition Health - Bristol
      • London, Zjednoczone Królestwo, SE5 9PJ
        • Kings college london
      • Swinton, Zjednoczone Królestwo, M27 8FF
        • 4 Medical Clinical Solutions
    • Birmingham
      • Edgebaston, Birmingham, Zjednoczone Królestwo, B16 8LT
        • Re: Cognition Health Ltd.
    • EAST Riding
      • Hull, EAST Riding, Zjednoczone Królestwo, HU3 2JZ
        • Hull University Hospitals NHS Trust
    • Essex
      • Ilford, Essex, Zjednoczone Królestwo, IG1 4HP
        • 4 Medical Clinical Solutions London
    • Norfolk
      • Great Yarmouth, Norfolk, Zjednoczone Królestwo, NR31 6LA
        • James Paget University Hospitals NHS Foundation Trust
    • Northamptonshire
      • Corby, Northamptonshire, Zjednoczone Królestwo, NN17 2UR
        • Lakeside Healthcare Group Research
    • Scotland
      • Glasgow, Scotland, Zjednoczone Królestwo, G51 4TF
        • Queen Elizabeth University Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Opis

Kryteria przyjęcia:

  1. Napady migreny trwają dłużej niż 1 rok i zaczynają się przed 50 rokiem życia.
  2. Napady migreny trwające średnio od 4 do 72 godzin, jeśli nie są leczone.
  3. Średnio od 4 do 14 dni z migreną w miesiącu w ciągu 3 miesięcy poprzedzających Wizytę przesiewową (miesiąc definiuje się jako 28 dni dla celów niniejszego protokołu).
  4. Mniej niż 15 dni z bólem głowy (migrenowym lub niemigrenowym) miesięcznie w każdym z 3 miesięcy poprzedzających wizytę przesiewową i podczas fazy przesiewowej.
  5. Pacjenci muszą być w stanie odróżnić napady migreny od napięciowych/klasterowych bólów głowy. Wcześniejsza niewystarczająca odpowiedź, w ciągu 10 lat od wizyty przesiewowej, na środki z 2-4 kategorii uznanych, podawanych doustnie leków przeciwmigrenowych, gdzie co najmniej jeden przykład wcześniejszej niewłaściwej odpowiedzi jest spowodowany brakiem skuteczności lub wcześniejszą nietolerancją (nie przeciwwskazanie).

Kryteria wyłączenia:

  1. Historia klasterowych bólów głowy, migreny podstawnej (migrena z aurą pnia mózgu) lub hemiplegicznej migreny.
  2. Obecne bóle głowy związane z nadużywaniem leków.
  3. 15 lub więcej dni z bólem głowy (migrenowym lub niemigrenowym) miesięcznie w dowolnym okresie 3 miesięcy poprzedzających wizytę przesiewową lub podczas 28-dniowej fazy obserwacji.
  4. Niewystarczająca odpowiedź (z powodu braku skuteczności, wcześniejszej nietolerancji lub przeciwwskazań) na środki z > 4 kategorii uznanych, podawanych doustnie leków przeciwmigrenowych.
  5. Aktywny zespół bólu przewlekłego (taki jak fibromialgia, przewlekły ból miednicy, złożony zespół bólu regionalnego [CRPS]).
  6. Inne zespoły bólowe (w tym neuralgia nerwu trójdzielnego), otępienie lub istotne zaburzenia neurologiczne (inne niż migrena), które w opinii badacza zakłócają ocenę bezpieczeństwa lub skuteczności badania.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo
Lek: Placebo
Dopasowanie placebo do dawkowania co drugi dzień podczas fazy DBT
Eksperymentalny: Rymegepant 75 mg
Lek: Szron
Rimegepant 75 mg tabletka rozpadająca się w jamie ustnej (ODT) przyjmowany co drugi dzień w fazie leczenia metodą podwójnie ślepej próby (DBT)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
Ramy czasowe: Observation phase (28 days prior to randomization), DBT phase (through Month 3 [Week 1 to 12])
A migraine day was defined as any calendar day in which participant (1) had a qualified migraine headache or (2) took acute migraine-specific medication (i.e., triptan, ergotamine, lasmiditan, or ubrogepant) to treat headache or aura. A qualified migraine headache was defined as a migraine with or without aura, lasting for >=30 minutes, met criteria: >=2 of pain features: unilateral location; pulsating quality (throbbing); moderate or severe pain intensity; aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) or >=1 of associated symptoms: nausea and/or vomiting; photophobia and phonophobia. Number of migraine days per month were prorated to 28 days.
Observation phase (28 days prior to randomization), DBT phase (through Month 3 [Week 1 to 12])

