Status:
COMPLETED
Acute Treatment Trial in Adult Subjects With Migraines
Lead Sponsor:
Pfizer
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of the study is to evaluate the safety and efficacy of three different intranasal dose levels of zavegepant (BHV-3500), relative to placebo, in the acute treatment of moderate to severe mi...
Eligibility Criteria
Inclusion
- Key
- 1\. Participants have at least 1-year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 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 to severe intensity per month within the last 3 months.
- 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 Period.
- Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Period.
- Participants on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to Screening Visit and the dose is not expected to change during the course of the study.
- Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.
Exclusion
- Key
Key Trial Info
Start Date :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2019
Estimated Enrollment :
2154 Patients enrolled
Trial Details
Trial ID
NCT03872453
Start Date
March 25 2019
End Date
November 11 2019
Last Update
September 25 2023
Active Locations (82)
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1
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
2
Elite Clinical Studies
Phoenix, Arizona, United States, 85018
3
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States, 72205
4
Pharmacology Research Institute
Encino, California, United States, 91316