IVIg for Demyelination in Diabetes Mellitus

Diabetes Mellitus Clinical Trial

— IDIDM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02372149
• Other study ID #: 14-8297-B
• Status: Recruiting
• Phase: Phase 4
• First received: February 12, 2015
• Last updated: November 10, 2016
• Start date: February 2015
• Est. completion date: February 2018

Study information

• Verified date: November 2016
• Source: University of Toronto
• Contact: Eduardo Ng, MD
• Phone: 416-340-4184
• Email: eduardo.ng[@]uhn.ca
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Inflammatory Demyelinating Polyneuropathy
• Demyelinating Diseases
• Diabetes Mellitus
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Polyneuropathies
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Drug:
• 10% intravenous immunoglobulin (IVIg)

• 0.9% sodium chloride

Locations

Country	Name	City	State
Canada	Toronto General Hospital / Toronto Western Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Baseline and 3 months	No
Secondary	Change in Nerve Conduction Studies (NCS) after 3 months	Changes in NCS parameters will be compared before and after 3 months of IVIg / placebo	Baseline and 3 months	No
Secondary	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	Baseline and 3 months	No
Secondary	Change in Grip Strength after 3 months	Grip strength (using Martin vigorimeter) will be compared before and after 3 months of IVIg / placebo	Baseline and 3 months	No
Secondary	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	Baseline and 3 months	No
Secondary	Adverse Events	Number of adverse events and serious adverse events within 30 days of IVIg administration	30 days	Yes