Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
25 participants
INTERVENTIONAL
2015-02-28
2018-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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IVIg--Washout--0.9% NaCl (CROSSOVER)
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
10% intravenous immunoglobulin (IVIg)
0.9% sodium chloride
0.9% NaCl--Washout--IVIg (CROSSOVER)
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)
10% intravenous immunoglobulin (IVIg)
0.9% sodium chloride
Interventions
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10% intravenous immunoglobulin (IVIg)
0.9% sodium chloride
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diabetes, as per American Diabetes Association Criteria.
3. Clinical evidence of polyneuropathy and NCS shows 2 separate motor nerves (median, ulnar, tibial, or peroneal) which meet criteria for demyelination, defined as follows:
1. Conduction velocity \<90% lower limit of normal (LLN), distal latency \>110% upper limit of normal (ULN), or minimal F-wave latency \>110% ULN
2. The changes are not exclusively due to median neuropathy at the wrist, ulnar neuropathy at the elbow, or peroneal neuropathy at the fibular head.
4. Clinical suspicion of possible demyelinating polyneuropathy (CIDP).
Exclusion Criteria
2. Patients \<18 years of age.
3. Presence of an alternative etiology of peripheral neuropathy, such as: hereditary neuropathies (Charcot Marie-Tooth disease); B-vitamin deficiency- or excess-related neuropathy; uremic neuropathy; neuropathy secondary to monoclonal gammopathy; history of cancer- or chemotherapy-related neuropathy; other toxin exposures; and alcoholic neuropathy.
4. Contraindication to IVIg, including: history of recurrent thrombosis, immunoglobulin A deficiency, or severe hypersensitivity reaction to IVIg in past, renal failure, recurrent deep venous thrombosis, pulmonary embolus, stroke, or myocardial infarction.
5. Presence of serious or unstable medical condition, which may preclude study completion or lead to inability to tolerate IVIg. This may include active heart failure, uncontrolled hypertension, or severe anemia, among other conditions.
6. Presence of concomitant neurological illness, which may confound evaluation.
7. Fails or unable to provide informed consent.
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
University of Toronto
OTHER
Responsible Party
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Ari Breiner, MD
Assistant Professor of Medicine (Neurology)
Principal Investigators
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Ari Breiner, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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Toronto General Hospital / Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Eduardo Ng, MD
Role: primary
Other Identifiers
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14-8297-B
Identifier Type: -
Identifier Source: org_study_id