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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05989048
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : May 17, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.


Condition or disease Intervention/treatment Phase
Migraine Drug: Zavegepant Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 29, 2023
Estimated Primary Completion Date : June 14, 2025
Estimated Study Completion Date : July 19, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
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.
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Single dose of matching placebo taken within Treatment Phase.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants with pain freedom at 2 hours post dose. [ Time Frame: 2 hours post dose ]
    To compare the efficacy of zavegepant with placebo in the acute treatment of migraine by measuring freedom from pain.

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05989048


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05989048    
Other Study ID Numbers: C5301008
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: May 17, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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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
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases