NCT06995729 A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine
| NCT ID | NCT06995729 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Pfizer |
| Condition | Acute Treatment of Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2025-05-16 |
| Primary Completion | 2027-08-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 16 participants in total. It began in 2025-05-16 with a primary completion date of 2027-08-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT06995729 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 11 Years, studying Acute Treatment of Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06995729 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06995729 currently recruiting?
Yes, NCT06995729 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT06995729 trial being conducted?
This trial is being conducted at Little Rock, United States, Washington D.C., United States, Hinesville, United States, Minneapolis, United States and 9 additional locations.
Who is sponsoring the NCT06995729 clinical trial?
NCT06995729 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 16 participants.
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