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

December 5, 2024 updated by: Noema Pharma AG

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • ULC Research
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Kainzen Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients or former patients with diagnosed trigeminal neuralgia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Noema Pharma AG

Investigators

  • Study Director: Clinical Director, Noema Pharma AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2021

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

May 1, 2022

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOE-PRO-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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