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

Pfizer

Status and phase: Completed; Phase 3; Phase 2

Conditions: Acute Migraine

Treatments: Drug: Zavegepant (BHV-3500)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04408794

C5301029 (Other Identifier)

BHV3500-202

Details and patient eligibility

About

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.

Enrollment: 974 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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974 participants in 1 patient group

Zavegepant (BHV-3500)

Experimental group

Description:

10 mg intranasal (IN) up to 8 times per month, up to 1 year

Treatment:

Drug: Zavegepant (BHV-3500)