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Účinnost a snášenlivost Rimegepantu pro prevenci migrény u dospělých s historií nedostatečné odpovědi na perorální preventivní léky

29. dubna 2026 aktualizováno: Pfizer

Randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie fáze 4 k vyhodnocení účinnosti a snášenlivosti Rimegepantu pro prevenci migrény u dospělých s historií nedostatečné odpovědi na perorální preventivní léky

Tato studie se provádí za účelem vyhodnocení účinnosti a snášenlivosti rimegepantu pro profylaxi migrény u dospělých s anamnézou nedostatečné odpovědi na perorální preventivní léky.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

962

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Popis

Kritéria pro zařazení:

  1. Záchvaty migrény se vyskytují déle než 1 rok s věkem začátku před 50. rokem věku.
  2. Záchvaty migrény v průměru trvají asi 4 - 72 hodin, pokud se neléčí.
  3. 4 až 14 dní migrény za měsíc v průměru během 3 měsíců před screeningovou návštěvou (měsíc je pro účely tohoto protokolu definován jako 28 dní).
  4. Méně než 15 dní bolesti hlavy (migrenózní nebo nemigrenózní) za měsíc v každém ze 3 měsíců před screeningovou návštěvou a během screeningové fáze.
  5. Subjekty musí být schopny rozlišit záchvaty migrény od tenzní/shlukové bolesti hlavy. Předchozí nepřiměřená odpověď během 10 let od screeningové návštěvy na látky napříč 2–4 kategoriemi uznávaných, perorálně podávaných léků na prevenci migrény, kde alespoň jeden příklad předchozí nedostatečné odpovědi je způsoben nedostatečnou účinností nebo předchozí nesnášenlivostí (ne kontraindikace).

Kritéria vyloučení:

  1. Anamnéza klastrových bolestí hlavy, bazilární migrény (migréna s aurou mozkového kmene) nebo hemiplegická migréna.
  2. Bolesti hlavy z nadužívání současných léků.
  3. 15 nebo více dní bolesti hlavy (migrenózní nebo nemigrenózní) za měsíc v kterémkoli ze 3 měsíců před screeningovou návštěvou nebo během 28denní pozorovací fáze.
  4. Neadekvátní odpověď (kvůli nedostatečné účinnosti, předchozí nesnášenlivosti nebo kontraindikaci) na látky napříč > 4 kategoriemi uznávaných, perorálně podávaných léků na prevenci migrény.
  5. Syndrom aktivní chronické bolesti (jako je fibromyalgie, chronická pánevní bolest, syndrom komplexní regionální bolesti [CRPS]).
  6. Jiné bolestivé syndromy (včetně neuralgie trojklaného nervu), demence nebo významné neurologické poruchy (jiné než migréna), které podle názoru výzkumníka interferují s hodnocením bezpečnosti nebo účinnosti studie.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: Placebo
Lék: Placebo
Přizpůsobení placeba dávkování každý druhý den během fáze DBT
Experimentální: Rimegepant 75 mg
Lék: Rimegepant
Rimegepant 75 mg perorální dezintegrační tableta (ODT) užívaná každý druhý den během fáze dvojitě zaslepené léčby (DBT)

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
Časové okno: 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])

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Pfizer

Vyšetřovatelé

  • Ředitel studie: Pfizer CT.gov Call Center, Pfizer

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

7. listopadu 2022

Primární dokončení (Aktuální)

31. března 2025

Dokončení studie (Aktuální)

8. července 2025

Termíny zápisu do studia

První předloženo

23. srpna 2022

První předloženo, které splnilo kritéria kontroly kvality

24. srpna 2022

První zveřejněno (Aktuální)

26. srpna 2022

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • BHV3000-407 (CTIS (EU))
  • C4951012 (Jiný identifikátor: Alias Study Number)
  • 2024-513270-21-00 (Identifikátor registru: CTIS (EU))

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Společnost Pfizer poskytne přístup k jednotlivým neidentifikovaným údajům účastníků a souvisejícím studijním dokumentům (např. protokol, plán statistické analýzy (SAP), zprávu o klinické studii (CSR)) na žádost kvalifikovaných výzkumných pracovníků a za určitých kritérií, podmínek a výjimek. Další podrobnosti o kritériích sdílení dat společnosti Pfizer a procesu žádosti o přístup naleznete na adrese: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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