Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine

Completed · Phase 2/Phase 3

Conditions studied: Acute Migraine

In brief

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 "zavegepant" (za ve' je pant). The World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee revised the name to "zavegepant" which was accepted by the United States Adopted Names (USAN ) Council for use in the U.S. and is pending formal adoption by the INN for international use.

Key facts

Study ID

NCT04408794

Run by

Pfizer

People needed

974

Starts

2020-06-29

Expected to finish

2021-12-23

Last updated by the study team

2023-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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%

Where it is running

• Coastal Clinical Research, LLC, An AMR Co. — Mobile, Alabama, United States
• Tucson Neuroscience Research — Tucson, Arizona, United States
• Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
• Pharmacology Research Institute — Encino, California, United States
• eStudySite — La Mesa, California, United States
• Synergy San Diego — Lemon Grove, California, United States
• Collaborative Neuroscience Network, LLC — Long Beach, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• Wr-Pri, Llc — Newport Beach, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Artemis Institute for Clinical Research — San Marcos, California, United States
• California Medical Clinic for Headache — Santa Monica, California, United States
• California Neuroscience Research Medical Group, Inc. — Sherman Oaks, California, United States
• CT Clinical Research — Cromwell, Connecticut, United States
• Ki Health Partners, LLC dba New England Institute for Clinical Research — Stamford, Connecticut, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Multi-Specialty Research Associates, Inc. — Lake City, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Ormond Medical Arts Pharmaceutical Research Center — Ormond Beach, Florida, United States
• Meridien Research — Tampa, Florida, United States
• iResearch Atlanta, LLC — Decatur, Georgia, United States
• Meridian Clinical Research, LLC — Savannah, Georgia, United States
• Northwest Clinical Trials Inc. — Boise, Idaho, United States
• Medical Affiliated Research Center — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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