Trigeminal NeuralgiaNCT03656497
Classical Trigeminal Neuralgia and Sodium Channel Mutations
An observational study of Trigeminal Neuralgia, run by Danish Headache Center.
Trial summary
The most common cause of trigeminal neuralgia is considered to be a neurovascular contact. However, this etiological factor only seem to be present in half of the patient group. Thus the etiology of the other half is unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Observational
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2015to 1 Aug 2018
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from trigeminal neuralgia and has an onset of disease before the age of 42 and/or first-line relative with TN.
3.1. Inclusion Criteria
Subjects of both sexes with TN must meet the following inclusion criteria to be eligible for participation:
- Patients must be able to give Signed Informed Consent prior to study entry
- Patients fulfilling of the ICHD-3 beta diagnostic criteria for classical TN.1
- Age 18 years or older.
- Age at debut < 42 years and/or confirmed first-line relative with TN.
- Respond to sodium channel blockers with a 50% reduction of pain intensity evaluated by both the patient and the examining physician using the visual analog scale (VAS).
3.2. Exclusion Criteria
Subjects will be excluded if one of the following exclusion criteria is met:
- Psychiatric or mental illness of physical condition that might interfere with the ability of the patients to fill in the Informed Consent and questionnaires.
- History of herpes zoster in the distribution of the trigeminal nerve ipsilateral to pain, multiple sclerosis or a space-occupying lesion.
- History indicative of painful posttraumatic trigeminal neuropathy such as previous trauma, surgery or radiation to the trigeminal nerve ipsilateral to pain.
About this study
The most common cause of trigeminal neuralgia is considered to be a neurovascular contact. However, this etiological factor only seem to be present in half of the patient group. Thus the etiology of the other half is unknown.
Gain-of function genetic mutations in voltage gated sodium channels have been hypothesized as playing a role in the etiology of trigeminal neuralgia but it has yet to be confirmed. In recent years gain-of-function mutations have been identified as a causative factor in other pain-diseases presenting with trigeminal neuralgia phenotypic similarities.
Read the detailed description
The aim of this study was to indentify VGSC gene mutations, specifically SCN9A, SCN10A and SCN11A genes, in a group of well characterized trigeminal neuralgia patients.
Setting: The study will be conducted at The Danish Headache Center, Rigshospitalet - Glostrup, Denmark (inclusion of patients and written Informed Consent, patient interview, phenotyping/diagnosis, neurological examination, blood sample.
Departments of Neurology and Clinical Genomics of the Maastricht University Medical Center, Maastricht, the Netherlands: Targeted NG Sanger Sequencing
- Conditions
- Trigeminal Neuralgia
- Being tested
- Observational
- Keywords
- genetic mutations, voltage gated sodium channels, phenotype,
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
No intervention is conducted as the study aim is to explore the link between pheno- and genetype of trigeminal neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploratory study of association between phenotype and genotype of trigeminal neuralgia
To identify genetic mutations, via Sanger Next Generation Sequencing, in either NaV 1.7, NaV1.8 or NaV1.9 encoding genes and link the findings to the phenotype of trigeminal neurlagia patients with a high genetic load.
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 posted4 Sep 2018
- Study start1 Nov 2015
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Enrolment
- 33 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center
- Responsible party
- Principal investigator, Tone Heinskou, Danish Headache Center
- Investigators
- Lars Bendtsen, ass. prof., Study chair, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656497
- Sponsor's protocol ID
- H-15010165
- Status last verified
- Aug 2018
- First submitted
- 29 Aug 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classical Trigeminal Neuralgia and Sodium Channel Mutations
- ClinicalTrials.gov ID
- NCT03656497
- Acronym / sponsor ID
- H-15010165
- Conditions
- Trigeminal Neuralgia
- Keywords
- genetic mutations, voltage gated sodium channels, phenotype,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 4 Sep 2018 (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 most common cause of trigeminal neuralgia is considered to be a neurovascular contact. However, this etiological factor only seem to be present in half of the patient group. Thus the etiology of the other half is unknown.
Gain-of function genetic mutations in voltage gated sodium channels have been hypothesized as playing a role in the etiology of trigeminal neuralgia but it has yet to be confirmed. In recent years gain-of-function mutations have been identified as a causative factor in other pain-diseases presenting with trigeminal neuralgia phenotypic similarities.
Detailed description
The aim of this study was to indentify VGSC gene mutations, specifically SCN9A, SCN10A and SCN11A genes, in a group of well characterized trigeminal neuralgia patients.
Setting: The study will be conducted at The Danish Headache Center, Rigshospitalet - Glostrup, Denmark (inclusion of patients and written Informed Consent, patient interview, phenotyping/diagnosis, neurological examination, blood sample.
Departments of Neurology and Clinical Genomics of the Maastricht University Medical Center, Maastricht, the Netherlands: Targeted NG Sanger Sequencing
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from trigeminal neuralgia and has an onset of disease before the age of 42 and/or first-line relative with TN.
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 |
|---|---|---|
| ObservationalNo intervention is conducted as the study aim is to explore the link between pheno- and genetype of trigeminal neuralgia | Other | – |
Primary outcome
Exploratory study of association between phenotype and genotype of trigeminal neuralgia
Time frame: 1 day
To identify genetic mutations, via Sanger Next Generation Sequencing, in either NaV 1.7, NaV1.8 or NaV1.9 encoding genes and link the findings to the phenotype of trigeminal neurlagia patients with a high genetic load.
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 5 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
Lars Bendtsen, ass. prof. study chair
Danish Headache Center
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Neuralgia, run by Danish Headache Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Exploratory study of association between phenotype and genotype of trigeminal neuralgia (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2018.