Recruiting
Phase 2

IVIG

Sponsor:

University of Calgary

Code:

NCT00850005

Conditions

Neuropathic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intravenous immunoglobulin

Normal Saline

Study Details

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

Conditions

Neuropathic Pain

Study ID

NCT00850005

Start date

Feb, 2009

Status verified date

Feb, 2009

Completion date

Dec, 2010

Anticipated

Primary completion date

Jul, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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).

placebo comparator: Placebo

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

Interventions

Intravenous immunoglobulin

2 g/kg divided over five days

Normal Saline

Same volume as experimental arm

Primary outcome measure

  • The primary outcome measure will consist of change in mean daily pain diary score from baseline to each week post-treatment [ Time Frame: Performed at screening, before the initial infusion, 2 weeks and 4 weeks post treatment ]

Central Contacts and Locations

Central contacts

Alexander J Clark, MD, FRCPC

403 943 9917john.clark@albertahealthservices.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada

Contacts

Alexander J Clark, MD

403 943 9917

Patricia Muehler

403 943 9917

Principal Investigator:

Alexander J Clark, MD

More Information

Sponsor

University of Calgary

Last update posted

Feb 24, 2009

Last verified

Feb, 2009

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2009-02-24.