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants With >= 50 Percent (%) Reduction From OP in the Number of Moderate or Severe Migraine Days (MD) Per Month Over the Entire DBT Phase (Weeks 1 to 12)
Ramy czasowe: DBT phase (through Month 3 [Week 1 to 12])
Moderate or severe MD: a MD of moderate or severe headache pain intensity. MD: any calendar day in which participant (1) had a qualified migraine headache or (2) took acute migraine-specific medication (i.e., triptan, ergotamine, lasmiditan, or ubrogepant) to treat headache or aura. Qualified migraine headache: migraine with or without aura, lasting for >=30 minutes, met criteria: >=2 of pain features: unilateral location; pulsating quality (throbbing); moderate or severe pain intensity; aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) or >=1 of associated symptoms: nausea and/or vomiting; photophobia and phonophobia. Number of moderate or severe MD per month were prorated to 28 days and derived from data in the on-DBT efficacy analysis period as follows: 28*(total number of moderate or severe MD through Month 3 [Weeks 1 to 12])/(total number of e-diary efficacy data days through Month 3 [Weeks 1 to 12]).
DBT phase (through Month 3 [Week 1 to 12])
Mean Change From OP in the Number of Migraine Days Per Month in the First 4 Weeks (Weeks 1 to 4) of the DBT Phase
Ramy czasowe: Observation phase (28 days prior to randomization), Week 1 to Week 4 of the DBT phase
A migraine day was defined as any calendar day in which participant (1) had a qualified migraine headache or (2) took acute migraine-specific medication (i.e., triptan, ergotamine, lasmiditan, or ubrogepant) to treat headache or aura. A qualified migraine headache was defined as a migraine with or without aura, lasting for >=30 minutes, met criteria: >=2 of pain features: unilateral location; pulsating quality (throbbing); moderate or severe pain intensity; aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) or >=1 of associated symptoms: nausea and/or vomiting; photophobia and phonophobia. Number of migraine days per month were prorated to 28 days.
Observation phase (28 days prior to randomization), Week 1 to Week 4 of the DBT phase
Mean Change From OP in the Number of Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of the DBT Phase
Ramy czasowe: Observation phase (28 days prior to randomization), Week 9 to Week 12 of the DBT phase
A migraine day was defined as any calendar day in which participant (1) had a qualified migraine headache or (2) took acute migraine-specific medication (i.e., triptan, ergotamine, lasmiditan, or ubrogepant) to treat headache or aura. A qualified migraine headache was defined as a migraine with or without aura, lasting for >=30 minutes, met criteria: >=2 of pain features: unilateral location; pulsating quality (throbbing); moderate or severe pain intensity; aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) or >=1 of associated symptoms: nausea and/or vomiting; photophobia and phonophobia. Number of migraine days per month were prorated to 28 days.
Observation phase (28 days prior to randomization), Week 9 to Week 12 of the DBT phase
Mean Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) Version 2.1 Restrictive Role Function Domain Score at Week 12 of the DBT Phase
Ramy czasowe: Baseline (Day 1) and Week 12 of the DBT phase
MSQ version 2.1 was a self-administered, 14-item instrument validated in 3 domains: role function-restrictive (7 items), role function-preventive (4 items), emotional function (3 items). The restrictive role function domain consisted of 7 items that described how migraine limited one's daily social and work-related activities. Each item was scored on a 6-point scale ranging from 1 to 6, where "1: none of the time," "2: a little bit of the time," "3: some of the time," "4: a good bit of the time," "5: most of the time," and "6: all of the time,". Item scores were recoded using (7 - original score). Raw dimension scores for restrictive role function domain were computed as a sum of recoded item scores and rescaled from a 0 to 100 scale such that lower score (0) indicated poor quality of life and higher scores (100) indicated better quality of life.
Baseline (Day 1) and Week 12 of the DBT phase
Mean Change From Baseline in the Migraine Interictal Burden Scale (MIBS) Score at Week 12 of the DBT Phase
Ramy czasowe: Baseline (Day 1) and Week 12
MIBS was a 4-item self-administered questionnaire that measures: impairment in work or school, impairment in family and social life, difficulty making plans or commitments, and emotional/affective and cognitive distress. Each item was rated on a 6-point scale as: don't know/ not applicable; never; rarely; some of the time; much of the time; most or all of the time. The MIBS score was the weighted sum of the item scores and ranged from 0 to 12. Higher scores indicated a greater impact of headaches on the participant's life between headache attacks.
Baseline (Day 1) and Week 12
Number of Participants With Any Adverse Events (AEs) by Worst Intensity in the DBT Phase.
Ramy czasowe: DBT Phase: From Day 1 to Week 12
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. AE intensity included mild, moderate and severe, where Mild: usually transient and required only minimal treatment or therapeutic intervention. Event did not generally interfere with usual activities of daily living. Moderate: usually alleviated with additional specific therapeutic intervention. Event interfered with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to participant. Severe: interrupted usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. Participants were counted once in each intensity category based on greatest intensity of unique adverse event preferred terms.
