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Automated Variable Pattern Insufflator Device (AVPI) for the Acute Treatment of Migraine

Migraine Headache Clinical Trial

Official title:
Automated Variable Pattern Insufflator Device (AVPI) for the Acute Treatment of Migraine: a Prospective, Randomized, Double-blind, Parallel Group, Sham-controlled Clinical Trial

Clinical Trial Summary

Randomized, sham-controlled, double-blind study for acute migraine attacks. Randomized to active treatment and sham treatment arms for the first treatment. Optional second active treatment. Follow up at 0, 2 and 24 hours post-treatment.

Clinical Trial Description

Randomized, sham-controlled, double-blind study for acute migraine attacks. Treatment Phase: • ≤60 days to present at clinic for treating up to 2 migraines (at least 48 hours apart). First treatment is randomized between active treatment and sham treatment. Second optional treatment is open-label. Post-Treatment Follow-up Phase: - 24 hours after initiating treatment, for each of up to two migraine treatments, for conducting post-treatment follow-up assessments of migraine symptoms. - 30, 60, and 90 days following the first migraine treatment for migraine diary assessments (and MIDAS assessment at 90 days) Collection of migraine diaries at 30, 60, & 90 days post enrollment. Collection of MIDAS data at 60 and 90 days post treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04584762
Study type Interventional
Source Nocira, LLC
Contact
Status Active, not recruiting
Phase N/A
Start date March 9, 2020
Completion date October 31, 2022
View Details
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