Intravenous Immunoglobulin (IVIG) for Resistant Neuropathic Pain

NCT ID: NCT00850005

Last Updated: 2009-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-12-31

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. 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

Detailed Description

This study will employ a randomized double blind cross-over design. A total of 12 subjects will be recruited for the study. Once each subject has satisfied the inclusion and exclusion criteria and provided informed consent, the subject will be randomized to either the IVIG or placebo treatment groups, using a pre-determined randomization list generated by the research office at the University of Calgary. Complete responders will begin a monitoring phase, partial and non-responders will return for a second cycle in one month. Complete responders, with prolonged relief, will cross-over to the alternative treatment when their pain returns if this occurs within 6 months of the infusion.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

IVIG

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).

Group Type: EXPERIMENTAL

Intravenous immunoglobulin

Intervention Type: BIOLOGICAL

2 g/kg divided over five days

Placebo

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

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: BIOLOGICAL

Same volume as experimental arm

Interventions

Intravenous immunoglobulin

2 g/kg divided over five days

Intervention Type: BIOLOGICAL

Normal Saline

Same volume as experimental arm

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

University of Calgary

Principal Investigators

Alexander J Clark, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Foothills Medical Centre

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Alexander J Clark, MD, FRCPC

Role: CONTACT

john.clark@albertahealthservices.ca

403 943 9917

Facility Contacts

Alexander J Clark, MD

Role: primary

403 943 9917

Patricia Muehler

Role: backup

403 943 9917

Other Identifiers

200434

Identifier Type: -

Identifier Source: org_study_id