Probing the Role of Sodium Channels in Painful Neuropathies

Painful Peripheral Neuropathy Clinical Trial

Official title:

Probing the Role of Sodium Channels in Painful Neuropathies: Observational Study

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02243475
• Other study ID #: PROPANE STUDY
• Status: Unknown status
• Phase: N/A
• First received: September 12, 2014
• Last updated: September 17, 2014
• Start date: September 2014

Study information

• Verified date: September 2014
• Source: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Neuropathic pain is a frequent feature of peripheral neuropathy causing a significant impact on patients' quality of life and health care costs. Not all individuals with neuropathy develop pain and it is not possible to predict who is more or less susceptible among those with similar risk exposure. Current inability to identify high-risk individuals hinders development and application of therapies to counteract neuropathic pain and to address targeted prevention strategies. Recently, the investigators Consortium has identified novel pathogenic mutations in genes encoding for two sodium channels (Nav1.7 and Nav1.8) known to play a critical role in the generation and conduction of action potentials in nociceptors and their terminal axons. This study was undertaken in a carefully selected group of patients with painful neuropathy using a candidate gene approach and directly revealed targets for new therapeutic strategies. This discover widened the spectrum of sodium channel-related pain disorders including conditions more common in the general population than those known so far. PROPANE STUDY, starting from the hypothesis of a common origin of neuropathic pain in a cohort of patients with predominantly small fibre neuropathy, aims to develop this original idea in a larger and well characterized study population, to provide evidence for the reliable stratification of patients at high risk and potential new treatments tailored on patients' clinical features, in order to improve their quality of life.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 1500
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of sensory neuropathy, including pure small fibre neuropathy (SFN), based on established clinical, nerve conduction study (NCS) and skin biopsy findings (Tesfaye et al. Diab Care 2010) caused by

1. type 1 or type 2 diabetes (World Health Organization criteria) with stable metabolic control for >6 months (haemoglobin A1C <9%); or

2. idiopathic aetiology after ruling out all known causes of neuropathy including vitamin deficiencies, malignancies, toxic, drugs

Exclusion Criteria:

• any other cause of neuropathy

Related Conditions & MeSH terms

• Pain
• Painful Peripheral Neuropathy
• Painless Peripheral Neuropathy
• Peripheral Nervous System Diseases

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta	Centre National de la Recherche Scientifique, France, Deutsche Diabetes Gesellschaft, Maastricht University, Ospedale San Raffaele, University of Manchester, Yale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with novel mutations in the genes encoding for Nav1.7, Nav1.8, Nav1.9, Nav1.6, and Nav1.3 sodium channels		2 years