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A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine

Description

The purpose of the study is to learn about safety and how the body processes the study medicine called Zavegepant (PF-07930207) in children with a history of migraine. This study helps understand how the medicine is changed and removed from the body after taking it. This study is seeking participants who: * Are children aged between 6 and less than 12 years old * Have had migraine for at least 6 months. * Weigh more than 15 kilograms All participants in this study will receive zavegepant as a nasal spray once (one spray into one nostril). The dose of the study medicine that each participant receives will depend on how much the participant weighs. The study will look at the experiences of the participants receiving the study medicine and collect data to better understand the possible benefits and unwanted effects of different doses of the study medicine. Participants will take part in this study for up to 10 weeks. During this time, they will have 3 study visits at the study clinic, and 2 follow-up phone calls.

Conditions

Acute Treatment of Migraine
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Related Conditions:

Acute Treatment of Migraine

Study Overview

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Study Details

Study overview

The purpose of the study is to learn about safety and how the body processes the study medicine called Zavegepant (PF-07930207) in children with a history of migraine. This study helps understand how the medicine is changed and removed from the body after taking it. This study is seeking participants who: * Are children aged between 6 and less than 12 years old * Have had migraine for at least 6 months. * Weigh more than 15 kilograms All participants in this study will receive zavegepant as a nasal spray once (one spray into one nostril). The dose of the study medicine that each participant receives will depend on how much the participant weighs. The study will look at the experiences of the participants receiving the study medicine and collect data to better understand the possible benefits and unwanted effects of different doses of the study medicine. Participants will take part in this study for up to 10 weeks. During this time, they will have 3 study visits at the study clinic, and 2 follow-up phone calls.

A PHASE 1, MULTICENTER, OPEN-LABEL, SINGLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF ZAVEGEPANT IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH HISTORY OF MIGRAINE

A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine

Condition
Acute Treatment of Migraine
Intervention / Treatment

-

Contacts and Locations

Washington

Velocity Clinical Research, Washington DC, Washington, District of Columbia, United States, 20016

Hinesville

Coastal Heritage Clinical Research, Hinesville, Georgia, United States, 31313

Tulsa

Central States Research, Tulsa, Oklahoma, United States, 74136

Salt Lake City

Wasatch Clinical Research, LLC, Salt Lake City, Utah, United States, 84107

Salt Lake City

Granger Medical Holladay - Holladay Clinic, Salt Lake City, Utah, United States, 84117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Participants aged 6 years to less than 12 years.
  • 2. Documented medical history of migraine with or without aura for at least 6 months before the Screening Visit.
  • 3. Weight \>15 kg at the Screening Visit
  • 1. Evidence or history of clinically significant disease.
  • 2. Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
  • 3. Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome.
  • 4. Conditions that may affect the administration or absorption of the nasal product
  • 5. Any psychiatric condition that is uncontrolled and/or untreated, including:
  • * Clinically significant depression (Promis Parent Proxy SF 2.0 Depressive Scale T score ≥70)
  • * Suicidal ideation and behaviour (C-SSRS: any "yes" to items 2 to 5 or any "yes" to suicide behaviours)
  • 6. Serum Total bilirubin \>1.5 × ULN (Upper Limit of Normal), AST (Aspartate Transferase) or ALT (Alanine Transaminase) \>2 × ULN
  • 7. Abnormal ECG (Electrocardiogram) at screening visit

Ages Eligible for Study

6 Years to 11 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2027-08-12