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Probing the Role of Sodium Channels in Painful Neuropathies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02243475
Recruitment Status : Unknown
Verified September 2014 by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta.
Recruitment status was:  Not yet recruiting
First Posted : September 18, 2014
Last Update Posted : September 18, 2014
Sponsor:
Collaborators:
Maastricht University
Yale University
University of Manchester
Deutsche Diabetes Gesellschaft
Centre National de la Recherche Scientifique, France
Ospedale San Raffaele
Information provided by (Responsible Party):
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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.

Condition or disease
Painful Peripheral Neuropathy Painless Peripheral Neuropathy

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Probing the Role of Sodium Channels in Painful Neuropathies: Observational Study
Study Start Date : September 2014
Estimated Primary Completion Date : September 2016



Primary Outcome Measures :
  1. Number of patients with novel mutations in the genes encoding for Nav1.7, Nav1.8, Nav1.9, Nav1.6, and Nav1.3 sodium channels [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
identification of novel mutations in the genes encoding for Nav1.7, Nav1.8, Nav1.9, Nav1.6, and Nav1.3 sodium channels


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
homogeneous cohorts of patients (age >18 years) with painful and painless diabetic or idiopathic sensory neuropathy
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243475


Sponsors and Collaborators
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Maastricht University
Yale University
University of Manchester
Deutsche Diabetes Gesellschaft
Centre National de la Recherche Scientifique, France
Ospedale San Raffaele
Investigators
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Study Chair: Giuseppe Lauria, MD FINCB
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
ClinicalTrials.gov Identifier: NCT02243475    
Other Study ID Numbers: PROPANE STUDY
First Posted: September 18, 2014    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Pain
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations