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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
Sponsor:
Information provided by:
University of Calgary

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

Condition or disease Intervention/treatment Phase
Neuropathic Pain Biological: Intravenous immunoglobulin Biological: Normal Saline Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Alexander J Clark, MD, FRCPC 403 943 9917 john.clark@albertahealthservices.ca

Locations
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Canada, Alberta
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         
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Alexander J Clark, MD, FRCPC University of Calgary

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Responsible Party: Alexander J Clark MD FRCPC, University of Calgary
ClinicalTrials.gov Identifier: NCT00850005     History of Changes
Other Study ID Numbers: 200434
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: February 24, 2009
Last Verified: February 2009
Keywords provided by University of Calgary:
neuropathic pain
resistant
neuroinflammation
neuroinflammatory markers
Neuropathic pain that has not responded to standard therapy
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs