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Intravenous Immunoglobulin Therapy for Small Fiber Neuropathy

NCT02637700 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-07-05

No results posted yet for this study

Summary

Small fiber neuropathy (SFN) is the most common cause of neuropathic pain in peripheral neuropathies, with a prevalence of at least 53/100.000. 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.

Conditions

  • Small Fiber Neuropathy

Interventions

DRUG

Intravenous Immunoglobulin

Comparison between intravenous immunoglobulin and placebo (saline 0.9%).

DRUG

Placebo

Comparison between placebo (saline 0.9%) and intravenous immunoglobulin.

Sponsors & Collaborators

  • Academisch Ziekenhuis Maastricht

    lead OTHER

Principal Investigators

  • Catharina G Faber, MD, PhD · Academisch Ziekenhuis Maastricht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02637700 on ClinicalTrials.gov