Phase 3
Completed N=608
Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine
Acute Migraine
Source: ClinicalTrials.gov NCT04408794 ↗
Enrolled (actual)
608
Serious AEs
1.2%
Results posted
Mar 2023
Primary outcomePrimary: Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading To Discontinuation — 460; 7; 41 Participants
◆ Published Evidence
Emerging
10citations · ~5 / year
Long-term safety of zavegepant nasal spray for the acute treatment of migraine: A phase 2/3 open-label study.
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 "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.
Linked Publications (3)
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Long-term safety of zavegepant nasal spray for the acute treatment of migraine: A phase 2/3 open-label study.
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Long-term safety and tolerability of zavegepant 10-mg nasal spray with concomitant use of anti-calcitonin gene-related peptide monoclonal antibodies or other select preventive migraine medications: Results from a phase 2/3 open-label study.
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Patient-Reported Outcomes During the Acute Treatment of Migraine with Zavegepant Nasal Spray: Results from a 52-Week, Open-Label Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading To Discontinuation |
460; 7; 41 | — |
| PRIMARY Number Of Participants With Clinically Significant Laboratory Abnormalities |
3; 5; 0; 0; 0; 0 | — |
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%
Data sourced from ClinicalTrials.gov (NCT04408794) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.