Migraine Clinical Trial
Official title:
Automated Variable Pattern Insufflator Device (AVPI) for the Acute Treatment of Migraine: a Multicenter, Double-blind, Randomized, Sham-controlled Trial
The study is designed as a multicenter, double-blind, randomized, sham-controlled trial to assess the safety and effectiveness of the Nocira AVPI Device for the acute treatment of migraine. The study is conducted in two phases in two study groups: - Phase I - initial screening of device operation in both active and sham modes in-clinic and as proctored by the investigator, and - Phase II - for further evaluation when used in the home (non-clinical) environment.
The study is designed as a multicenter, double-blind, randomized, sham-controlled trial to assess the safety and effectiveness of the Nocira AVPI Device for the acute treatment of migraine. The study is conducted in two phases in two study groups: - Phase I - initial screening of device operation in both active and sham modes in-clinic and as proctored by the investigator, and - Phase II - for further evaluation when used in the home (non-clinical) environment. The timing of enrollments into each group will vary between sequentially timed Phases I & II. Group 1 subjects may participate in both Phases. Group 2 subjects participate only in Phase II. Group 1 subjects may participate for up to 90 days (45 days for each of Phases I&II). Group 2 subjects will participate for up to 45 days. ;
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