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

Sponsor

Noema Pharma AG (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT06019338

Collaborator

(none)

Enrollment

Locations

21.3

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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:

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

Condition or Disease	Intervention/Treatment	Phase
Trigeminal Neuralgia	Other: Pain Diary use

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 Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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.

Actual Study Start Date :

Nov 20, 2021

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kainzen Centre	La Jolla	California	United States	92037
2	ULC Research	London		United Kingdom

Sponsors and Collaborators

Noema Pharma AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Noema Pharma AG

ClinicalTrials.gov Identifier:

NCT06019338

Other Study ID Numbers:

NOE-PRO-001

First Posted:

Aug 31, 2023

Last Update Posted:

Aug 31, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Trigeminal Neuralgia

Neuralgia

Study Results

No Results Posted as of Aug 31, 2023