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

NCT04408794

CompletedPhase 2, Phase 3

Sponsor: Pfizer

Conditions: Acute Migraine

Interventions: Zavegepant (BHV-3500)

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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%
Locations (67)
  • Huntsville, Alabama, United States
  • Mobile, Alabama, United States
  • Tucson, Arizona, United States
  • Little Rock, Arkansas, United States
  • Encino, California, United States
  • La Mesa, California, United States
  • Lemon Grove, California, United States
  • Long Beach, California, United States
  • Los Alamitos, California, United States
  • Newport Beach, California, United States
  • San Diego, California, United States
  • San Marcos, California, United States
  • Santa Monica, California, United States
  • Sherman Oaks, California, United States
  • Cromwell, Connecticut, United States
  • Stamford, Connecticut, United States
  • Jacksonville, Florida, United States
  • Lake City, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Ormond Beach, Florida, United States
  • Tampa, Florida, United States
  • Decatur, Georgia, United States
  • Savannah, Georgia, United States
  • Boise, Idaho, United States
  • Anderson, Indiana, United States
  • Fort Wayne, Indiana, United States
  • Prairie Village, Kansas, United States
  • Chalmette, Louisiana, United States
  • Boston, Massachusetts, United States
  • + 37 more on CT.gov