Intravenous Immunoglobulin (IVIG) for Resistant Neuropathic Pain
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|ClinicalTrials.gov Identifier: NCT00850005|
Recruitment Status : Unknown
Verified February 2009 by University of Calgary.
Recruitment status was: Recruiting
First Posted : February 24, 2009
Last Update Posted : February 24, 2009
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.
- Reduction in neuroinflammation (NI) markers will co-vary with clinical indicators of pain relief
- Patients with higher levels of markers of NI will be more likely to respond to IVIG
|Condition or disease||Intervention/treatment||Phase|
|Neuropathic Pain||Biological: Intravenous immunoglobulin Biological: Normal Saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||IVIG for Treatment of Resistant Neuropathic Pain: a Preliminary Study|
|Study Start Date :||February 2009|
|Estimated Primary Completion Date :||July 2010|
|Estimated Study Completion Date :||December 2010|
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
2 g/kg divided over five days
Placebo Comparator: Placebo
The placebo treatment will be intravenous normal saline and will be infused in a similar manner.
Biological: Normal Saline
Same volume as experimental arm
- 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 ]
- Measurement of neuroinflammation (NI) markers (IL-1β, IL-6, IL-8, TNF-α, MMP-9, TIMP-1) [ Time Frame: Performed at screening, before the initial infusion, 2 weeks and 4 weeks post treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850005
|Contact: Alexander J Clark, MD, FRCPC||403 943 firstname.lastname@example.org|
|Foothills Medical Centre||Recruiting|
|Calgary, Alberta, Canada|
|Contact: Alexander J Clark, MD 403 943 9917|
|Contact: Patricia Muehler 403 943 9917|
|Principal Investigator: Alexander J Clark, MD|
|Principal Investigator:||Alexander J Clark, MD, FRCPC||University of Calgary|