Clinical trial NCT04571060
Conditions: Migraine
Keywords: Acute Migraine Phonophobia Photophobia Nausea
Sponsor: Pfizer
Start date: 2020-10-27; Completion date: 2021-10-22
Enrollment: 1978 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the safety and efficacy of BHV-3500 (zavegepant) versus placebo in the acute treatment of moderate or severe migraine.

Detailed description:

Arms: arm 1: Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar Unidose System (UDS) liquid spray device. arm 2: Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.
Interventions: intervention 1: Zavegepant intervention 2: Placebo
Intervention descriptions: intervention 1: One dose of zavegepant intervention 2: One dose of matching placebo

Protocol documents:
Prot_000.pdf: 
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