Status:
COMPLETED
Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine
Lead Sponsor:
Pfizer
Conditions:
Acute Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the long-term safety of BHV-3500/vazegepant intranasal in the acute treatment of migraine. \* BHV-3500, formerly "vazegepant", is now referred to as "zavegepa...
Eligibility Criteria
Inclusion
- 2-8 moderate to severe migraines/month within the last 3 months
- Migraine attacks present for more than 1 year with age of onset of migraines prior to 50 years of age
- Migraine attacks, on average, lasting about 4-72 hours if untreated
- Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the screening visit
- Ability to distinguish migraine attacks from tension/cluster headaches
- Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria
Exclusion
- History of human immunodeficiency virus disease
- History of basilar or hemiplegic migraine
- Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder
- History of nasal surgery in the 6 months preceding the screening visit
- History of gallstones or cholecystectomy
- History of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etcetera), or other disease or condition (for example, chronic pancreatitis, ulcerative colitis, etcetera) that causes malabsorption.
- Body mass index ≥ 33
- Hemoglobin A1c ≥6.5%
Key Trial Info
Start Date :
June 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2021
Estimated Enrollment :
974 Patients enrolled
Trial Details
Trial ID
NCT04408794
Start Date
June 29 2020
End Date
December 23 2021
Last Update
May 18 2023
Active Locations (67)
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1
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
2
Coastal Clinical Research, LLC, An AMR Co.
Mobile, Alabama, United States, 36608
3
Tucson Neuroscience Research
Tucson, Arizona, United States, 85710
4
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States, 72205