Recruiting
Phase 1

Zavegepant

Sponsor:

Pfizer

Code:

NCT06995729

Conditions

Acute Treatment of Migraine

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Not accepted

Interventions

Zavegepant

Study Details

Brief summary:

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

Study ID

NCT06995729

Start date

May 16, 2025

Status verified date

Mar, 2026

Completion date

Aug 12, 2027

Anticipated

Primary completion date

Aug 12, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

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

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Zavegepant

Experimental medicine under study

Interventions

Zavegepant

Zavegepant 5 mg or 10 mg (dose is weight-dependent)

Primary outcome measure

  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours ]
  • Area Under the Curve From Time Zero to infinity. [ Time Frame: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Coastal Heritage Clinical Research

Recruiting

Hinesville, Georgia, United States, 31313

Children's Hospital & Medical Center

Recruiting

Omaha, Nebraska, United States, 68114

Accellacare - Piedmont

Recruiting

Statesville, North Carolina, United States, 28625

Accellacare of Piedmont HealthCare

Recruiting

Statesville, North Carolina, United States, 28625

Accellacare US Inc.

Recruiting

Winston-Salem, North Carolina, United States, 27103

Central States Research

Recruiting

Tulsa, Oklahoma, United States, 74136

Cedar Health Research

Recruiting

Dallas, Texas, United States, 75251

Wasatch Clinical Research, LLC

Recruiting

Salt Lake City, Utah, United States, 84107

Granger Medical Holladay - Holladay Clinic

Recruiting

Salt Lake City, Utah, United States, 84117

More Information

Sponsor

Pfizer

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • migraine
  • zavegepant
  • pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pfizer on 2026-03-18.