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En undersøgelse for at lære om Zavegepant som den akutte behandling af migræne hos asiatiske voksne

29. april 2026 opdateret af: Pfizer

Et fase 3, randomiseret, dobbeltblindt, placebokontrolleret, parallelt gruppestudie for at evaluere effektiviteten og sikkerheden af ​​Zavegepant Intranasal (IN) til akut behandling af migræne hos asiatiske voksne

Formålet med denne undersøgelse er at lære, hvor sikker og effektiv zavegepant er sammenlignet med placebo ved akut behandling af migræne hos asiatiske voksne. Migræne er en meget smertefuld hovedpine med andre associerede symptomer såsom kvalme, fotofobi og fonofobi. En placebo er en harmløs behandling, der ikke har nogen medicinsk effekt.

Denne undersøgelse søger deltagere, der:

  • har mindst 1 års migrænehistorie, før du går ind i studiet.
  • har 2 til 8 migrænehovedpineanfald af moderat eller svær intensitet i hver af de 3 måneder, før de går ind i undersøgelsen.
  • har mindre end 15 dage med hovedpine i hver af de 3 måneder, før de går ind i undersøgelsen. Hovedpinen kan enten skyldes migræne eller ej.

Deltagerne i denne undersøgelse vil modtage zavegepant eller placebo gennem intranasal vej. Intranasal betyder medicin, der gives gennem næsen. Zavegepant eller placebo vil blive taget, hvis deltagerne har en migrænehovedpine af moderat eller svær intensitet.

Undersøgelsen vil sammenligne erfaringerne fra personer, der får zavegepant, med de personer, der får placebo. Dette vil hjælpe med at se, om zavegepant er sikkert og effektivt hos asiatiske voksne.

Deltagerne vil være i denne undersøgelse i op til omkring 16 uger. Deltagerne vil have 3 studiebesøg på studieklinikken og 1 gennem telefonisk kontakt.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1414

