Trigeminal NeuralgiaNCT06019338
A Study to Validate a Pain Diary for Patient With Trigeminal Neuralgia
An observational study of Trigeminal Neuralgia, run by Noema Pharma AG at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Pain Diary use
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Nov 2021to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients or former patients with diagnosed trigeminal neuralgia
Who may be able to join
- 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
Who cannot join
- Not applicable
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
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.
Read the 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.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Pain Diary use
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Diary useOther
Validation of a pain diary specifically designed to capture pain dimensions of Trigeminal Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of pain associated with Trigeminal Neuralgia
Use of the TN Pain questionnaire to measure the pain associated with trigeminal neuralgia
Measured: 2 weeks
Concept elicitation of the diary content
During an interview, assess if the questionnaire is comprehensive, clear and correctly captures patients experience
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start20 Nov 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noema Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Director, Study director, Noema Pharma AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019338
- Sponsor's protocol ID
- NOE-PRO-001
- Status last verified
- Nov 2023
- First submitted
- 1 May 2022
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42220290
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06019338
- Acronym / sponsor ID
- NOE-PRO-001
- Conditions
- Trigeminal Neuralgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Noema Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients or former patients with diagnosed trigeminal neuralgia
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Diary useValidation of a pain diary specifically designed to capture pain dimensions of Trigeminal Neuralgia | Other | – |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Derived from this study: PubMed 42220290Tahiri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Director study director
Noema Pharma AG
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Neuralgia, run by Noema Pharma AG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of pain associated with Trigeminal Neuralgia (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06019338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.