CClinicalTrials.gg
CompletedNCT03656497Updated Sep 5, 2018

Classical Trigeminal Neuralgia and Sodium Channel Mutations

An observational study in Trigeminal Neuralgia, sponsored by Danish Headache Center. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by Danish Headache Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
33
Ages
18 Years and older
Sex
All
01

Study 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.

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

02

Conditions studied

  • Trigeminal Neuralgia

Keywords

  • genetic mutations, voltage gated sodium channels, phenotype,
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In context

Trigeminal Neuralgia

135 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.

This study's enrollment of 33 is below the median of 82 across 34 observational studies indexed under Trigeminal Neuralgia.

Browse Trigeminal Neuralgia studies →

Lead sponsor

Danish Headache Center is the lead sponsor of 125 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

Subjects of both sexes with TN must meet the following inclusion criteria to be eligible for participation:

  1. Patients must be able to give Signed Informed Consent prior to study entry
  2. Patients fulfilling of the ICHD-3 beta diagnostic criteria for classical TN.1
  3. Age 18 years or older.
  4. Age at debut \< 42 years and/or confirmed first-line relative with TN.
  5. 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).

Exclusion criteria

3.2. Exclusion Criteria

Subjects will be excluded if one of the following exclusion criteria is met:

  1. Psychiatric or mental illness of physical condition that might interfere with the ability of the patients to fill in the Informed Consent and questionnaires.
  2. History of herpes zoster in the distribution of the trigeminal nerve ipsilateral to pain, multiple sclerosis or a space-occupying lesion.
  3. History indicative of painful posttraumatic trigeminal neuropathy such as previous trauma, surgery or radiation to the trigeminal nerve ipsilateral to pain.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
33 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples with dna

Interventions

  • OtherObservational

    No intervention is conducted as the study aim is to explore the link between pheno- and genetype of trigeminal neuralgia

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03656497
Lead sponsor
Danish Headache Center
Collaborators
Maastricht University Medical Center
Responsible party
Tone Heinskou (MD, PhD student, Danish Headache Center) — Principal investigator
First posted
Sep 4, 2018
Start date
Nov 1, 2015
Primary completion
Aug 1, 2018
Completion
Aug 1, 2018
Last update
Sep 5, 2018

Study contacts

Lars Bendtsen, ass. prof.
study chair · Danish Headache Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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