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Wirksamkeit und Verträglichkeit von Rimegepant zur Vorbeugung von Migräne bei Erwachsenen mit unzureichendem Ansprechen auf orale vorbeugende Medikamente

29. April 2026 aktualisiert von: Pfizer

Phase 4, randomisierte, doppelblinde, placebokontrollierte Studie zur Bewertung der Wirksamkeit und Verträglichkeit von Rimegepant zur Vorbeugung von Migräne bei Erwachsenen mit unzureichendem Ansprechen auf orale vorbeugende Medikamente in der Vorgeschichte

Diese Studie wird durchgeführt, um die Wirksamkeit und Verträglichkeit von Rimegepant zur Migräneprophylaxe bei Erwachsenen mit unzureichendem Ansprechen auf orale vorbeugende Medikamente in der Vorgeschichte zu bewerten

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

962

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • 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
  • Deutschland
      • Berlin, Deutschland, 12672
        • Synexus - Prüfzentrum Berlin
      • Ulm Baden-Wuerttemberg, Deutschland, 89073
        • Neuropoint GmbH
    • Baden-Wurttemberg
      • Göppingen, Baden-Wurttemberg, Deutschland, 73033
        • Schmerz- und Palliativzentrum Göppingen
    • Hesse
      • Bad Homburg, Hesse, Deutschland, 61350
        • Zentrum für klinische Forschung
      • Frankfurt am Main, Hesse, Deutschland, 65929
        • Kopfschmerzzentrum Frankfurt
      • Frankfurt am Main, Hesse, Deutschland, 60313
        • Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre
      • Wiesbaden, Hesse, Deutschland, 65189
        • Intermed GmbH
    • Lower Saxony
      • Westerstede, Lower Saxony, Deutschland, 26655
        • Studienzentrum Nordwest
    • Saxony
      • Leipzig, Saxony, Deutschland, 04103
        • Synexus - Prüfzentrum Leipzig
  • Dänemark
      • Esbjerg, Dänemark, DK-6700
        • University Hospital of Southern Denmark
      • Viborg, Dänemark, DK-8800
        • Hospitalsenhed Midt
    • Capital Region
      • Copenhagen NV, Capital Region, Dänemark, 2400
        • Bispebjerg Hospital
      • Glostrup Municipality, Capital Region, Dänemark, 2600
        • Danish Headache Center
  • Finnland
      • Tampere, Finnland, 33100
        • Terveystalo Tampere
      • Turku, Finnland, 20100
        • Terveystalo Pulssi
    • Uusimaa
      • Helsinki, Uusimaa, Finnland, 00180
        • Terveystalo Ruoholahti
  • 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
  • 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
  • Mexiko
      • Aguascalientes, Mexiko, 20116
        • Centro de Investigación Médica de Aguascalientes (CIMA)
      • Mexico City, Mexiko, CDMX 06700
        • Clinstile, SA de CV
      • Mexico City, Mexiko, CP 14050
        • Operadora Unidad de Investigación En Salud de Chihuahua, Sa de Cv
    • State of Mexico
      • Cuautitlán Izcalli, State of Mexico, Mexiko, 54769
        • Phylasis Clinicas Research S. de R.L. de C.V.
      • Tlalnepantla, State of Mexico, Mexiko, C.P. 54055
        • Clinical Research Institute S.C.
    • Yucatán
      • Mérida, Yucatán, Mexiko, 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
  • Schweden
      • Gothenburg, Schweden, 40545
        • Carlanderska Hospital
      • Lund, Schweden, 222 22
        • Skåneuro Privatmottagning
      • Stockholm, Schweden, 112 39
        • Hälsoklustret
      • Stockholm, Schweden, 117 27
        • Akardo Med Site
      • Uppsala, Schweden, 75185
        • University Hospital Uppsala (VO Neuro)
    • Stockholms LÄN [se-01]
      • Solna, Stockholms LÄN [se-01], Schweden, 171 64
        • CTC Solna
    • Uppsala LÄN [se-03]
      • Uppsala, Uppsala LÄN [se-03], Schweden, 752 37
        • CTC MTC
  • 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
