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Effekt og tolerabilitet af Rimegepant til forebyggelse af migræne hos voksne med en historie med utilstrækkelig respons på oral forebyggende medicin

29. april 2026 opdateret af: Pfizer

Fase 4, randomiseret, dobbeltblind, placebokontrolleret undersøgelse for at evaluere effektiviteten og tolerabiliteten af ​​Rimegepant til forebyggelse af migræne hos voksne med en historie med utilstrækkelig respons på oral forebyggende medicin

Denne undersøgelse udføres for at evaluere effektiviteten og tolerabiliteten af ​​rimegepant til migræneprofylakse hos voksne med en historie med utilstrækkelig respons på oral forebyggende medicin

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

962

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

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

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

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Migræneanfald forekommer i mere end 1 år med debutalderen før 50 års alderen.
  2. Migræneanfald varer i gennemsnit omkring 4 - 72 timer, hvis de ikke behandles.
  3. 4 til 14 migrænedage om måneden i gennemsnit i de 3 måneder forud for screeningsbesøget (måned er defineret som 28 dage i forbindelse med denne protokol).
  4. Mindre end 15 hovedpinedage (migræne eller ikke-migræne) om måneden i hver af de 3 måneder forud for screeningsbesøget og i hele screeningsfasen.
  5. Forsøgspersoner skal kunne skelne migræneanfald fra spændings-/klyngehovedpine. Tidligere utilstrækkelig respons, inden for 10 år efter screeningsbesøget, på midler på tværs af 2-4 kategorier af anerkendte, oralt administrerede, migræneforebyggende medicin, hvor mindst ét ​​eksempel på tidligere utilstrækkelig respons skyldes manglende effekt eller tidligere intolerance (ikke kontraindikation).

Ekskluderingskriterier:

  1. Anamnese med klyngehovedpine, basilær migræne (migræne med hjernestammeaura) eller hemiplegisk migræne.
  2. Nuværende medicin overforbrug hovedpine.
  3. 15 eller flere hovedpinedage (migræne eller ikke-migræne) om måneden i en af ​​de 3 måneder forud for screeningsbesøget eller i løbet af den 28-dages observationsfase.
  4. Utilstrækkelig respons (på grund af manglende effekt, tidligere intolerance eller kontraindikation) på midler på tværs af > 4 kategorier af anerkendte, oralt administrerede, migræneforebyggende medicin.
  5. Aktivt kronisk smertesyndrom (såsom fibromyalgi, kronisk bækkensmerter, komplekst regionalt smertesyndrom [CRPS]).
  6. Andre smertesyndromer (herunder trigeminusneuralgi), demens eller væsentlige neurologiske lidelser (bortset fra migræne), der efter investigators mening forstyrrer undersøgelsens vurderinger af sikkerhed eller effekt.

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: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Placebo
Matching af placebo med hver anden dags dosering under DBT-fasen
Eksperimentel: Rimegepant 75 mg
Medicin: Rimegepant
Rimegepant 75 mg Oral Disintegrating Tablet (ODT) taget hver anden dag under dobbeltblind behandling (DBT) fase

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
Tidsramme: 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])

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

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)

7. november 2022

Primær færdiggørelse (Faktiske)

31. marts 2025

Studieafslutning (Faktiske)

8. juli 2025

Datoer for studieregistrering

Først indsendt

23. august 2022

Først indsendt, der opfyldte QC-kriterier

24. august 2022

Først opslået (Faktiske)

26. august 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BHV3000-407 (CTIS (EU))
  • C4951012 (Anden identifikator: Alias Study Number)
  • 2024-513270-21-00 (Registry Identifier: CTIS (EU))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Pfizer vil give adgang til individuelle afidentificerede deltagerdata og relaterede undersøgelsesdokumenter (f.eks. protokol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) efter anmodning fra kvalificerede forskere og underlagt visse kriterier, betingelser og undtagelser. Yderligere detaljer om Pfizers datadelingskriterier og proces for at anmode om adgang kan findes på: 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

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