DBT Phase: From Day 1 to Week 12
Number of Participants With Any AEs by Worst Intensity in the OLE Phase
Ramy czasowe: OLE Phase: From Week 12 to Week 24
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. AE intensity included mild, moderate and severe, where Mild: usually transient and required only minimal treatment or therapeutic intervention. Event did not generally interfere with usual activities of daily living. Moderate: usually alleviated with additional specific therapeutic intervention. Event interfered with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to participant. Severe: interrupted usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. Participants were counted once in each intensity category based on greatest intensity of unique adverse event preferred terms.
OLE Phase: From Week 12 to Week 24
Number of Participants With Serious AEs (SAEs) in the DBT Phase
Ramy czasowe: DBT Phase: From Day 1 to Week 12
A serious adverse event (SAE) was any event that met any of the following criteria at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect in the offspring who received rimegepant and other important medical events.
DBT Phase: From Day 1 to Week 12
Number of Participants With SAEs in the OLE Phase
Ramy czasowe: OLE Phase: From Week 12 to Week 24
A SAE was any event that met any of the following criteria at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect in the offspring who received rimegepant and other important medical events.
OLE Phase: From Week 12 to Week 24
Number of Participants With AEs Leading to Study Drug Discontinuation in the DBT Phase
Ramy czasowe: DBT Phase: From Day 1 to Week 12
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. In this outcome measure, participants with AEs leading to discontinuation of study drug were reported.
DBT Phase: From Day 1 to Week 12
Number of Participants With AEs Leading to Study Drug Discontinuation in the OLE Phase
Ramy czasowe: OLE Phase: From Week 12 to Week 24
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. In this outcome measure, participants with AEs leading to discontinuation of study drug were reported.
OLE Phase: From Week 12 to Week 24
Number of Participants With Grade 3 to 4 Laboratory Abnormalities: DBT Phase
Ramy czasowe: DBT Phase: From Day 1 to Week 12
Laboratory tests included hematology and serum chemistry. All laboratory tests except glucose were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0, where Grade 3=severe events which require hospitalization or prolongation of hospitalization and Grade 4=life-threatening consequences requiring urgent intervention. Glucose was graded according to Division of Acquired Immune Deficiency Syndrome table for Grading Severity of Adult and Pediatric Adverse Events v2.1. Only those Grade 3 or 4 laboratory tests with non-zero values in any of treatment arms are reported in this outcome measure.
DBT Phase: From Day 1 to Week 12
Number of Participants With Grade 3 to 4 Laboratory Abnormalities: OLE Phase
Ramy czasowe: OLE Phase: From Week 12 to Week 24
Laboratory tests included hematology and serum chemistry. All laboratory tests except glucose were graded according to NCI CTCAE v5.0, where Grade 3=severe events which require hospitalization or prolongation of hospitalization and Grade 4=life-threatening consequences requiring urgent intervention. Glucose was graded according to Division of Acquired Immune Deficiency Syndrome table for Grading Severity of Adult and Pediatric Adverse Events v2.1. Only those Grade 3 or 4 laboratory tests with non-zero values in any of treatment arms are reported in this outcome measure.
OLE Phase: From Week 12 to Week 24
Percentage of Participants With >= 50% Reduction From OP in the Number of Migraine Days Per Month (Regardless of Pain Intensity) Over the Entire DBT Phase (Weeks 1 to 12)
Ramy czasowe: DBT phase (through Month 3 [Week 1 to 12])
A migraine day was defined as any calendar day in which participant (1) had a qualified migraine headache or (2) took acute migraine-specific medication (i.e., triptan, ergotamine, lasmiditan, or ubrogepant) to treat headache or aura. A qualified migraine headache was defined as a migraine with or without aura, lasting for >=30 minutes, met criteria: >=2 of pain features: unilateral location; pulsating quality (throbbing); moderate or severe pain intensity; aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) or >=1 of associated symptoms: nausea and/or vomiting; photophobia and phonophobia. Number of migraine days per month were prorated to 28 days and derived from data in the on-DBT efficacy analysis period as follows: 28*(total number of migraine days through Month 3 [Weeks 1 to 12])/(total number of e-diary efficacy data days through Month 3 [Weeks 1 to 12]).
DBT phase (through Month 3 [Week 1 to 12])
Mean Number of Acute Migraine-Specific Medication Days Per Month in Each Month and Over the Entire DBT Phase (Weeks 1 to 12)
Ramy czasowe: DBT phase Months 1, 2 and 3; overall DBT through Month 3 (Week 1 to 12)
An acute migraine-specific medication day was defined as any calendar day during which a participant took a migraine-specific acute migraine medication (i.e., triptan, ergotamine, lasmiditan, or ubrogepant) to treat headache or aura. The number of acute migraine-specific medication days per month were prorated to 28 days.
DBT phase Months 1, 2 and 3; overall DBT through Month 3 (Week 1 to 12)
Mean Change From Baseline in MIBS Scores at Weeks 4, 8, and 12 in the DBT Phase
Ramy czasowe: DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
