Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT05537818
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT05537818
Study Brief:
Protocol Section:
NCT05537818