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Uno studio per conoscere Zavegepant come trattamento acuto dell'emicrania negli adulti asiatici

29 aprile 2026 aggiornato da: Pfizer

Uno studio di fase 3, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per valutare l'efficacia e la sicurezza di Zavegepant intranasale (IN) per il trattamento acuto dell'emicrania negli adulti asiatici

Lo scopo di questo studio è scoprire quanto zavegepant sia sicuro ed efficace rispetto al placebo nel trattamento acuto dell'emicrania negli adulti asiatici. L'emicrania è un mal di testa molto doloroso con altri sintomi associati come nausea, fotofobia e fonofobia. Un placebo è un trattamento innocuo che non ha alcun effetto medico.

Questo studio è alla ricerca di partecipanti che:

  • avere almeno 1 anno di storia di emicrania prima di entrare nello studio.
  • avere da 2 a 8 attacchi di emicrania di intensità moderata o grave in ciascuno dei 3 mesi prima di entrare nello studio.
  • avere meno di 15 giorni con mal di testa in ciascuno dei 3 mesi prima di entrare nello studio. Il mal di testa potrebbe essere dovuto o meno all'emicrania.

I partecipanti a questo studio riceveranno zavegepant o placebo per via intranasale. Intranasale significa medicina che viene somministrata attraverso il naso. Verrà assunto Zavegepant o placebo se i partecipanti hanno un'emicrania di intensità moderata o grave.

Lo studio confronterà le esperienze delle persone che ricevono zavegepant con quelle delle persone che ricevono il placebo. Questo aiuterà a vedere se zavegepant è sicuro ed efficace negli adulti asiatici.

I partecipanti parteciperanno a questo studio per un massimo di circa 16 settimane. I partecipanti avranno 3 visite di studio presso la clinica dello studio e 1 tramite contatto telefonico.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1414

Fase

  • Fase 3

Contatti e Sedi

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

Luoghi di studio

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

Criteri di partecipazione

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

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Partecipanti asiatici di età pari o superiore a 18 anni allo screening.

  • - Partecipanti con almeno 1 anno di storia di emicrania (con o senza aura) prima della visita di screening, coerente con una diagnosi secondo la classificazione internazionale dei disturbi della cefalea, 3a edizione, inclusi i seguenti:

    1. Attacchi di emicrania presenti per più di 1 anno con l'età di insorgenza prima dei 50 anni.
    2. Gli attacchi di emicrania, in media, durano circa 4-72 ore se non trattati.
    3. Non più di 8 attacchi di intensità di dolore moderata o grave al mese negli ultimi 3 mesi.
    4. I partecipanti devono essere in grado di distinguere gli attacchi di emicrania dalla tensione/mal di testa a grappolo.
    5. Almeno 2 attacchi di emicrania consistenti di intensità moderata o grave in ciascuno dei 3 mesi precedenti la visita di screening e durante tutta la fase di screening (autovalutazione del partecipante).
    6. Meno di 15 giorni con mal di testa (emicrania o non emicrania) al mese in ciascuno dei 3 mesi precedenti la visita di screening e durante tutta la fase di screening (autovalutazione del partecipante).
    7. I partecipanti che assumono farmaci profilattici per l'emicrania possono continuare la terapia se hanno assunto una dose stabile per almeno 3 mesi prima della visita di screening e se non si prevede che la dose cambi durante la visita di fine trattamento.
    8. I partecipanti con controindicazioni all'uso di triptani possono essere inclusi a condizione che soddisfino tutti gli altri criteri di ammissione allo studio.

Criteri di esclusione:

  • Storia di emicrania retinica, emicrania basilare o emicrania emiplegica.
  • Anamnesi o evidenza attuale di malattia cardiovascolare o cardiometabolica incontrollata, instabile o di recente diagnosi.
  • Disturbo depressivo maggiore, disturbo d'ansia o altro disturbo psichiatrico significativo.
  • Sindromi dolorose acute o croniche, condizioni psichiatriche, demenza o disturbi neurologici significativi (diversi dall'emicrania) che interferiscono con le valutazioni dello studio.
  • Condizioni che possono influenzare la somministrazione o l'assorbimento del prodotto nasale.
  • Mal di testa da uso eccessivo di farmaci.

Piano di studio

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

Come è strutturato lo studio?

Dettagli di progettazione

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

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Droga: Placebo
Singola dose di placebo corrispondente assunta durante la fase di trattamento.
Sperimentale: Zavegepant
Zavegepant intranasale 10 mg
Droga: Zavegepant
I partecipanti riceveranno una singola dose attiva sufficiente per trattare 1 emicrania di intensità moderata o grave all'interno della fase di trattamento.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Pain Freedom at 2 Hours Post-dose
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Pain Relief at 15 Minutes Post-dose
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

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

Sponsor

Pfizer

Investigatori

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

Pubblicazioni e link utili

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

Collegamenti utili

Studiare le date dei record

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

Studia le date principali

Inizio studio (Effettivo)

29 novembre 2023

Completamento primario (Effettivo)

30 maggio 2025

Completamento dello studio (Effettivo)

30 maggio 2025

Date di iscrizione allo studio

Primo inviato

3 agosto 2023

Primo inviato che soddisfa i criteri di controllo qualità

3 agosto 2023

Primo Inserito (Effettivo)

14 agosto 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • C5301008
  • NCT05989048 (Identificatore di registro: ClinicalTrials.gov)

Piano per i dati dei singoli partecipanti (IPD)

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

SÌ

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

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

Prove cliniche su Zavegepant

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Belgium

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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