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Probing the role of sodium channels in painful neuropathies (PROPANE Study)

Probing the role of sodium channels in painful neuropathies (PROPANE Study) - PROPANE Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43862
Enrollment
500
Registered
2011-06-10
Start date
2012-03-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

painful neuropathy Peripheral neuropathy

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subjects with Painful PN must meet all of the following inclusion criteria to be eligible for participation: a. Fulfillment of the international diagnostic criteria for snall fiber neuropathy, for painful diabetic neuropathy or for chemotherapy induced PN by taxane in breast, ovarian or prostate cancer and oxaliplatin in colon cancer. Patients with CIPN have completed their chemotherapy treatment. b. Maximal pain VAS scores must be at least 40 (range: 0 - 100) (without neuropathic pain medication; in case of use of neuropathic pain medication, the VAS-score in the past without medication to the best of patients knowledge will be used) c. Age 18 years or older. d. Each subject will receive an information leaflet and an informed consent form. Subjects must give informed consent by signing and dating an informed consent form prior to study entry. Subjects must be willing to complete all study-related activities and examination required by the protocol. e. For the control groups, maximal pain VAS scores must be less than 40, preferably

Exclusion criteria

Exclusion criteria: Concomitant diseases that might interfere with the interpretations of the results.

Design outcomes

Primary

MeasureTime frame
The presence of mutations in SCN3A, SCN6A, SCN9a, SCN10a, SCN11a genes, in addition, in those patients with small fiber neuropathy or idiopathic neuropathy without mutations in the sodium channels and high chance of a genetic origin (age at onset

Secondary

MeasureTime frame
na.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)