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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-20

Study Completion Date

2023-08-31

Brief Summary

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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

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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.

Conditions

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Trigeminal Neuralgia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Pain Diary use

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Director

Role: STUDY_DIRECTOR

Noema Pharma AG

Locations

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Kainzen Centre

La Jolla, California, United States

Site Status

ULC Research

London, , United Kingdom