A Study to Learn About Zavegepant as the Acute Treatment of Migraine in Asian Adults

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Zavegepant Intranasal (IN) for the Acute Treatment of Migraine in Asian Adults

The purpose of this study is to learn how safe and effective zavegepant is compared to placebo in the acute treatment of migraine in Asian adults. Migraine is a very painful headache with other associated symptoms such as nausea, photophobia and phonophobia. A placebo is a harmless treatment that has no medical effect.

This study is seeking for participants who:

• have at least 1 year of migraine history before entering the study.
• have 2 to 8 migraine headache attacks of moderate or severe intensity in each of the 3 months before entering the study.
• have less than 15 days with headaches in each of the 3 months before entering the study. The headaches could be either due to migraine or not.

The participants in this study will receive zavegepant or placebo through intranasal route. Intranasal means medicine which is given through nose. Zavegepant or placebo will be taken if the participants have a migraine headache of moderate or severe intensity.

The study will compare the experiences of people receiving zavegepant to those of the people receiving placebo. This will help see if zavegepant is safe and effective in Asian adults.

Participants will be in this study for up to about 16 weeks. Participants will have 3 study visits at the study clinic and 1 through telephone contact.

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Drug: Zavegepant; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 1400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• China
  • Beijing, China, 100053
    • Recruiting
    • Xuanwu Hospital Capital Medical University
  • Chongqing, China, 404000
    • Not yet recruiting
    • Chongqing University Three Gorges Hospital
  • Shanghai, China, 200120
    • Not yet recruiting
    • Shanghai East Hospital
  • Tianjin, China, 300000
    • Recruiting
    • Tianjin Union Medical Center
  • Anhui
    • Hefei, Anhui, China, 230011
      • Not yet recruiting
      • The Second People's Hospital of Hefei
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • The First Medical Center of Chinese PLA General Hospital
    • Beijing, Beijing, China, 100050
      • Not yet recruiting
      • Beijing Friendship Hospital, Capital Medical University
    • Haidian District, Beijing, China, 100853
      • Not yet recruiting
      • Chinese PLA General Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • Not yet recruiting
      • The First Affiliated Hospital of Chongqing Medical University
  • Hainan
    • Haikou, Hainan, China, 570311
      • Recruiting
      • Hainan General Hospital
  • Hebei
    • Wuhan, Hebei, China, 430060
      • Not yet recruiting
      • Renmin Hospital of Wuhan University
  • Henan
    • Luoyang, Henan, China, 471003
      • Not yet recruiting
      • The First Affiliated Hospital of Henan University of Science &Technology
    • Zhengzhou, Henan, China, 450014
      • Not yet recruiting
      • People's Hospital of Zhengzhou
  • Hubei
    • Wuhan, Hubei, China, 430074
      • Not yet recruiting
      • Wuhan Third Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • The Third Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410004
      • Recruiting
      • Changsha Central Hospital
  • Jiangsu
    • Lianyungang, Jiangsu, China, 222002
      • Not yet recruiting
      • The Second People's Hospital of Lianyungang
    • Lianyungang, Jiangsu, China, 222006
      • Recruiting
      • The Second People's Hospital of Lianyungang
    • Nanjing, Jiangsu, China, 210011
      • Not yet recruiting
      • The Second Affiliated Hospital of Nanjing Medical University
    • Suzhou, Jiangsu, China, 215004
      • Recruiting
      • The Second Affiliated Hospital of Soochow University
    • Wuxi, Jiangsu, China, 214023
      • Recruiting
      • Wuxi People's Hospital
    • Wuxi City,, Jiangsu, China, 214125
      • Recruiting
      • Affiliated Hospital of Jiangnan University
    • Zhenjiang City, Jiangsu, China, 212008
      • Recruiting
      • The Affiliated Hospital of Jiangsu University
  • Jilin
    • Changchun, Jilin, China, 130000
      • Not yet recruiting
      • The First Hospital of Jilin University
    • Changchun, Jilin, China, 130021
      • Not yet recruiting
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110016
      • Recruiting
      • The People's Hospital of Liaoning Province
    • Shenyang, Liaoning, China, 110067
      • Not yet recruiting
      • The People's Hospital of Liaoning Province
  • NING XIA Province
    • Yinchuan, NING XIA Province, China, 750003
      • Recruiting
      • General Hospital of Ningxia Medical Hospital
  • Ningxia Province
    • Yinchuan, Ningxia Province, China, 750001
      • Not yet recruiting
      • The First People's Hospital of Yinchuan
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • The First Affiliated Hospital of Xi'An JiaoTong University
    • Xi'an, Shaanxi, China, 710068
      • Not yet recruiting
      • Shaanxi Provincial People' Hospital
    • Xi'an, Shaanxi, China, 710075
      • Recruiting
      • Xian Gaoxin Hospital
    • Xianyang City,, Shaanxi, China, 716099
      • Recruiting
      • XianYang Hospital OF Yan'an University
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital Of Shandong University
    • Jinan, Shandong, China, 250013
      • Recruiting
      • Jinan Central Hospital
    • Jining City, Shandong, China, 272000
      • Not yet recruiting
      • Affiliated Hospital of Jining Medical University
    • Liaocheng, Shandong, China, 252000
      • Recruiting
      • LiaoCheng People's Hospital
    • Qingdao, Shandong, China, 266042
      • Recruiting
      • Qingdao Central Hospital
    • Rizhao City, Shandong, China, 276800
      • Not yet recruiting
      • People's Hospital of Rizhao
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital, Fudan University
    • Shanghai, Shanghai, China, 200040
      • Not yet recruiting
      • Huashan Hospital, Fudan University
  • Shanxi
    • Changzhi, Shanxi, China, 046000
      • Not yet recruiting
      • Heping Hospital Affiliated to Changzhi Medical College
  • Yunnan Sheng
    • Kunming, Yunnan Sheng, China, 650032
      • Recruiting
      • First Affiliated Hospital of Kunming Medical University
• Korea, Republic of
  • Seoul, Korea, Republic of, 03181
    • Recruiting
    • Kangbuk Samsung Hospital
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Not yet recruiting
      • Seoul National University Bundang Hospital
  • Kyǒnggi-do
    • Goyang-si, Kyǒnggi-do, Korea, Republic of, 10380
      • Recruiting
      • Inje University - Ilsan Paik Hospital
    • Hwaseong-si, Kyǒnggi-do, Korea, Republic of, 18450
      • Recruiting
      • Hallym University Dongtan Sacred Heart Hospital
    • Seongnam, Kyǒnggi-do, Korea, Republic of, 13620
      • Not yet recruiting
      • Seoul National University Bundang Hospital
    • Uijeongbu-si, Kyǒnggi-do, Korea, Republic of, 11765
      • Recruiting
      • Uijeongbu St. Mary's Hospital
  • Pusan-kwangyǒkshi
    • Busan, Pusan-kwangyǒkshi, Korea, Republic of, 49201
      • Recruiting
      • Dong-A University Hospital
  • Seoul-teukbyeolsi [seoul]
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 03080
      • Recruiting
      • Seoul National University Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 03722
      • Recruiting
      • Severance Hospital, Yonsei University Health System
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 05505
      • Not yet recruiting
      • Asan Medical Center
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 01830
      • Recruiting
      • Nowon Eulji Medical Center, Eulji University
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 07804
      • Recruiting
      • Ewha Womans University Seoul Hospital
• Taiwan
  • Taipei, Taiwan, 11217
    • Not yet recruiting
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 114
    • Not yet recruiting
    • Tri-Service General Hospital
  • Taipei City, Taiwan, 11490
    • Recruiting
    • Tri-Service General Hospital
  • Taoyuan, Taiwan, 333
    • Not yet recruiting
    • Chang Gung Medical Foundation-Linkou Branch
  • Taipei
    • Taipei City, Taipei, Taiwan, 114
      • Not yet recruiting
      • Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Asian participants aged 18 years or older at screening.

