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IVIg for Demyelination in Diabetes Mellitus (IDIDM)

Primary Purpose

Peripheral Neuropathy, Diabetes Mellitus, Chronic Inflammatory Demyelinating Polyneuropathy

Status

Unknown status

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

10% intravenous immunoglobulin (IVIg)

0.9% sodium chloride

About this trial

This is an interventional treatment trial for Peripheral Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
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.
Clinical suspicion of possible demyelinating polyneuropathy (CIDP).

Exclusion Criteria:

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.

Sites / Locations

Toronto General Hospital / Toronto Western HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

IVIg--Washout--0.9% NaCl (CROSSOVER)

0.9% NaCl--Washout--IVIg (CROSSOVER)

Arm Description

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) Washout period 0.9% sodium chloride in water - equal volume to IVIg - Monthly x4

0.9% sodium chloride in water - equal volume to IVIg - Monthly x4 Washout period 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)

Outcomes

Primary Outcome Measures

Change in Overall Neuropathy Limitations Score (ONLS) after 3 months

ONLS score will be measured before and after 3 months of IVIg / placebo

Secondary Outcome Measures

Change in Rasch-Built Overall Disability Scale (R-ODS) after 3 months

R-ODS score will be measured before and after 3 months of IVIg / placebo

Change in Nerve Conduction Studies (NCS) after 3 months

Changes in NCS parameters will be compared before and after 3 months of IVIg / placebo

Change in Medical Research Council (MRC) Sum Score after 3 months

MRC sum score will be compared before and after 3 months of IVIg / placebo

Change in Grip Strength after 3 months

Grip strength (using Martin vigorimeter) will be compared before and after 3 months of IVIg / placebo

Change in Short Form 36 (SF-36) Quality of Life after 3 months

SF-36 will be compared before and after 3 months of IVIg / placebo

Adverse Events

Number of adverse events and serious adverse events within 30 days of IVIg administration

Full Information

NCT ID

NCT02372149

First Posted

February 12, 2015

Last Updated

November 10, 2016

Sponsor

University of Toronto

Collaborators

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT02372149

Brief Title

IVIg for Demyelination in Diabetes Mellitus

Acronym

IDIDM

Official Title

Treatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2015 (undefined)

Primary Completion Date

February 2018 (Anticipated)

Study Completion Date

February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Toronto

Collaborators

University Health Network, Toronto

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Neuropathy, Diabetes Mellitus, Chronic Inflammatory Demyelinating Polyneuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IVIg--Washout--0.9% NaCl (CROSSOVER)

Arm Type

Experimental

Arm Description

Arm Title

0.9% NaCl--Washout--IVIg (CROSSOVER)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

10% intravenous immunoglobulin (IVIg)

Other Intervention Name(s)

Gamunex

Intervention Type

Drug

Intervention Name(s)

0.9% sodium chloride

Other Intervention Name(s)

Normal Saline

Primary Outcome Measure Information:

Title

Change in Overall Neuropathy Limitations Score (ONLS) after 3 months

Description

ONLS score will be measured before and after 3 months of IVIg / placebo

Time Frame

Baseline and 3 months

Secondary Outcome Measure Information:

Title

Change in Rasch-Built Overall Disability Scale (R-ODS) after 3 months

Description

R-ODS score will be measured before and after 3 months of IVIg / placebo

Time Frame

Baseline and 3 months

Title

Change in Nerve Conduction Studies (NCS) after 3 months

Description

Changes in NCS parameters will be compared before and after 3 months of IVIg / placebo

Time Frame

Baseline and 3 months

Title

Change in Medical Research Council (MRC) Sum Score after 3 months

Description

MRC sum score will be compared before and after 3 months of IVIg / placebo

Time Frame

Baseline and 3 months

Title

Change in Grip Strength after 3 months

Description

Grip strength (using Martin vigorimeter) will be compared before and after 3 months of IVIg / placebo

Time Frame

Baseline and 3 months

Title

Change in Short Form 36 (SF-36) Quality of Life after 3 months

Description

SF-36 will be compared before and after 3 months of IVIg / placebo

Time Frame

Baseline and 3 months

Title

Adverse Events

Description

Number of adverse events and serious adverse events within 30 days of IVIg administration

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eduardo Ng, MD

Phone

416-340-4184

eduardo.ng@uhn.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ari Breiner, MD, FRCPC

Organizational Affiliation

University of Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Toronto General Hospital / Toronto Western Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eduardo Ng, MD

Phone

416-340-4184

eduardo.ng@uhn.ca

12. IPD Sharing Statement

Learn more about this trial

IVIg for Demyelination in Diabetes Mellitus

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