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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 21 November 2016
Main ID:  NCT02372149
Date of registration: 12/02/2015
Prospective Registration: Yes
Primary sponsor: University of Toronto
Public title: IVIg for Demyelination in Diabetes Mellitus IDIDM
Scientific title: Treatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot Study
Date of first enrolment: February 2015
Target sample size: 25
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02372149
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Canada
Contacts
Name:     Eduardo Ng, MD
Address: 
Telephone: 416-340-4184
Email: eduardo.ng@uhn.ca
Affiliation: 
Name:     Eduardo Ng, MD
Address: 
Telephone: 416-340-4184
Email: eduardo.ng@uhn.ca
Affiliation: 
Name:     Ari Breiner, MD, FRCPC
Address: 
Telephone:
Email:
Affiliation:  University of Toronto
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age =18 years.

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:

1. Pregnant patients, or those of childbearing potential not using contraception.

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyneuropathy
Diabetes Mellitus
Peripheral Neuropathy
Intervention(s)
Drug: 0.9% sodium chloride
Drug: 10% intravenous immunoglobulin (IVIg)
Primary Outcome(s)
Change in Overall Neuropathy Limitations Score (ONLS) after 3 months [Time Frame: Baseline and 3 months]
Secondary Outcome(s)
Adverse Events [Time Frame: 30 days]
Change in Grip Strength after 3 months [Time Frame: Baseline and 3 months]
Change in Medical Research Council (MRC) Sum Score after 3 months [Time Frame: Baseline and 3 months]
Change in Nerve Conduction Studies (NCS) after 3 months [Time Frame: Baseline and 3 months]
Change in Rasch-Built Overall Disability Scale (R-ODS) after 3 months [Time Frame: Baseline and 3 months]
Change in Short Form 36 (SF-36) Quality of Life after 3 months [Time Frame: Baseline and 3 months]
Secondary ID(s)
14-8297-B
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University Health Network, Toronto
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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