• Participants with minimum 1 year history of migraine (with or without aura) prior to the Screening Visit, consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:

  1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
  2. Migraine attacks, on average, lasting about 4-72 hours if untreated.
  3. Not more than 8 attacks of moderate or severe pain intensity per month within last 3 months.
  4. Participants must be able to distinguish migraine attacks from tension/cluster headaches.
  5. At least 2 consistent migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and throughout the Screening Phase (participant self-report).
  6. Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase (participant self-report).
  7. Participants on prophylactic migraine medication are permitted to remain on therapy if they have been on a stable dose for at least 3 months prior to Screening Visit, and if the dose is not expected to change through the End of Treatment Visit.
  8. Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Exclusion Criteria:

• History of retinal migraine, basilar migraine or hemiplegic migraine.
• History or current evidence of uncontrolled, unstable or recently diagnosed cardiovascular or cardiometabolic disease.
• Major depressive disorder, anxiety disorder, or other significant psychiatric disorder.
• Acute or chronic pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that interfere with study assessments.
• Conditions that may affect the administration or absorption of the nasal product.
• Medication overuse headaches.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Single dose of matching placebo taken within Treatment Phase.
Experimental: Zavegepant; Zavegepant intranasal 10 mg	Drug: Zavegepant; The participants will receive single active dose sufficient to treat 1 migraine headache of moderate or severe intensity within Treatment Phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with pain freedom at 2 hours post dose.	To compare the efficacy of zavegepant with placebo in the acute treatment of migraine by measuring freedom from pain.	2 hours post dose
Percentage of participants with an MBS (most bothersome symptom) reported before dosing that is absent at 2 hours post dose.	To compare the efficacy of zavegepant with placebo in the acute treatment of migraine by measuring freedom from MBS.	2 hours post dose

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Estimated): July 3, 2025
• Study Completion (Estimated): September 20, 2025

Study Registration Dates

• First Submitted: August 3, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: C5301008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes