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Study identifier: NCT04408794 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Completed

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

Condition: Acute Migraine  ·  Sponsor: Pfizer

PhasePhase 2/Phase 3
Planned participants974
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where67 locations

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: * 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 Criteria: * 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%

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (67)

Medical Affiliated Research CenterHuntsville, Alabama, United States
Coastal Clinical Research, LLC, An AMR Co.Mobile, Alabama, United States
Tucson Neuroscience ResearchTucson, Arizona, United States
Baptist Health Center for Clinical ResearchLittle Rock, Arkansas, United States
Pharmacology Research InstituteEncino, California, United States
eStudySiteLa Mesa, California, United States
Synergy San DiegoLemon Grove, California, United States
Collaborative Neuroscience Network, LLCLong Beach, California, United States
Pharmacology Research InstituteLos Alamitos, California, United States
Wr-Pri, LlcNewport Beach, California, United States
Artemis Institute for Clinical ResearchSan Diego, California, United States
Artemis Institute for Clinical ResearchSan Marcos, California, United States

+ 55 more locations — full list on the registry record.

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