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

NCT06019338 | Completed

• 1 other identifier: NOE-PRO-001
• Study Type: observational
• Target: 30
• Locations: 2 countries
• Sites: 2

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. 1.To generate evidence to support diary content validity by performing qualitative research studies with TN patients and Healthcare Professionals (HCPs).
2. 2.To provide further support to the diary, sensitivity to change, known groups validity (ability to differentiate between severity groups), and construct validity.

Conditions

Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (2)

• Measure of pain associated with Trigeminal Neuralgia

  Use of the TN Pain questionnaire to measure the pain associated with trigeminal neuralgia

  2 weeks

• Concept elicitation of the diary content

  During an interview, assess if the questionnaire is comprehensive, clear and correctly captures patients experience

  1 day

Interventions

Pain Diary use OTHER

Validation of a pain diary specifically designed to capture pain dimensions of Trigeminal Neuralgia

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients or former patients with diagnosed trigeminal neuralgia

You may qualify if:

• 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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Noema Pharma AG: lead

Study Sites (2)

Kainzen Centre

La Jolla, California, 92037, United States

Location

ULC Research

London, United Kingdom

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Clinical Director

  Noema Pharma AG

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2022
• First Posted: August 31, 2023
• Study Start: November 20, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: December 10, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (1)