Recruiting

IVIg

Sponsor:

University of Toronto

Code:

NCT02372149

Conditions

Peripheral Neuropathy

Diabetes Mellitus

Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

10% intravenous immunoglobulin (IVIg)

0.9% sodium chloride

Study Details

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.

Conditions

Peripheral Neuropathy

Diabetes Mellitus

Chronic Inflammatory Demyelinating Polyneuropathy

Study ID

NCT02372149

Start date

Feb, 2015

Status verified date

Nov, 2016

Completion date

Feb, 2018

Anticipated

Primary completion date

Feb, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

experimental: 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)

Interventions

10% intravenous immunoglobulin (IVIg)

0.9% sodium chloride

Primary outcome measure

  • Change in Overall Neuropathy Limitations Score (ONLS) after 3 months [ Time Frame: Baseline and 3 months ]

Central Contacts and Locations

Central contacts

Locations

Toronto General Hospital / Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

More Information

Sponsor

University of Toronto

Last update posted

Nov 11, 2016

Last verified

Nov, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2016-11-11.