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New treatment option for Acute Treatment of Migraine
Official title A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine
ClinicalTrials.gov ID: NCT06995729
What this study is testing
What is Zavegepant?
Zavegepant is an investigational medicine, being studied as a potential treatment for acute treatment of migraine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 10 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 11
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility criteria
- 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
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Washington D.C., District of Columbia, United States
- Hinesville, Georgia, United States
- Minneapolis, Minnesota, United States
- Omaha, Nebraska, United States
- Port Jefferson Station, New York, United States
- Statesville, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Tulsa, Oklahoma, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Washington D.C., District of Columbia, United States; Hinesville, Georgia, United States; Minneapolis, Minnesota, United States; Omaha, Nebraska, United States; Port Jefferson Station, New York, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.