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Neuropathic PainGeNeupNCT03862365

Exploring the Genetics of Neuropathic Pain

An observational study of Neuropathic Pain and Genetic Predisposition, run by Oslo University Hospital at 5 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

In the present study the investigators will search for new genetic variants relevant for the development of neuropathic pain. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Nerve conduction Studies
How many people
5,000 participants
Where
5 sitesNorway
Study dates
1 Aug 2018to 31 Dec 2027
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients that are referred for suspected distal symmetric polyneuropathy and meet the inclusion criteria, will be included in the project. Furthermore, there will be collected blood tests from patients with definite and probable polyneuropathy.

Who may be able to join

  • The patient is between 18 and 70 years old.
  • The patient has consented.
  • The patient is referred for evaluation of possible distal symmetric polyneuropathy (DSPN).
  • The patient has filled out the questionnaires.

Who cannot join

  • The patient is too sick to participate (eg. bedridden, fever).
  • The patient is unable to consent (eg. dementia, speech problems, psychiatric disorder).
  • Inflammatory acute polyneuropathy.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kristian B. Nilsen, M.D contact

+4791372241

uxnikq@ous-hf.no

5 sites in 1 country

Norway5 sites, 5 recruiting

  • Haukeland University Hospital

    Bergen, 5021

    Ina Hjelland, M.D., +4755975000, ina.hjelland@helse-bergen.no

    Recruiting

  • Oslo University Hospital

    Oslo, 0450

    Kristian B. Nilsen, M.D., +4791372241, uxnikq@ous-hf.no

    Øystein Dunker, M.D., +4793293484, anoyes@ous-hf.no

    Recruiting

  • Helse Stavanger HF

    Stavanger, 4011

    Marie Bu Kvaløy, M.D., +4751518430, marie.bu.kvaloy@sus.no

    Recruiting

  • University Hospital of North Norway

    Tromsø, 9019

    Sissel Løseth, M.D., +4777627102, sissel.loseth@unn.no

    Recruiting

  • St. Olavs Hospital

    Trondheim, 7030

    Trond Sand, M.D., +4772576006, trond.sand@ntnu.no

    Recruiting

Other trials in Norway

About this study

In the present study the investigators will search for new genetic variants relevant for the development of neuropathic pain.

Read the detailed description

Neuropathic pain is defined as "pain caused by a lesion or disease of the somatosensory nervous system". Neuropathic pain is a huge health problem worldwide, with an estimated prevalence of 7-8 % in the general population. In the present study the investigators will search for new genetic variants relevant for the development of this type of pain.

Peripheral nerve lesions only progress to neuropathic pain in some patients, yet is not completely understood why or how. Genetic studies of patients with rare neuropathic disorders have been important for elucidating novel molecular mechanisms of neuropathic pain, and new drugs for neuropathic pain are now being developed based on these findings. By using genetic association studies, one may identify new genetic variants which may help to identify key molecular mechanisms for a larger group of patients with neuropathic pain.

This project will use existing population-based cohorts, as well as establish a specific registry and biobank for patients with neuropathy in order to address these specific needs. This will allow the investigators to identify a large number of individuals with probable neuropathic pain and individuals with pain-free peripheral neuropathy (disease controls). International collaboration will contribute to study a large group of patients, which will be important in order to reach the project's goals. The results from the project are expected to increase current knowledge on the mechanisms of neuropathic pain, opening up new opportunities for innovative and improved treatments.

Dissemination of results will be organized in close collaboration with patient representatives, and will be done regularly throughout the course of the project. The will focus both on internal dissemination to the participating hospitals, and external dissemination through participation in conferences, submissions to scientific journals and by publishing patient-friendly information booklets and proactively informing media outlets and patient organizations.

Being tested
Nerve conduction Studies
Keywords
reliability, validity
Medical subject headings
Neuralgia, Genetic Predisposition to Disease, Polyneuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nerve conduction StudiesGenetic

    Also called Genetical analysis

    Patients will be genotyped for comparison of patients With and without pain, With different clinical subgroups as mentioned.

Study groups in NCT03862365
Study groupRoleWhat they receive
Polyneuropathy with painClinical and diagnostic test evaluation for the establishment of polyneuropathy with pain.
Receives: Genetic: Nerve conduction Studies
Polyneuropathy without painClinical and diagnostic test evaluation for the establishment of polyneuropathy without pain.
Receives: Genetic: Nerve conduction Studies
Diabetic polyneuropathy with painClinical and diagnostic test evaluation for the establishment of diabetic polyneuropathy with pain.
Receives: Genetic: Nerve conduction Studies
Diabetic polyneuropathy without painClinical and diagnostic test evaluation for the establishment of diabetic polyneuropathy without pain.
Receives: Genetic: Nerve conduction Studies
Carpal tunnel syndrome with painClinical and diagnostic test evaluation for the establishment of carpal tunnel syndrome with pain.
Receives: Genetic: Nerve conduction Studies
Carpal tunnel syndrome without painClinical and diagnostic test evaluation for the establishment of carpal tunnel syndrome without pain.
Receives: Genetic: Nerve conduction Studies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Genetic variants associated with neuropathic pain.

    Relevant genotypes will be found using genome-wide association study (GWAS) methodology, ie. with no assumptions regarding which genetic variants that may be relevant (no hypotheses regarding specific variants). This is going to be conducted by using array genotyping (SNPs) in order to identify genetic variants that might be associated with neuropathic pain. Genetic variants will be defined and named according to standard practice, without any room for local or study specific adaptations.

    Measured: Baseline

  2. Phenotype; neuropathic pain yes/no

    Patients will be divided in two groups; neuropathy With pain (= neuropathic pain) and neuropathy without pain. For definition of neuropathic pain, the Neupsig guidelines (Finnerup et al, Pain 2016) will be used.It is estimated that about 600 patients will be included yearly for this purpose

    Measured: Baseline

  3. Phenotype; subgroup analysis of patients with neuropathic pain based on grading of pain

    Patients with neuropathic pain will be further subdivided in groups based on pain reports. Pain will be graded using validated questionnaires. The "Brief Pain Inventory-BPI" (Cleeland et al, 1994) questionnaire will be used as primary resource for pain grading, on a scale from 0 to 10 (0: no pain, 1-3: mild pain, 4-10: strong pain).

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2019
  2. Study start1 Aug 2018
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Case-control
Time perspective
Cross-sectional
Enrolment
5,000 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT03862365
Sponsor's protocol ID
2017/1593
Acronym
GeNeup
Status last verified
Nov 2023
First submitted
11 Dec 2018
Last updated
7 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Spildrejorde M, Dunker O, Allen SM, Kvaloy MB, Uglem M, Hjelland I, Loseth S, Bennett DL, Zwart JA, Winsvold BS, Gervin K, Selmer KK, Nilsen KB. Genome-wide association study of neuropathic pain. Pain. 2026 Mar 1;167(3):731-738. doi: 10.1097/j.pain.0000000000003848. Epub 2025 Nov 21.

    PubMed 41359007

Questions about this trial

What is this clinical trial studying?

An observational study of Neuropathic Pain and Genetic Predisposition, run by Oslo University Hospital at 5 sites in Norway.

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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Norway. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kristian B. Nilsen, M.D (+4791372241, uxnikq@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Genetic variants associated with neuropathic pain. (time frame: Baseline). The study lists 3 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 NCT03862365, 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 7 Nov 2023.

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