A Phase 4 interventional study of 10% intravenous immunoglobulin (IVIg) and 0.9% sodium chloride in Peripheral Neuropathy, Diabetes Mellitus and Chronic Inflammatory Demyelinating Polyneuropathy, sponsored by University of Toronto. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-11.
Sponsored by University of Toronto · Phase 4, Interventional, and Treatment
The purpose of this study is to determine whether intravenous immunoglobulin (IVIg) is an effective intervention for patients with diabetes, peripheral neuropathy, and demyelination on nerve conduction studies. All patients will receive both IVIg and placebo for 3 months each, with a 3 month washout period in between.
There is a knowledge gap with regards to the appropriate method of detecting and treating chronic inflammatory demyelinating polyneuropathy (CIDP), in patients with co-existent diabetes. In this pilot study the investigators plan to examine the overlap between diabetic polyneuropathy and CIDP by treating patients with diabetes and demyelinating abnormalities using IVIg. The investigators will enroll diabetes patients with a broad spectrum of demyelinating abnormalities.
The proposed trial will be an explanatory, blinded, single-centre, superiority, randomized controlled cross-over trial. Each patient will receive 3 months of 10% intravenous immunoglobulin and 3 months of placebo (0.9% sodium chloride in water) with a 3-month washout period. The primary outcome measure is the mean change in ONLS (Overall Neuropathy Limitation Scale), a measure of disability in polyneuropathy; however secondary outcome measures will consider impairments and quality of life.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's planned enrollment of 25 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →University of Toronto is the lead sponsor of 397 studies on the registry; 59 are open to participants now.
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Clinical evidence of polyneuropathy and NCS shows 2 separate motor nerves (median, ulnar, tibial, or peroneal) which meet criteria for demyelination, defined as follows:
Exclusion Criteria:
1. 10% caprylate-chromatography purified intravenous immunoglobulin (IVIg) Initial dose: 1.0gm/kg/day for 2 days (maximum 80gm/day). Maintenance dose (monthly x3): 1.0mg/kg/day for 1 day (maximum 80gm/day) 2. Washout period 3. 0.9% sodium chloride in water - equal volume to IVIg - Monthly x4
Drug: 10% intravenous immunoglobulin (IVIg) · Drug: 0.9% sodium chloride
1. 0.9% sodium chloride in water - equal volume to IVIg - Monthly x4 2. Washout period 3. 10% caprylate-chromatography purified intravenous immunoglobulin (IVIg) Initial dose: 1.0gm/kg/day for 2 days (maximum 80gm/day). Maintenance dose (monthly x3): 1.0mg/kg/day for 1 day (maximum 80gm/day)
Drug: 10% intravenous immunoglobulin (IVIg) · Drug: 0.9% sodium chloride
Also known as: Gamunex
Also known as: Normal Saline
Change in Overall Neuropathy Limitations Score (ONLS) after 3 months
ONLS score will be measured before and after 3 months of IVIg / placebo
Time frame: Baseline and 3 months
Change in Rasch-Built Overall Disability Scale (R-ODS) after 3 months
R-ODS score will be measured before and after 3 months of IVIg / placebo
Time frame: Baseline and 3 months
Change in Nerve Conduction Studies (NCS) after 3 months
Changes in NCS parameters will be compared before and after 3 months of IVIg / placebo
Time frame: Baseline and 3 months
Change in Medical Research Council (MRC) Sum Score after 3 months
MRC sum score will be compared before and after 3 months of IVIg / placebo
Time frame: Baseline and 3 months
Change in Grip Strength after 3 months
Grip strength (using Martin vigorimeter) will be compared before and after 3 months of IVIg / placebo
Time frame: Baseline and 3 months
Change in Short Form 36 (SF-36) Quality of Life after 3 months
SF-36 will be compared before and after 3 months of IVIg / placebo
Time frame: Baseline and 3 months
Adverse Events
Number of adverse events and serious adverse events within 30 days of IVIg administration
Time frame: 30 days
This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Peripheral Nervous System Diseases→
University of Toronto