IVIg for Demyelination in Diabetes Mellitus
IDIDM
Treatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot Study
1 other identifier
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2015
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 12, 2015
CompletedFirst Posted
Study publicly available on registry
February 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedNovember 11, 2016
November 1, 2016
3 years
February 12, 2015
November 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Overall Neuropathy Limitations Score (ONLS) after 3 months
ONLS score will be measured before and after 3 months of IVIg / placebo
Baseline and 3 months
Secondary Outcomes (6)
Change in Rasch-Built Overall Disability Scale (R-ODS) after 3 months
Baseline and 3 months
Change in Nerve Conduction Studies (NCS) after 3 months
Baseline and 3 months
Change in Medical Research Council (MRC) Sum Score after 3 months
Baseline and 3 months
Change in Grip Strength after 3 months
Baseline and 3 months
Change in Short Form 36 (SF-36) Quality of Life after 3 months
Baseline and 3 months
- +1 more secondary outcomes
Study Arms (2)
IVIg--Washout--0.9% NaCl (CROSSOVER)
EXPERIMENTAL1. 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
0.9% NaCl--Washout--IVIg (CROSSOVER)
EXPERIMENTAL1. 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)
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥18 years.
- Diabetes, as per American Diabetes Association Criteria.
- Clinical evidence of polyneuropathy and NCS shows 2 separate motor nerves (median, ulnar, tibial, or peroneal) which meet criteria for demyelination, defined as follows:
- Conduction velocity \<90% lower limit of normal (LLN), distal latency \>110% upper limit of normal (ULN), or minimal F-wave latency \>110% ULN
- The changes are not exclusively due to median neuropathy at the wrist, ulnar neuropathy at the elbow, or peroneal neuropathy at the fibular head.
- Clinical suspicion of possible demyelinating polyneuropathy (CIDP).
You may not qualify if:
- Pregnant patients, or those of childbearing potential not using contraception.
- Patients \<18 years of age.
- 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.
- 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.
- 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.
- Presence of concomitant neurological illness, which may confound evaluation.
- Fails or unable to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Torontolead
- University Health Network, Torontocollaborator
Study Sites (1)
Toronto General Hospital / Toronto Western Hospital
Toronto, Ontario, M5G 2C4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ari Breiner, MD, FRCPC
University of Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine (Neurology)
Study Record Dates
First Submitted
February 12, 2015
First Posted
February 26, 2015
Study Start
February 1, 2015
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
November 11, 2016
Record last verified: 2016-11