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Completed

NCT Number: NCT06019338

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

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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ULC Research, London, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain Diary use

Other

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

Primary outcomes

  1. 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. 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

Sponsors and collaborators

Lead sponsor

Noema Pharma AG

Industry

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2023
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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