Acute Treatment of MigrainePhase 1NCT06995729
A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine
A Phase 1 study testing Zavegepant in people with Acute Treatment of Migraine, run by Pfizer at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Acute Treatment of Migraine
- What is being tested?
- Zavegepant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 14 sitesUnited States
- Study dates
- 16 May 2025to 12 Aug 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants aged 6 years to less than 12 years.
- Documented medical history of migraine with or without aura for at least 6 months before the Screening Visit.
- Weight >15 kg at the Screening Visit
Who cannot join
- Evidence or history of clinically significant disease.
- Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
- Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome.
- Conditions that may affect the administration or absorption of the nasal product
- Any psychiatric condition that is uncontrolled and/or untreated, including:
- Clinically significant depression (Promis Parent Proxy SF 2.0 Depressive Scale T score ≥70)
Show all 9Show fewer
- Suicidal ideation and behaviour (C-SSRS: any "yes" to items 2 to 5 or any "yes" to suicide behaviours)
- Serum Total bilirubin >1.5 × ULN (Upper Limit of Normal), AST (Aspartate Transferase) or ALT (Alanine Transaminase) >2 × ULN
- Abnormal ECG (Electrocardiogram) at screening visit
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 11 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
- Active, not recruiting
Cedar Health Research
Dallas, Texas, 75251
- Recruiting
Coastal Heritage Clinical Research
Hinesville, Georgia, 31313
- Recruiting
Clinical Research Institute
Minneapolis, Minnesota, 55402
- Recruiting
Children's Hospital & Medical Center
Omaha, Nebraska, 68114
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
- Recruiting
True North Neurology
Port Jefferson Station, New York, 11776
- Active, not recruiting
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107
- Active, not recruiting
Granger Medical Holladay - Holladay Clinic
Salt Lake City, Utah, 84117
- Recruiting
Accellacare - Piedmont
Statesville, North Carolina, 28625
- Recruiting
Accellacare of Piedmont HealthCare
Statesville, North Carolina, 28625
- Recruiting
Central States Research
Tulsa, Oklahoma, 74136
- Recruiting
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, 20016
- Recruiting
Accellacare US Inc.
Winston-Salem, North Carolina, 27103
About this study
Official title: 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
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:
Read more
- 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
- Being tested
- Zavegepant
- Keywords
- migraine, zavegepant, pediatric
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZavegepantDrug
Zavegepant 5 mg or 10 mg (dose is weight-dependent)
| Study group | Role | What they receive |
|---|---|---|
| Zavegepant | Experimental | Experimental medicine under study Receives: Drug: Zavegepant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Cmax is defined as the maximum observed plasma concentration of zavegepant after administration of a single dose
Measured: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tmax is defined as the time to reach maximum observed plasma concentration
Measured: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours
Area Under the Curve From Time Zero to infinity.
AUC (0 - inf) is defined as area under the concentration-time curve from time 0 to infinity.
Measured: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours
Secondary outcomes (4)
Number of Participants with All-Causality Treatment-emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship with the study intervention. SAE is defined as one of the following: is fatal or life threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; is medically significant; requires inpatient hospitalization or prolongation of existing hospitalization. Treatment-emergent AE is defined as an AE with onset date occurring during the on-treatment period. AEs include all SAEs and non-SAEs.
Measured: TEAE is reported from informed consent up to 28 days after administration of study drug.
Number of participants with clinically significant abnormal vital signs
Vital sign measurements include temperature, respiratory rate, pulse rate, and blood pressure.
Measured: Assessed from screening up to 6 days after administration of study drug
Number of participants with clinically significant abnormal laboratory findings
Laboratory assessment includes hematology, chemistry and urinalysis. Clinical significance of laboratory abnormalities was judged by investigator.
Measured: Assessed from screening up to 6 days after administration of study drug
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. The C-SSRS assessment MUST be performed by an adequately trained, certified, and delegated rater. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of "yes" on "actual attempt"), 3: preparatory acts toward imminent suicidal behavior ("yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), 4: any suicidal behavior or ideation, suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent"), 7: self-injurious behavior, no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior").
Measured: Assessed from screening up to 6 days after administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start16 May 2025
- Primary completion12 Aug 2027 (estimated)
- Study completion12 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Treatment of MigraineStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995729
- Sponsor's protocol ID
- C5301023
- Status last verified
- Sep 2026
- First submitted
- 7 May 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.