Status:

UNKNOWN

Probing the Role of Sodium Channels in Painful Neuropathies

Lead Sponsor:

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

Collaborating Sponsors:

Maastricht University

Yale University

Conditions:

Painful Peripheral Neuropathy

Painless Peripheral Neuropathy

Eligibility:

All Genders

18+ years

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...

Eligibility Criteria

Inclusion

  • 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
  • type 1 or type 2 diabetes (World Health Organization criteria) with stable metabolic control for \>6 months (haemoglobin A1C \<9%); or
  • idiopathic aetiology after ruling out all known causes of neuropathy including vitamin deficiencies, malignancies, toxic, drugs

Exclusion

  • any other cause of neuropathy

Key Trial Info

Start Date :

September 1 2014

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

1500 Patients enrolled

Trial Details

Trial ID

NCT02243475

Start Date

September 1 2014

Last Update

September 18 2014

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