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Kina
      • Beijing, Kina, 100044
        • Peking University People's Hospital
      • Beijing, Kina, 100053
        • Xuanwu Hospital Capital Medical University
      • Chongqing, Kina, 404000
        • Chongqing University Three Gorges Hospital
      • Chongqing, Kina
        • The fourth people's hospital of chongqing
      • Shanghai, Kina, 200120
        • Shanghai East Hospital
      • Tianjin, Kina, 300000
        • Tianjin Union Medical Center
    • Anhui
      • Hefei, Anhui, Kina, 230011
        • The Second People's Hospital of Hefei
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100050
        • Beijing Friendship Hospital, Capital Medical University
      • Beijing, Beijing Municipality, Kina, 100853
        • The First Medical Center of Chinese PLA General Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 400016
        • The First Affiliated Hospital of Chongqing Medical University
    • Hainan
      • Haikou, Hainan, Kina, 570311
        • Hainan General Hospital
    • Hebei
      • Wuhan, Hebei, Kina, 430060
        • Renmin Hospital of Wuhan University
    • Henan
      • Luoyang, Henan, Kina, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Luoyang, Henan, Kina, 471000
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Zhengzhou, Henan, Kina, 450000
        • People's Hospital of Zhengzhou
    • Hubei
      • Wuhan, Hubei, Kina, 430074
        • Wuhan Third Hospital
    • Hunan
      • Changsha, Hunan, Kina, 410013
        • The Third Xiangya Hospital of Central South University
      • Changsha, Hunan, Kina, 410004
        • Changsha Central Hospital
    • Jiangsu
      • Lianyungang, Jiangsu, Kina, 222006
        • The Second People's Hospital of Lianyungang
      • Nanjing, Jiangsu, Kina, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
      • Suzhou, Jiangsu, Kina, 215004
        • The Second Affiliated Hospital of Soochow University
      • Wuxi, Jiangsu, Kina, 214023
        • Wuxi People's Hospital
      • Wuxi, Jiangsu, Kina, 214125
        • Affiliated Hospital of Jiangnan University
      • Zhenjiang, Jiangsu, Kina, 212008
        • The Affiliated Hospital of Jiangsu University
    • Jiangxi
      • Pingxiang, Jiangxi, Kina, 337055
        • Pingxiang People's Hospital
    • Jilin
      • Changchun, Jilin, Kina, 130000
        • The First Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, Kina, 110016
        • The People's Hospital of Liaoning Province
    • Ningxia
      • Yinchuan, Ningxia, Kina, 750001
        • The First People's Hospital of Yinchuan
      • Yinchuan, Ningxia, Kina, 750003
        • General Hospital of Ningxia Medical Hospital
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Shaanxi, Kina, 710068
        • Shaanxi Provincial People' Hospital
      • Xi'an, Shaanxi, Kina, 710075
        • Xian Gaoxin Hospital
      • Xianyang, Shaanxi, Kina, 716099
        • Xianyang Hospital of Yan'an University
    • Shandong
      • Jinan, Shandong, Kina, 250012
        • QiLU Hospital of ShanDong University
      • Jinan, Shandong, Kina, 250013
        • Jinan Central Hospital
      • Jining, Shandong, Kina, 272000
        • Affiliated Hospital of Jining Medical University
      • Liaocheng, Shandong, Kina, 252000
        • Liaocheng people's Hospital
      • Qingdao, Shandong, Kina, 266042
        • Qingdao Central Hospital
      • Rizhao, Shandong, Kina, 276800
        • People's Hospital of Rizhao
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200040
        • Huashan Hospital, Fudan University
      • Shanghai, Shanghai Municipality, Kina, 200123
        • Shanghai East Hospital
    • Shanxi
      • Changzhi, Shanxi, Kina, 046000
        • Heping Hospital affiliated to Changzhi Medical College
    • Yunnan
      • Kunming, Yunnan, Kina, 650032
        • First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310016
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
      • Rui’an, Zhejiang, Kina, 325200
        • Ruian People's Hospital
      • Wenzhou, Zhejiang, Kina, 325000
        • The First Affiliated Hosptial of Wenzhou Medical University
  • Sydkorea
      • Seoul, Sydkorea, 03181
        • Kangbuk Samsung Hospital
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Sydkorea, 13620
        • Seoul National University Bundang Hospital
    • Kyǒnggi-do
      • Goyang-si, Kyǒnggi-do, Sydkorea, 10380
        • Inje University - Ilsan Paik Hospital
      • Hwaseong-si, Kyǒnggi-do, Sydkorea, 18450
        • Hallym University Dongtan Sacred Heart Hospital
      • Seongnam, Kyǒnggi-do, Sydkorea, 13620
        • Seoul National University Bundang Hospital
      • Uijeongbu-si, Kyǒnggi-do, Sydkorea, 11765
        • The Catholic University of Korea, Uijeongbu St. Mary's Hospital
    • Pusan-kwangyǒkshi
      • Busan, Pusan-kwangyǒkshi, Sydkorea, 49201
        • Dong-A University Hospital
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], Sydkorea, 03080
        • Seoul National University Hospital
      • Seoul, Seoul-teukbyeolsi [seoul], Sydkorea, 05505
        • Asan Medical Center
      • Seoul, Seoul-teukbyeolsi [seoul], Sydkorea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul-teukbyeolsi [seoul], Sydkorea, 01830
        • Nowon Eulji Medical Center, Eulji University
      • Seoul, Seoul-teukbyeolsi [seoul], Sydkorea, 07804
        • Ewha Womans University Seoul Hospital
  • Taiwan
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 11490
        • Tri-Service General Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Asiatiske deltagere på 18 år eller ældre ved screening.

  • Deltagere med minimum 1 års historie med migræne (med eller uden aura) før screeningsbesøget, i overensstemmelse med en diagnose i henhold til International Classification of Headache Disorders, 3. udgave, inklusive følgende:

    1. Migræneanfald forekommer i mere end 1 år med alderen før 50 års alderen.
    2. Migræneanfald varer i gennemsnit omkring 4-72 timer, hvis de ikke behandles.
    3. Ikke mere end 8 anfald af moderat eller svær smerteintensitet om måneden inden for de sidste 3 måneder.
    4. Deltagerne skal kunne skelne migræneanfald fra spændings-/klyngehovedpine.
    5. Mindst 2 konsekvente migrænehovedpineanfald af moderat eller svær intensitet i hver af de 3 måneder forud for screeningsbesøget og gennem hele screeningsfasen (deltagers selvrapportering).
    6. Mindre end 15 dage med hovedpine (migræne eller ikke-migræne) om måneden i hver af de 3 måneder forud for screeningsbesøget og i hele screeningsfasen (deltagers selvrapportering).
    7. Deltagere på profylaktisk migrænemedicin har tilladelse til at forblive i behandling, hvis de har været på en stabil dosis i mindst 3 måneder forud for screeningsbesøget, og hvis dosis ikke forventes at ændre sig gennem afslutningen af ​​behandlingsbesøget.
    8. Deltagere med kontraindikationer for brug af triptaner kan inkluderes, forudsat at de opfylder alle andre kriterier for studieoptagelse.