MIBS was a 4-item self-administered questionnaire that measures: impairment in work or school, impairment in family and social life, difficulty making plans or commitments, and emotional/affective and cognitive distress. Each item was rated on a 6-point scale as: don't know/ not applicable; never; rarely; some of the time; much of the time; most or all of the time. The MIBS score was the weighted sum of the item scores and ranged from 0 to 12. Higher scores indicated a greater impact of headaches on the participant's life between headache attacks.
DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
Mean Change From Baseline in MSQ Domain Scores at Weeks 4, 8, and 12 in the DBT Phase
Ramy czasowe: DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
MSQ was a self-administered, 14-item instrument validated in 3 domains: role function-restrictive (7 items), role function-preventive (4 items), emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 to 6, where "1: none of the time," "2: a little bit of the time," "3: some of the time," "4: a good bit of the time," "5: most of the time," and "6: all of the time,". Item scores were recoded using (7 - original score). Raw domain scores are computed as a sum of item responses and rescaled to a 0 to 100 scale such that lower score (0) indicated poor quality of life and higher scores (100) indicated better quality of life.
DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
Mean Change From Baseline in Migraine Functional Impact Questionnaire (MFIQ) Domain Scores in Each Month of the DBT Phase
Ramy czasowe: DBT Phase: Baseline (Day 1), Months 1, 2, and 3
MFIQ was a 26-item participant-report questionnaire. It is designed to measure the subjective impact of migraine on physical, social, and emotional functioning over 5 domains: physical function (5 items), usual activities (10 items), social function (5 items), emotional function (5 items) and overall impact on usual activities (16 items). Participants responded to items using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the past 7 days.
DBT Phase: Baseline (Day 1), Months 1, 2, and 3
Change From Baseline in Work Productivity and Activity Impairment (WPAI) - Migraine Absenteeism Scores at Weeks 4, 8, and 12 in the DBT Phase
Ramy czasowe: DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
The WPAI was a 6-item participant-administered questionnaire used to capture work impairment due to migraine pain. The questions are as follows: Q1 = currently employed (yes/no); Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). The absenteeism score was calculated from Q2 and Q4 for participants who responded "yes" to Q1 and ranged from 0 to 100 with higher score indicating greater impairment and less productivity.
DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
Change From Baseline in WPAI - Migraine Presenteeism Scores at Weeks 4, 8, and 12 in the DBT Phase
Ramy czasowe: DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
The WPAI was a 6-item participant-administered questionnaire used to capture work impairment due to migraine pain. The questions are as follows: Q1 = currently employed (yes/no); Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). The presenteeism score was calculated using Q5 for participants who responded "yes" to Q1 and had Q4>0 and ranged from 0 to 100 with higher score indicating greater impairment and less productivity.
DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
Change From Baseline in WPAI - Migraine Work Productivity Loss Scores at Weeks 4, 8, and 12 in the DBT Phase
Ramy czasowe: DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
The WPAI was a 6-item participant-administered questionnaire used to capture work impairment due to migraine pain. The questions are as follows: Q1 = currently employed (yes/no); Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). The work productivity loss score was calculated using Q2, Q4, and Q5 for participants who responded "yes" to Q1 and ranged from 0 to 100 with higher score indicating greater impairment and less productivity.
DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
Change From Baseline in WPAI - Migraine Activity Impairment Scores at Weeks 4, 8, and 12 in the DBT Phase
Ramy czasowe: DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
The WPAI was a 6-item participant-administered questionnaire used to capture work impairment due to migraine pain. The questions are as follows: Q1 = currently employed (yes/no); Q2 = hours missed due to health problems; Q3 = hours missed due to other reasons; Q4 = hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); Q6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). The activity impairment score was calculated using Q6 and ranged from 0 to 100 with higher score indicating greater impairment and less productivity.
DBT Phase: Baseline (Day 1), Weeks 4, 8, and 12
Mean Change From Baseline in Patient Global Assessment (PGA) Score in Each Month of the DBT Phase
Ramy czasowe: DBT Phase: Baseline (Day 1), Months 1, 2, and 3
The PGA scale was a single item assessment that measured the participant's overall assessment of migraine on a 5-point scale as: (1) very good: asymptomatic and no limitation of normal activities; (2) good: mild symptoms and no limitation of normal activities; (3) fair: moderate symptoms and limitation of some normal activities; (4) poor: severe symptoms and inability to carry out most normal activities; (5) very poor: very severe symptoms which are intolerable and inability to carry out all normal activities. Lower scores indicated fewer symptoms and less disability to carry out normal activities.
DBT Phase: Baseline (Day 1), Months 1, 2, and 3

