Condition: Acute Migraine · Sponsor: Pfizer
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.
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.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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.
| Medical Affiliated Research Center | Huntsville, Alabama, United States | — |
| 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 | — |
+ 55 more locations — full list on the registry record.
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