Status:
COMPLETED
A Study to Learn About Zavegepant as the Acute Treatment of Migraine in Asian Adults
Lead Sponsor:
Pfizer
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to learn how safe and effective zavegepant is compared to placebo in the acute treatment of migraine in Asian adults. Migraine is a very painful headache with other associ...
Eligibility Criteria
Inclusion
- Asian participants aged 18 years or older at screening.
- Participants with minimum 1 year history of migraine (with or without aura) prior to the Screening Visit, consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
- Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
- Migraine attacks, on average, lasting about 4-72 hours if untreated.
- Not more than 8 attacks of moderate or severe pain intensity per month within last 3 months.
- Participants must be able to distinguish migraine attacks from tension/cluster headaches.
- At least 2 consistent migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and throughout the Screening Phase (participant self-report).
- Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase (participant self-report).
- Participants on prophylactic migraine medication are permitted to remain on therapy if they have been on a stable dose for at least 3 months prior to Screening Visit, and if the dose is not expected to change through the End of Treatment Visit.
- Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.
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, anxiety disorder, or other significant psychiatric disorder.
- Acute or chronic pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that interfere with study assessments.
- Conditions that may affect the administration or absorption of the nasal product.
- Medication overuse headaches.
Key Trial Info
Start Date :
November 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
1414 Patients enrolled
Trial Details
Trial ID
NCT05989048
Start Date
November 29 2023
End Date
May 30 2025
Last Update
August 13 2025
Active Locations (61)
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1
The Second People's hospital of Hefei
Hefei, Anhui, China, 230011
2
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
3
The First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
4
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016