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

• ClinicalTrials.gov Identifier: NCT05989048
• Recruitment Status: Recruiting
• First Posted: August 14, 2023
• Last Update Posted: May 17, 2024
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: August 3, 2023
• First Posted Date: August 14, 2023
• Last Update Posted Date: May 17, 2024
• Actual Study Start Date: November 29, 2023
• Estimated Primary Completion Date: June 14, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 3, 2023)

• 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.
• 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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Parallel Assignment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

• Condition: Migraine

Intervention

• Drug: Zavegepant
  The participants will receive single active dose sufficient to treat 1 migraine headache of moderate or severe intensity within Treatment Phase.
• Drug: Placebo
  Single dose of matching placebo taken within Treatment Phase.

Study Arms

• Experimental: Zavegepant
  Zavegepant intranasal 10 mg
  Intervention: Drug: Zavegepant
• Placebo Comparator: Placebo
  Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 3, 2023): 1400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 19, 2025
• Estimated Primary Completion Date: June 14, 2025 (Final data collection date for primary outcome measure)

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:

  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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: China, Korea, Republic of, Taiwan

Administrative Information

• NCT Number: NCT05989048
• Other Study ID Numbers: C5301008
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• 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

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

• Current Responsible Party: Pfizer
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: May 2024