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

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Zavegepant

Placebo

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age. Migraine attacks, on average, lasting about 4-72 hours if untreated. Not more than 8 attacks of moderate or severe pain intensity per month within last 3 months. Participants must be able to distinguish migraine attacks from tension/cluster headaches. 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). 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). 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. 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.

Sites / Locations

Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zavegepant

Placebo

Arm Description

Zavegepant intranasal 10 mg

Placebo

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05989048

First Posted

August 3, 2023

Last Updated

September 15, 2023

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT05989048

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 10, 2023 (Anticipated)

Primary Completion Date

August 1, 2025 (Anticipated)

Study Completion Date

September 5, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

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

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Zavegepant

Arm Type

Experimental

Arm Description

Zavegepant intranasal 10 mg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Zavegepant

Intervention Description

The participants will receive single active dose sufficient to treat 1 migraine headache of moderate or severe intensity within Treatment Phase.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Single dose of matching placebo taken within Treatment Phase.

Primary Outcome Measure Information:

Title

Percentage of participants with pain freedom at 2 hours post dose.

Description

To compare the efficacy of zavegepant with placebo in the acute treatment of migraine by measuring freedom from pain.

Time Frame

2 hours post dose

Title

Percentage of participants with an MBS (most bothersome symptom) reported before dosing that is absent at 2 hours post dose.

Description

To compare the efficacy of zavegepant with placebo in the acute treatment of migraine by measuring freedom from MBS.

Time Frame

2 hours post dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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: Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age. Migraine attacks, on average, lasting about 4-72 hours if untreated. Not more than 8 attacks of moderate or severe pain intensity per month within last 3 months. Participants must be able to distinguish migraine attacks from tension/cluster headaches. 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). 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). 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pfizer CT.gov Call Center

Phone

1-800-718-1021

Email

ClinicalTrials.gov_Inquiries@pfizer.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Chinese PLA General Hospital

City

Haidian District

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=C5301008

Description

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Migraine

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial