← Back to Search

Immunomodulator

IVIG for Neuropathic Pain

Phase 2
Waitlist Available
Led By Alexander J Clark, MD, FRCPC
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up performed at screening, before the initial infusion, 2 weeks and 4 weeks post treatment
Awards & highlights

Study 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: 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

Eligible Conditions
  • Neuropathic Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~performed at screening, before the initial infusion, 2 weeks and 4 weeks post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and performed at screening, before the initial infusion, 2 weeks and 4 weeks post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The measure will consist of change in mean daily pain diary score from baseline to each week post-treatment
Secondary outcome measures
Measurement of neuroinflammation (NI) markers (IL-1β, IL-6, IL-8, TNF-α, MMP-9, TIMP-1)

Side effects data

From 2022 Phase 2 trial • 20 Patients • NCT03401073
80%
Infusion reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intravenous Immunoglobulin
0.9% Sodium Chloride

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IVIGExperimental Treatment1 Intervention
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 II: PlaceboPlacebo Group1 Intervention
The placebo treatment will be intravenous normal saline and will be infused in a similar manner.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Human immunoglobulin G
FDA approved

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
791 Previous Clinical Trials
868,722 Total Patients Enrolled
2 Trials studying Neuropathic Pain
130 Patients Enrolled for Neuropathic Pain
Alexander J Clark, MD, FRCPCPrincipal InvestigatorUniversity of Calgary

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Apr 2025