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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zavegepant | Experimental | Experimental medicine under study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zavegepant | Drug | Zavegepant 5 mg or 10 mg (dose is weight-dependent) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Cmax is defined as the maximum observed plasma concentration of zavegepant after administration of a single dose | 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 | 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. | Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Not yet recruiting | Little Rock | Arkansas | 72202 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| 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. | 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. | 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"). | Assessed from screening up to 6 days after administration of study drug |
| Velocity Clinical Research, Washington DC |
| Not yet recruiting |
| Washington D.C. |
| District of Columbia |
| 20016 |
| United States |
| Coastal Heritage Clinical Research | Recruiting | Hinesville | Georgia | 31313 | United States |
| Clinical Research Institute | Not yet recruiting | Minneapolis | Minnesota | 55402 | United States |
| Children's Hospital & Medical Center | Recruiting | Omaha | Nebraska | 68114 | United States |
| True North Neurology | Not yet recruiting | Port Jefferson Station | New York | 11776 | United States |
| Accellacare - Piedmont | Recruiting | Statesville | North Carolina | 28625 | United States |
| Accellacare of Piedmont HealthCare | Recruiting | Statesville | North Carolina | 28625 | United States |
| Accellacare US Inc. | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
| Central States Research | Recruiting | Tulsa | Oklahoma | 74136 | United States |
| Cedar Health Research | Recruiting | Dallas | Texas | 75251 | United States |
| Wasatch Clinical Research, LLC | Recruiting | Salt Lake City | Utah | 84107 | United States |
| Granger Medical Holladay - Holladay Clinic | Recruiting | Salt Lake City | Utah | 84117 | United States |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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