IVIg for Demyelination in Diabetes Mellitus
Information source: University of Toronto
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peripheral Neuropathy; Diabetes Mellitus; Chronic Inflammatory Demyelinating Polyneuropathy
Intervention: 10% intravenous immunoglobulin (IVIg) (Drug); 0.9% sodium chloride (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Toronto Official(s) and/or principal investigator(s): Ari Breiner, MD, FRCPC, Principal Investigator, Affiliation: University of Toronto
Overall contact: Eduardo Ng, MD, Phone: 416-340-4184, Email: eduardo.ng@uhn.ca
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.
Clinical Details
Official title: Treatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot Study
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in Overall Neuropathy Limitations Score (ONLS) after 3 months
Secondary outcome: Change in Rasch-Built Overall Disability Scale (R-ODS) after 3 monthsChange in Nerve Conduction Studies (NCS) after 3 months Change in Medical Research Council (MRC) Sum Score after 3 months Change in Grip Strength after 3 months Change in Short Form 36 (SF-36) Quality of Life after 3 months Adverse Events
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Eduardo Ng, MD, Phone: 416-340-4184, Email: eduardo.ng@uhn.ca
Toronto General Hospital / Toronto Western Hospital, Toronto, Ontario M5G 2C4, Canada; Recruiting Eduardo Ng, MD, Phone: 416-340-4184, Email: eduardo.ng@uhn.ca
Additional Information
Starting date: February 2015
Last updated: February 19, 2015
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