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Clinical Trial Summary

The aim of the study is to establish the validity of a patient reported diary in TN . The following objectives have been identified: 1. To generate evidence to support diary content validity by performing qualitative research studies with TN patients and Healthcare Professionals (HCPs). 2. To provide further support to the diary, sensitivity to change, known groups validity (ability to differentiate between severity groups), and construct validity.


Clinical Trial Description

This study will engage up to 20 participants with TN through patient associations or HCPs. The study will be conducted in English Speaking countries. The study comprises the following parts : - Participants Recruitment - Completion of the Diary - Qualitative interviews with participants - Analysis of qualitative research to assess content validity - Secondary analysis as a workshop with a panel of experts to finalize the diary The diary will be provided to each participant and to HCPs. Participants will be requested to follow the instructions, use the diary and provide their feedback on the diary. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06019338
Study type Observational
Source Noema Pharma AG
Contact
Status Completed
Phase
Start date November 20, 2021
Completion date August 31, 2023

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