Współpracownicy i badacze

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Sponsor

Pfizer

Śledczy

  • Dyrektor Studium: Pfizer CT.gov Call Center, Pfizer

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

7 listopada 2022

Zakończenie podstawowe (Rzeczywisty)

31 marca 2025

Ukończenie studiów (Rzeczywisty)

8 lipca 2025

Daty rejestracji na studia

Pierwszy przesłany

23 sierpnia 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

24 sierpnia 2022

Pierwszy wysłany (Rzeczywisty)

26 sierpnia 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 kwietnia 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • BHV3000-407 (CTIS (EU))
  • C4951012 (Inny identyfikator: Alias Study Number)
  • 2024-513270-21-00 (Identyfikator rejestru: CTIS (EU))

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Firma Pfizer zapewni dostęp do danych poszczególnych uczestników, których dane identyfikacyjne zostały pozbawione elementów umożliwiających identyfikację, oraz związanych z nimi dokumentów badawczych (np. protokół, plan analizy statystycznej (SAP), raport z badania klinicznego (CSR)) na żądanie wykwalifikowanych badaczy i z zastrzeżeniem pewnych kryteriów, warunków i wyjątków. Więcej informacji na temat kryteriów udostępniania danych przez firmę Pfizer oraz procesu ubiegania się o dostęp można znaleźć pod adresem: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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