Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Efficacia e tollerabilità di Rimegepant per la prevenzione dell'emicrania negli adulti con anamnesi di risposta inadeguata ai farmaci preventivi orali

29 aprile 2026 aggiornato da: Pfizer

Studio di fase 4, randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la tollerabilità di Rimegepant per la prevenzione dell'emicrania negli adulti con una storia di risposta inadeguata ai farmaci preventivi orali

Questo studio è stato condotto per valutare l'efficacia e la tollerabilità di rimegepant per la profilassi dell'emicrania negli adulti con una storia di risposta inadeguata ai farmaci preventivi orali

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

962

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  1. Attacchi di emicrania presenti per più di 1 anno con l'età di insorgenza prima dei 50 anni.
  2. Attacchi di emicrania, in media, della durata di circa 4-72 ore, se non trattati.
  3. Da 4 a 14 giorni di emicrania al mese, in media, nei 3 mesi precedenti la visita di screening (il mese è definito come 28 giorni ai fini del presente protocollo).
  4. Meno di 15 giorni di mal di testa (emicrania o non emicrania) al mese in ciascuno dei 3 mesi precedenti la visita di screening e durante tutta la fase di screening.
  5. I soggetti devono essere in grado di distinguere gli attacchi di emicrania dalla cefalea tensiva/a grappolo. Precedente risposta inadeguata, entro 10 anni dalla visita di screening, ad agenti appartenenti a 2-4 categorie di farmaci riconosciuti, somministrati per via orale, per la prevenzione dell'emicrania in cui almeno un esempio di precedente risposta inadeguata è dovuto a mancanza di efficacia o a precedente intolleranza (non controindicazione).

Criteri di esclusione:

  1. Storia di cefalea a grappolo, emicrania basilare (emicrania con aura del tronco encefalico) o emicrania emiplegica.
  2. Mal di testa da uso eccessivo di farmaci attuali.
  3. 15 o più giorni di mal di testa (emicrania o non emicrania) al mese in uno qualsiasi dei 3 mesi precedenti la visita di screening o durante la fase di osservazione di 28 giorni.
  4. Risposta inadeguata (dovuta a mancanza di efficacia, intolleranza precedente o controindicazione) agli agenti in > 4 categorie di farmaci riconosciuti, somministrati per via orale, per la prevenzione dell'emicrania.
  5. Sindrome da dolore cronico attivo (come fibromialgia, dolore pelvico cronico, sindrome da dolore regionale complesso [CRPS]).
  6. Altre sindromi dolorose (inclusa nevralgia del trigemino), demenza o disturbi neurologici significativi (diversi dall'emicrania) che, secondo l'opinione dello sperimentatore, interferiscono con le valutazioni di sicurezza o efficacia dello studio.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Droga: Placebo
Abbinamento del placebo con la somministrazione a giorni alterni durante la fase DBT
Sperimentale: Rimegepant 75 mg
Droga: Rimegepant
Rimegepant 75 mg compresse disintegranti orali (ODT) assunto a giorni alterni durante la fase di trattamento in doppio cieco (DBT)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
Lasso di tempo: 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])

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Investigatori

  • Direttore dello studio: Pfizer CT.gov Call Center, Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

7 novembre 2022

Completamento primario (Effettivo)

31 marzo 2025

Completamento dello studio (Effettivo)

8 luglio 2025

Date di iscrizione allo studio

Primo inviato

23 agosto 2022

Primo inviato che soddisfa i criteri di controllo qualità

24 agosto 2022

Primo Inserito (Effettivo)

26 agosto 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BHV3000-407 (CTIS (EU))
  • C4951012 (Altro identificatore: Alias Study Number)
  • 2024-513270-21-00 (Identificatore di registro: CTIS (EU))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Pfizer fornirà l'accesso ai dati dei singoli partecipanti anonimi e ai relativi documenti di studio (ad es. protocollo, piano di analisi statistica (SAP), rapporto di studio clinico (CSR)) su richiesta di ricercatori qualificati e soggetti a determinati criteri, condizioni ed eccezioni. Ulteriori dettagli sui criteri di condivisione dei dati di Pfizer e sul processo di richiesta di accesso sono disponibili all'indirizzo: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi