Intravenous Immunoglobulin (IVIG) for Resistant Neuropathic Pain

NCT00850005 | Unknown Phase 2

• 1 other identifier: 200434
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 1.Reduction in neuroinflammation (NI) markers will co-vary with clinical indicators of pain relief
2. 2.Patients with higher levels of markers of NI will be more likely to respond to IVIG

Conditions

Neuropathic Pain

Keywords

neuropathic pain; resistant; neuroinflammation; neuroinflammatory markers; Neuropathic pain that has not responded to standard therapy

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure will consist of change in mean daily pain diary score from baseline to each week post-treatment

  Performed at screening, before the initial infusion, 2 weeks and 4 weeks post treatment

Secondary Outcomes (1)

• Measurement of neuroinflammation (NI) markers (IL-1β, IL-6, IL-8, TNF-α, MMP-9, TIMP-1)

  Performed at screening, before the initial infusion, 2 weeks and 4 weeks post treatment

Study Arms (2)

IVIG

EXPERIMENTAL

Active treatment will be intravenous immunoglobulin G (Gamunex, immune globulin intravenous \[human\], 10%), at a dose of 2 g/kg divided over five days (0.4 g/kg/day).

Biological: Intravenous immunoglobulin

Placebo

PLACEBO COMPARATOR

The placebo treatment will be intravenous normal saline and will be infused in a similar manner.

Biological: Normal Saline

Interventions

Intravenous immunoglobulin BIOLOGICAL

2 g/kg divided over five days

IVIG

Normal Saline BIOLOGICAL

Same volume as experimental arm

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years; Clinical diagnosis of treatment-resistant neuropathic pain;
• Score of 4/10 or greater on the DN4 NeP screening questionnaire;
• Bedside examination confirming symptoms of neuropathic pain;
• Moderate to severe pain;
• Completed adequate analgesic trials according to neuropathic pain clinical practice guidelines;
• provides informed consent

You may not qualify if:

• Pregnant or lactating women;
• Clinical diagnosis of phantom limb pain;
• History of psychosis;
• current, substance dependency disorder;
• presence of clinically significant cardiac or pulmonary disorder that would compromise participants' safety;
• severe pain disorder other than the chronic NeP under study;
• Abnormalities above 1.5 times upper range of normal on screening CBC, blood chemistry;
• Serum IgA less than \<0.05 g/L

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, Canada

RECRUITING

MeSH Terms

Conditions

Neuralgia; Neuroinflammatory Diseases

Interventions

Immunoglobulins, Intravenous; Saline Solution

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Inflammation; Pathologic Processes

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Alexander J Clark, MD, FRCPC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander J Clark, MD, FRCPC

CONTACT

403 943 9917; john.clark@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 24, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 24, 2009

Record last verified: 2009-02

Locations

CA (1)