Ignite Creation Date:
2024-05-06 @ 7:57 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02637700
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2015-12-16
Brief Title:
Intravenous Immunoglobulin Therapy for Small Fiber Neuropathy
Sponsor:
Academisch Ziekenhuis Maastricht
Organization:
Academisch Ziekenhuis Maastricht
Study Overview
Official Title:
Intravenous Immunoglobulin Therapy for Small Fiber Neuropathy a Randomized Double-blind Placebo-controlled Study on Efficacy and Safety
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IVIg-SFN
Brief Summary:
Small fiber neuropathy SFN is the most common cause of neuropathic pain in peripheral neuropathies with a prevalence of at least 53100000 Patients with SFN may have excruciating pain and current anti-neuropathic and other pain drugs do not relief pain substantially
Several studies suggested an immunological basis in SFN and case studies have reported efficacy of treatment with intravenous immunoglobulin IVIg in patients with SFN It is therefore conceivable that immunological mechanisms play a role in idiopathic SFN I-SFN However to date no randomized controlled study with IVIg in patients with SFN has been performed The aim of the current study is to investigate the efficacy and safety of IVIg in patients with I-SFN in a randomized double-blind placebo-controlled study
The objective of the study is to evaluate the efficacy of IVIg treatment 4 courses of treatment 3 weeks apart compared to placebo on pain alleviation
Several studies suggested an immunological basis in SFN and case studies have reported efficacy of treatment with intravenous immunoglobulin IVIg in patients with SFN It is therefore conceivable that immunological mechanisms play a role in idiopathic SFN I-SFN However to date no randomized controlled study with IVIg in patients with SFN has been performed The aim of the current study is to investigate the efficacy and safety of IVIg in patients with I-SFN in a randomized double-blind placebo-controlled study
The objective of the study is to evaluate the efficacy of IVIg treatment 4 courses of treatment 3 weeks apart compared to placebo on pain alleviation
Detailed Description:
Small nerve fiber neuropathy SFN is a disorder of thinly myelinated and unmyelinated nerve fibers recently recognized as a distinct clinical syndrome with a minimum incidence of 12 per 100000 and a minimum prevalence of 53 per 100000 The clinical picture is typically dominated by neuropathic pain often with a burning quality and autonomic symptoms The diagnosis of SFN is usually made on the basis of the clinical picture no involvement of large nerve fibers at neurological examination and normal nerve conduction studies NCS and is confirmed by demonstration of reduced intra-epidermal nerve fiber density IENFD or abnormal quantitative sensory testing QST Despite intensive search for underlying causes such as diabetes mellitus impaired glucose tolerance Fabrys disease hereditary disorders celiac disease sarcoidosis HIV and other systemic illnesses which may be potentially treatable the proportion of patients with idiopathic SFN I-SFN remains substantial ranging in different series from 24 up to 93 It is conceivable that immunological mechanisms play a role in patients with I-SFN since several immune-mediated diseases such as sarcoidosis Sjogrens disease and systemic lupus erythematosis may cause SFN Auto-antibodies have also been reported in patients with SFN Moreover inflammatory changes in nerves have been found Elevated pro-inflammatory cytokines have been suggested to be involved in the pathophysiology of pain in SFN
In other immune-mediated neuropathies such as chronic inflammatory demyelinating polyneuropathy treatment with intravenous immunoglobulin IVIg has proven to be efficacious Moreover some case studies in patients with SFN and chronic pain have also reported effect of immunomodulating therapy Pain reduction with IVIg treatment has also been summarized recently
Intravenous infusion of high doses of pooled immunoglobulin G IgG molecules from thousands of donors IVIg therapy represents an efficient anti-inflammatory treatment for many autoimmune diseases Paradoxically IgG can exert both pro- and anti-inflammatory activities depending upon its concentration When administered in high concentrations IVIg has anti-inflammatory properties How this anti-inflammatory effect is mediated has not yet been fully elucidated Several mutually nonexclusive mechanisms have been proposed including modulation of the expression and function of the Fc fragment of IgG to IgG-specific receptors interference with activation of the complement cascade and the cytokine network neutralization of autoantibodies and regulation of cell proliferation However the exact mechanism of IVIg in the treatment of inflammatory neuropathies has not been elucidated
Side effects of IVIg treatment are usually transient chills headache dizziness fever vomiting nausea arthralgia low blood pressure and moderate low back pain may occur occasionally
Sudden fall in blood pressure and anaphylactic shock are rare More severe side effect are extremely rare reversible aseptic meningitis transient cutaneous reactions reversible haemolytic reactions haemolytic anemia and thromboembolic events
SFN is considered the most common cause of neuropathic pain in peripheral neuropathies Patients with SFN have reported having excruciating pain since current anti-neuropathic and other pain drugs do not relief pain substantially SFN interferes with daily functioning and may lead to a decrement in quality of life expectations Therefore a better treatment is warranted The aim of the current pilot study is to investigate the efficacy and safety of IVIg in patients with I-SFN in a randomized double-blind placebo-controlled study
In other immune-mediated neuropathies such as chronic inflammatory demyelinating polyneuropathy treatment with intravenous immunoglobulin IVIg has proven to be efficacious Moreover some case studies in patients with SFN and chronic pain have also reported effect of immunomodulating therapy Pain reduction with IVIg treatment has also been summarized recently
Intravenous infusion of high doses of pooled immunoglobulin G IgG molecules from thousands of donors IVIg therapy represents an efficient anti-inflammatory treatment for many autoimmune diseases Paradoxically IgG can exert both pro- and anti-inflammatory activities depending upon its concentration When administered in high concentrations IVIg has anti-inflammatory properties How this anti-inflammatory effect is mediated has not yet been fully elucidated Several mutually nonexclusive mechanisms have been proposed including modulation of the expression and function of the Fc fragment of IgG to IgG-specific receptors interference with activation of the complement cascade and the cytokine network neutralization of autoantibodies and regulation of cell proliferation However the exact mechanism of IVIg in the treatment of inflammatory neuropathies has not been elucidated
Side effects of IVIg treatment are usually transient chills headache dizziness fever vomiting nausea arthralgia low blood pressure and moderate low back pain may occur occasionally
Sudden fall in blood pressure and anaphylactic shock are rare More severe side effect are extremely rare reversible aseptic meningitis transient cutaneous reactions reversible haemolytic reactions haemolytic anemia and thromboembolic events
SFN is considered the most common cause of neuropathic pain in peripheral neuropathies Patients with SFN have reported having excruciating pain since current anti-neuropathic and other pain drugs do not relief pain substantially SFN interferes with daily functioning and may lead to a decrement in quality of life expectations Therefore a better treatment is warranted The aim of the current pilot study is to investigate the efficacy and safety of IVIg in patients with I-SFN in a randomized double-blind placebo-controlled study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-002624-31 | EUDRACT_NUMBER | None | None |