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

Trigeminal Neuralgia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06019338
• Other study ID #: NOE-PRO-001
• Status: Completed
• Start date: November 20, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: November 2023
• Source: Noema Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Other:
• Pain Diary use
Validation of a pain diary specifically designed to capture pain dimensions of Trigeminal Neuralgia

Locations

Country	Name	City	State
United Kingdom	ULC Research	London
United States	Kainzen Centre	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Noema Pharma AG

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

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