A Study to Validate a Pain Diary for Patient With Trigemi... | NCT06019338

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

NCT06019338

Sponsor

Noema Pharma AG

Status

Completed

Last Update Posted

Dec 10, 2024Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Trigeminal Neuralgia

Interventions

Pain Diary use

Countries

United States
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2021Actual

Primary Completion Date

Aug 31, 2023Actual

Completion Date

Aug 31, 2023Actual

First Submitted Date

May 1, 2022

First Submission Date that Met QC Criteria

Aug 29, 2023

First Posted Date

Aug 31, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2024

Last Update Posted Date

Dec 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pain Diary use	Other	Validation of a pain diary specifically designed to capture pain dimensions of Trigeminal Neuralgia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients or former patients with diagnosed trigeminal neuralgia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Director	Noema Pharma AG	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kainzen Centre		La Jolla	California	92037	United States
ULC Research

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42220290	Derived	Tahiri AS, Dodhia SA, Chotaliya S, Ansari H, Garibaldi G, Lasser R, Zakrzewska JM. Qualitative validation of TnED(c), an electronic instrument capturing pain dimensions in patients with trigeminal neuralgia. J Oral Facial Pain Headache. 2026 May;40(3):83-92. doi: 10.22514/jofph.2026.038. Epub 2026 May 12.

ID	Term
D020433	Trigeminal Nerve Diseases
D005156	Facial Neuralgia
D005155	Facial Nerve Diseases
D009059	Mouth Diseases