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

Completed

• Conditions: Trigeminal Neuralgia

• Registration Number: NCT06019338
• Lead Sponsor: Noema Pharma AG

Brief 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.

Study Timeline

• Study Start: 2021-11-20
• Study First Submitted: 2022-05-01
• Study First Submitted QC: 2023-08-29
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Study First Posted: 2023-08-31
• Status Verified: 2023-11
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Male or Female aged of 40 years or more.
• Must be able to read, write, and speak English to complete the consent process and participate in an interview.
• Able and willing to provide consent for participation in the study, and to allow the study team to access their data entries including audio or video recordings. - - Participant with a current or previous diagnosis of TN
• Willing to participate in up to 30 minutes remote interviews or in-person interview (this interview will be recorded by the HCP)
• Committ to fill in the diary according to the HCP instruction

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure of pain associated with Trigeminal Neuralgia	2 weeks	Use of the TN Pain questionnaire to measure the pain associated with trigeminal neuralgia
Concept elicitation of the diary content	1 day	During an interview, assess if the questionnaire is comprehensive, clear and correctly captures patients experience

Trial Locations

Locations (2)

ULC Research; 🇬🇧 London, United Kingdom

Kainzen Centre; 🇺🇸 La Jolla, California, United States