  • Vereinigte Staaten
    • California
      • Los Angeles, California, Vereinigte Staaten, 90048
        • Clinical Research Institute
      • Sherman Oaks, California, Vereinigte Staaten, 91403
        • California Neuroscience Research, LLC
    • Connecticut
      • Stamford, Connecticut, Vereinigte Staaten, 06905
        • Ki Health Partners LLC, dba New England Institute for Clinical Research
    • Florida
      • Edgewater, Florida, Vereinigte Staaten, 32132
        • Sandhill Research, LLC d/b/a Accel Research Sites Network-Edgewater Clinical Research Unit
      • Lake City, Florida, Vereinigte Staaten, 32055
        • Wr-Msra,Llc
      • Miami, Florida, Vereinigte Staaten, 33126
        • AppleMed Research Group, LLC
      • Ocoee, Florida, Vereinigte Staaten, 34761
        • Sensible Healthcare LLC
      • Ormond Beach, Florida, Vereinigte Staaten, 32174
        • Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02131
        • Boston Clinical Trials
      • Marlborough, Massachusetts, Vereinigte Staaten, 01752
        • Community Clinical Research Network, Inc.
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48104
        • Michigan Headache & Neurological Institute
      • Rochester Hills, Michigan, Vereinigte Staaten, 48307
        • Rochester Medical Group
    • Missouri
      • Springfield, Missouri, Vereinigte Staaten, 65807
        • Clinvest Research, LLC
      • Weldon Spring, Missouri, Vereinigte Staaten, 63304
        • St Charles Clinical Research
    • Nevada
      • Las Vegas, Nevada, Vereinigte Staaten, 89118
        • Wr-Crcn, Llc
    • New Mexico
      • Albuquerque, New Mexico, Vereinigte Staaten, 87102
        • Albuquerque Clinical Trials. Inc.
    • New York
      • North Massapequa, New York, Vereinigte Staaten, 11758
        • DiGiovanna Institute for Medical Education and Research
    • North Carolina
      • Greensboro, North Carolina, Vereinigte Staaten, 27405
        • Headache Wellness Center, PC
    • South Carolina
      • Anderson, South Carolina, Vereinigte Staaten, 29621
        • Synexus Clinical Research US, Inc. - Anderson
    • Tennessee
      • Knoxville, Tennessee, Vereinigte Staaten, 37909
        • Alliance for Multispecialty Reseach, LLC
    • Texas
      • Lake Jackson, Texas, Vereinigte Staaten, 77566
        • Red Star Research, LLC
      • Tomball, Texas, Vereinigte Staaten, 77375
        • DM Clinical Research
    • Washington
      • Bellevue, Washington, Vereinigte Staaten, 98007
        • Northwest Clinical Research Center
  • Vereinigtes Königreich
      • Bristol, Vereinigtes Königreich, BS32 4SY
        • Cognition Health - Bristol
      • London, Vereinigtes Königreich, SE5 9PJ
        • Kings college london
      • Swinton, Vereinigtes Königreich, M27 8FF
        • 4 Medical Clinical Solutions
    • Birmingham
      • Edgebaston, Birmingham, Vereinigtes Königreich, B16 8LT
        • Re: Cognition Health Ltd.
    • EAST Riding
      • Hull, EAST Riding, Vereinigtes Königreich, HU3 2JZ
        • Hull University Hospitals NHS Trust
    • Essex
      • Ilford, Essex, Vereinigtes Königreich, IG1 4HP
        • 4 Medical Clinical Solutions London
    • Norfolk
      • Great Yarmouth, Norfolk, Vereinigtes Königreich, NR31 6LA
        • James Paget University Hospitals NHS Foundation Trust
    • Northamptonshire
      • Corby, Northamptonshire, Vereinigtes Königreich, NN17 2UR
        • Lakeside Healthcare Group Research
    • Scotland
      • Glasgow, Scotland, Vereinigtes Königreich, G51 4TF
        • Queen Elizabeth University Hospital
  • Österreich
      • Klagenfurt, Österreich, 9020
        • Klinikum Klagenfurt Am Worthersee
    • Tyrol
      • Innsbruck, Tyrol, Österreich, 6020
        • Medical University Innsbruck

