Probing the Role of Sodium Channels in Painful Neuropathies

NCT ID: NCT02243475

Last Updated: 2014-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30

Brief 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.

Conditions

Painful Peripheral Neuropathy; Painless Peripheral Neuropathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

University of Manchester

OTHER

Sponsor Role: collaborator

Deutsche Diabetes Gesellschaft

OTHER

Sponsor Role: collaborator

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role: collaborator

Ospedale San Raffaele

OTHER

Sponsor Role: collaborator

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Lauria, MD

Role: STUDY_CHAIR

FINCB

References

Ziegler D, Strom A, Bonhof GJ, Kannenberg JM, Heier M, Rathmann W, Peters A, Meisinger C, Roden M, Thorand B, Herder C. Deficits in systemic biomarkers of neuroinflammation and growth factors promoting nerve regeneration in patients with type 2 diabetes and polyneuropathy. BMJ Open Diabetes Res Care. 2019 Nov 27;7(1):e000752. doi: 10.1136/bmjdrc-2019-000752. eCollection 2019.

Reference Type: DERIVED

PMID: 31803481 (View on PubMed)

Puttgen S, Bonhof GJ, Strom A, Mussig K, Szendroedi J, Roden M, Ziegler D. Augmented Corneal Nerve Fiber Branching in Painful Compared With Painless Diabetic Neuropathy. J Clin Endocrinol Metab. 2019 Dec 1;104(12):6220-6228. doi: 10.1210/jc.2019-01072.

Reference Type: DERIVED

PMID: 31390004 (View on PubMed)

Other Identifiers

PROPANE STUDY

Identifier Type: -

Identifier Source: org_study_id