Ekskluderingskriterier:

  • Anamnese med retinal migræne, basilær migræne eller hemiplegisk migræne.
  • Anamnese eller aktuelle tegn på ukontrolleret, ustabil eller nyligt diagnosticeret kardiovaskulær eller kardiometabolisk sygdom.
  • Større depressiv lidelse, angstlidelse eller anden betydelig psykiatrisk lidelse.
  • Akutte eller kroniske smertesyndromer, psykiatriske tilstande, demens eller betydelige neurologiske lidelser (bortset fra migræne), der forstyrrer undersøgelsesvurderinger.
  • Tilstande, der kan påvirke administrationen eller absorptionen af ​​det nasale produkt.
  • Overforbrug af medicin hovedpine.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Placebo
Enkelt dosis af matchende placebo taget inden for behandlingsfasen.
Eksperimentel: Zavegepant
Zavegepant intranasal 10 mg
Medicin: Zavegepant
Deltagerne vil modtage en enkelt aktiv dosis, der er tilstrækkelig til at behandle 1 migrænehovedpine af moderat eller svær intensitet i behandlingsfasen.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Pain Freedom at 2 Hours Post-dose
Tidsramme: At 2 hours post-dose
Pain freedom was defined as pain intensity being none at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
At 2 hours post-dose
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
Tidsramme: At 2 hours post-dose
MBS was selected from nausea, phonophobia or photophobia before dosing by the participants. In this outcome measure, percentage of participants who recorded an MBS (present) before dosing and did not have the MBS (absent) at the time of evaluation (i.e., 2 hours post-dose) were reported.
At 2 hours post-dose

