Status:
NOT_YET_RECRUITING
A Study to Learn About Zavegepant as a Treatment for Multiple Migraine Attacks in Adult Participants
Lead Sponsor:
Pfizer
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study to show that zavegepant 10 milligrams given through the nose provides: * freedom from pain, 2 hours after taking the medicine for the first migraine attack. * consistent fre...
Eligibility Criteria
Inclusion
- Participants aged 18 years or older.
- Participants with minimum 1 year history of migraine with age onset before 50 years of age.
Exclusion
- History of retinal migraine, basilar migraine or hemiplegic migraine.
- History or current evidence of uncontrolled, unstable or recently diagnosed cardiovascular or cardiometabolic disease.
- Major depressive disorder or anxiety disorder.
- Acute or chronic pain syndromes.
- Conditions that may affect the administration or absorption of the nasal product.
- History of alcohol abuse and/or illicit drug.
- Other social, medical, or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Current use of any prohibited concomitant medication(s) or participants unwilling/unable to use a permitted concomitant medication(s)
- History of use of ergotamine medications or triptans on greater than/equal to 10 days per month on a regular basis for greater than/equal to 3 months. Or history of non-narcotic analgesic intake on greater than/equal to 15 days per month for greater than/equal to 3 months for other pain indications.
- Participation in clinical trial with non-biological investigational agents or interventional treatments (last study visit occurring) within the 30 days prior to Baseline Visit.
- Participation in clinical trial with biological investigational agents (last study visit occurring) within 90 days prior to Baseline Visit. Participation in any other investigational clinical trial while participating in this clinical trial.
- Previous participation in any zavegepant study within the last 2 years.
- ANY of the following findings at the Screening Visit and laboratory tests as assessed by the study-specific laboratory:
- Class 2 or Class 3 obesity, defined as body mass index \>35 kg/m2.
- Estimated Globular Filtration Rate \<30 mL/min/1.73 m2.
- Total bilirubin ≥1.5 × upper limit of normal.
- Liver transaminases ≥2.0 × upper limit of normal .
- Neutrophil count ≤1000/μL (or equivalent).
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 2 2027
Estimated Enrollment :
1280 Patients enrolled
Trial Details
Trial ID
NCT06103734
Start Date
September 15 2025
End Date
August 2 2027
Last Update
July 2 2025
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