drugset / Trial / NCT00850005

Intravenous Immunoglobulin (IVIG) for Resistant Neuropathic Pain

NCT00850005

Phase 2 Unknown 12 enrolled University of Calgary
RandomizedCrossoverTriple-blindTreatment

Summary

This project addresses a vexing problem that has alluded the best efforts of the medical/scientific community: treatment of resistant neuropathic pain. Neuropathic pain is common and includes conditions such as diabetic neuropathy, post herpetic neuralgia and post stroke pain and is believed to affect at least 3% of adults. Surveys of patients with neuropathic pain indicate that 60% do not receive adequate relief with current treatment. Results from recent laboratory and human studies reveal a new approach to treatment. This approach is based on the findings that neuroinflammation appears to be involved in development and maintenance of neuropathic pain. This study explores the effects of an immune-modulating blood-derived product, intravenous immunoglobulin (IVIG), in treating neuropathic pain. IVIG is thought to reduce neuroinflammation contributing to neuropathic pain. If successful, the study will provide important insights into pain mechanisms and a better understanding of how IVIG relieves neuropathic pain. Hypotheses: 1. Reduction in neuroinflammation (NI) markers will co-vary with clinical indicators of pain relief 2. Patients with higher levels of markers of NI will be more likely to respond to IVIG

Timeline

Start
2009-02
Primary completion
2010-07
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 2 g/kg Intravenous

Indications