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IVIg for Demyelination in Diabetes Mellitus (IDIDM)

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ClinicalTrials.gov Identifier: NCT02372149
Recruitment Status : Unknown
Verified November 2016 by Ari Breiner, MD, University of Toronto.
Recruitment status was:  Recruiting
First Posted : February 26, 2015
Last Update Posted : November 11, 2016
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Ari Breiner, MD, University of Toronto

Tracking Information
First Submitted Date  ICMJE February 12, 2015
First Posted Date  ICMJE February 26, 2015
Last Update Posted Date November 11, 2016
Study Start Date  ICMJE February 2015
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2015)
Change in Overall Neuropathy Limitations Score (ONLS) after 3 months [ Time Frame: Baseline and 3 months ]
ONLS score will be measured before and after 3 months of IVIg / placebo
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2015)
  • Change in Rasch-Built Overall Disability Scale (R-ODS) after 3 months [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 3 months ]
    MRC sum score will be compared before and after 3 months of IVIg / placebo
  • Change in Grip Strength after 3 months [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 3 months ]
    SF-36 will be compared before and after 3 months of IVIg / placebo
  • Adverse Events [ Time Frame: 30 days ]
    Number of adverse events and serious adverse events within 30 days of IVIg administration
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IVIg for Demyelination in Diabetes Mellitus
Official Title  ICMJE Treatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Peripheral Neuropathy
  • Diabetes Mellitus
  • Chronic Inflammatory Demyelinating Polyneuropathy
Intervention  ICMJE
  • Drug: 10% intravenous immunoglobulin (IVIg)
    Other Name: Gamunex
  • Drug: 0.9% sodium chloride
    Other Name: Normal Saline
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: 10% intravenous immunoglobulin (IVIg)
    • Drug: 0.9% sodium chloride
  • 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:
    • Drug: 10% intravenous immunoglobulin (IVIg)
    • Drug: 0.9% sodium chloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 19, 2015)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2018
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02372149
Other Study ID Numbers  ICMJE 14-8297-B
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ari Breiner, MD, University of Toronto
Study Sponsor  ICMJE University of Toronto
Collaborators  ICMJE University Health Network, Toronto
Investigators  ICMJE
Principal Investigator: Ari Breiner, MD, FRCPC University of Toronto
PRS Account University of Toronto
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP