NCT06019338

A Study to Validate a Pain Diary for Patient With Trigeminal Neuralgia

A Study to Validate a Diary Developed by Noema Pharma That Will be Used for Future Trigeminal Neuralgia Clinical Research Studies to Capture Pain Dimensions.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Noema Pharma AG · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
OTHER	Pain Diary use	Validation of a pain diary specifically designed to capture pain dimensions of Trigeminal Neuralgia

Timeline

• Start date: 2021-11-20
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2023-08-31
• Last updated: 2024-12-10

Locations

2 sites across 2 countries: United States, United Kingdom