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  1. Migräneanfälle treten länger als 1 Jahr auf, wobei das Alter vor dem 50. Lebensjahr liegt.
  2. Migräneattacken dauern im Durchschnitt etwa 4 - 72 Stunden, wenn sie unbehandelt sind.
  3. 4 bis 14 Migränetage pro Monat im Durchschnitt in den 3 Monaten vor dem Screening-Besuch (Monat ist für die Zwecke dieses Protokolls als 28 Tage definiert).
  4. Weniger als 15 Kopfschmerztage (Migräne oder Nicht-Migräne) pro Monat in jedem der 3 Monate vor dem Screening-Besuch und während der gesamten Screening-Phase.
  5. Die Probanden müssen in der Lage sein, Migräneattacken von Spannungs-/Clusterkopfschmerzen zu unterscheiden. Früheres unzureichendes Ansprechen innerhalb von 10 Jahren nach dem Screening-Besuch auf Wirkstoffe aus 2-4 Kategorien anerkannter, oral verabreichter, Migräne-vorbeugender Medikamente, wobei mindestens ein Beispiel für ein früheres unzureichendes Ansprechen auf mangelnde Wirksamkeit oder vorherige Intoleranz zurückzuführen ist (nicht Kontraindikation).

Ausschlusskriterien:

  1. Vorgeschichte von Cluster-Kopfschmerzen, basilarer Migräne (Migräne mit Hirnstamm-Aura) oder hemiplegischer Migräne.
  2. Aktuelle Kopfschmerzen bei Medikamentenübergebrauch.
  3. 15 oder mehr Kopfschmerztage (Migräne oder Nicht-Migräne) pro Monat in einem der 3 Monate vor dem Screening-Besuch oder während der 28-tägigen Beobachtungsphase.
  4. Unzureichendes Ansprechen (aufgrund mangelnder Wirksamkeit, vorheriger Intoleranz oder Kontraindikation) auf Wirkstoffe in > 4 Kategorien anerkannter, oral verabreichter, vorbeugender Migräne-Medikamente.
  5. Aktives chronisches Schmerzsyndrom (wie Fibromyalgie, chronischer Unterbauchschmerz, komplexes regionales Schmerzsyndrom [CRPS]).
  6. Andere Schmerzsyndrome (einschließlich Trigeminusneuralgie), Demenz oder signifikante neurologische Störungen (außer Migräne), die nach Meinung des Prüfarztes die Studienbewertungen der Sicherheit oder Wirksamkeit beeinträchtigen.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo
Arzneimittel: Placebo
Passendes Placebo mit Dosierung jeden zweiten Tag während der DBT-Phase
Experimental: Rimegepant 75 mg
Arzneimittel: Rimegepant
Rimegepant 75 mg zerfallende Tablette zum Einnehmen (ODT) wird jeden zweiten Tag während der doppelblinden Behandlungsphase (DBT) eingenommen

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
Zeitfenster: 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])

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

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Studienaufzeichnungsdaten

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Haupttermine studieren

Studienbeginn (Tatsächlich)

7. November 2022

Primärer Abschluss (Tatsächlich)

31. März 2025

Studienabschluss (Tatsächlich)

8. Juli 2025

Studienanmeldedaten

Zuerst eingereicht

23. August 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. August 2022

Zuerst gepostet (Tatsächlich)

26. August 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

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Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • BHV3000-407 (CTIS (EU))
  • C4951012 (Andere Kennung: Alias Study Number)
  • 2024-513270-21-00 (Registrierungskennung: CTIS (EU))

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Nein

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