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Pain Relief at 15 Minutes Post-dose
Tidsramme: At 15 minutes post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
At 15 minutes post-dose
Percentage of Participants With Pain Relief at 30 Minutes Post-dose
Tidsramme: At 30 minutes post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
At 30 minutes post-dose
Percentage of Participants With Pain Relief at 2 Hours Post-dose
Tidsramme: At 2 hours post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
At 2 hours post-dose
Percentage of Participants Who Returned to Normal Function at 2 Hours Post-dose
Tidsramme: At 2 hours post-dose
Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 2 hours post-dose) were reported.
At 2 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose
Tidsramme: From 2 hours post-dose to 24 hours post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). This outcome of sustained pain relief was defined as pain intensity being mild or none at all time points from 2 to 24 hours post-dose with missing data <=1 time point from 3 to 8 hours post-dose.
From 2 hours post-dose to 24 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose
Tidsramme: From 2 hours post-dose to 48 hours post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). This outcome of sustained pain relief was defined as pain intensity being mild or none at all time points from 2 to 48 hours post-dose with missing data <=1 time point from 3 to 8 hours post-dose.
From 2 hours post-dose to 48 hours post-dose
Percentage of Participants Who Returned to Normal Function at 30 Minutes Post-dose
Tidsramme: At 30 minutes post-dose
Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 30 minutes post-dose) were reported.
At 30 minutes post-dose
Percentage of Participants Who Returned to Normal Function at 60 Minutes Post-dose
Tidsramme: At 60 minutes post-dose
Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 60 minutes post-dose) were reported.
At 60 minutes post-dose
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose
Tidsramme: At 2 hours post-dose
Freedom from phonophobia was defined as phonophobia absent at specified time point for participants with the phonophobia present at the time of dosing. In this outcome measure, percentage of participants who had phonophobia at the time of dosing and then recorded phonophobia absent at the time of evaluation (i.e., 2 hours post-dose) were reported.
At 2 hours post-dose
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose
Tidsramme: At 2 hours post-dose
Freedom from photophobia was defined as photophobia absent at specified time point for participants with the photophobia present at the time of dosing. In this outcome measure, percentage of participants who had photophobia at the time of dosing and then recorded photophobia absent at the time of evaluation (i.e., 2 hours post-dose) were reported.
At 2 hours post-dose
Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose
Tidsramme: At 2 hours post-dose
Freedom from nausea was defined as nausea absent at specified time point for participants with the nausea present at the time of dosing. In this outcome measure, percentage of participants who had nausea at the time of dosing and then recorded nausea absent at time of evaluation (i.e., 2 hours post-dose) were reported.
At 2 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose
Tidsramme: From 2 hours post-dose to 24 hours post-dose
Pain freedom was defined as pain intensity being none at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). Sustained pain freedom was defined as pain intensity being none at all time points from 2 to 24 hours post-dose with missing data <=1 time point from 3 to 8 hours post-dose.
From 2 hours post-dose to 24 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose
Tidsramme: From 2 hours post-dose to 48 hours post-dose
Pain freedom was defined as pain intensity being none at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). Sustained pain freedom was defined as pain intensity being none at all time points from 2 to 48 hours post-dose with missing data <=1 time point from 3 to 8 hours post-dose.
From 2 hours post-dose to 48 hours post-dose
Percentage of Participants With Pain Relapse at Any Time Point After 2 Hours Post-dose to 48 Hours Post-dose
Tidsramme: From after 2 hours post-dose to 48 hours post-dose
Pain relapse was defined as pain intensity of mild, moderate, or severe at any time point after 2 hours to 48 hours post-dose for participants with pain intensity of none at 2 hours post-dose. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
From after 2 hours post-dose to 48 hours post-dose
Percentage of Participants Taking Rescue Medication Within 24 Hours Post-dose
Tidsramme: Within 24 hours post-dose
Participants who did not experience relief (pain intensity of none or mild) of their migraine headache at the end of 2 hours post-dose, or the migraine was relieved at 2 hours post-dose, but then recurred to a moderate or severe pain intensity level, were permitted to use the following rescue medications: aspirin, ibuprofen, naproxen (or any other type of nonsteroidal anti-inflammatory drug), acetaminophen up to 1000 mg/day (this included Excedrin Migraine), antiemetics (for example, metoclopramide or promethazine), or baclofen.
Within 24 hours post-dose
Percentage of Participants With Pain Relief at 60 Minutes Post-dose
Tidsramme: At 60 minutes post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
At 60 minutes post-dose
Percentage of Participants Who Returned to Normal Function at 15 Minutes Post-dose
Tidsramme: At 15 minutes post-dose
Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 15 minutes post-dose) were reported.
At 15 minutes post-dose
Number of Participants With Adverse Events (AEs) of Moderate or Severe Intensity: On-Treatment Period
Tidsramme: On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Moderate AE: A type of AE that was usually alleviated with additional specific therapeutic intervention. The event interfered with usual activity/activities of daily living (ADL), causing discomfort, but posed no significant or permanent risk of harm to the research participant. Severe AE: A type of AE that interrupted usual ADL, or significantly affected clinical status, or might have required intensive therapeutic intervention.
On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Number of Participants With AEs of Moderate or Severe Intensity: Follow-up Period
Tidsramme: Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Moderate AE: A type of AE that was usually alleviated with additional specific therapeutic intervention. The event interfered with usual ADL, causing discomfort, but posed no significant or permanent risk of harm to the research participant. Severe AE: A type of AE that interrupted usual ADL, or significantly affected clinical status, or might have required intensive therapeutic intervention.
Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
Number of Participants With Serious Adverse Events (SAEs): On-Treatment Period
Tidsramme: On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic, or other situations.
On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Number of Participants With SAEs: Follow-up Period
Tidsramme: Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic, or other situations.
Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
Number of Participants With Local Irritation AEs: On-Treatment Period
Tidsramme: On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Local irritation AEs were associated with intranasal administration of study intervention (e.g., dysgeusia, nasal discomfort, oropharyngeal pain, throat irritation, and laryngeal discomfort).
On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Number of Participants With Local Irritation AEs: Follow-up Period
Tidsramme: Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Local irritation AEs were associated with intranasal administration of study intervention (e.g., dysgeusia, nasal discomfort, oropharyngeal pain, throat irritation, and laryngeal discomfort).
Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
Number of Participants With Grade 3 to 4 Hematological Test Abnormalities: On-Treatment Period
Tidsramme: On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Hematological test abnormalities included: anemia, eosinophilia, hemoglobin increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophils count decreased, platelet count decreased and white blood cell decreased. Only those hematology test categories in which at least one participant in at least one reporting arm experienced a Grade 3 or Grade 4 abnormality were reported in this outcome measure. The hematological test abnormalities grade 3 to 4 were graded according to the common terminology criteria for adverse events (CTCAE) version (v) 5.0.
On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Number of Participants With Grade 3 to 4 Clinical Chemistry Test Abnormalities: On-Treatment Period
Tidsramme: On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Clinical chemistry test abnormalities included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, blood lactate dehydrogenase increased, creatine phosphokinase (CPK) increased, chronic kidney disease, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia and hyponatremia. Only those clinical chemistry test categories in which at least one participant in at least one reporting arm experienced a Grade 3 or Grade 4 abnormality were reported in this outcome measure. The clinical chemistry test abnormalities grade 3 to 4 were graded according to the CTCAE v 5.0.
On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Efterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. november 2023

Primær færdiggørelse (Faktiske)

30. maj 2025

Studieafslutning (Faktiske)

30. maj 2025

Datoer for studieregistrering

Først indsendt

3. august 2023

Først indsendt, der opfyldte QC-kriterier

3. august 2023

Først opslået (Faktiske)

14. august 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C5301008
  • NCT05989048 (Registry Identifier: ClinicalTrials.gov)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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