The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes
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|ClinicalTrials.gov Identifier: NCT02915263|
Recruitment Status : Unknown
Verified July 2020 by Christopher Gibbons, MD, Beth Israel Deaconess Medical Center.
Recruitment status was: Recruiting
First Posted : September 27, 2016
Last Update Posted : July 15, 2020
The goal of this pilot study is to obtain preliminary data on the magnitude of the treatment effect of IVIG on the neuropathic pain and neuropathy severity associated with treatment induced neuropathy (TIND).
The investigators hypothesize that immune globulin, administered intravenously (IVIG), will reduce the pain associated with treatment induced neuropathy and reduce the neuropathy severity.
Treatment induced neuropathy in diabetes, is an iatrogenic complications of diabetes. The preliminary data will be used to power a larger treatment trial, and to aid the understanding of the mitigating factors in the treatment response.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Complications Diabetes Mellitus Diabetic Neuropathies||Drug: IGIV-C Drug: 0.9% Sodium Chloride||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled Trial To Evaluate The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes|
|Actual Study Start Date :||September 11, 2017|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
Placebo Comparator: 0.9% Sodium Chloride
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The placebo will consist of 0.9% Sodium Chloride per day over 5 days. Participants who are randomized to placebo will receive the same volume as they would if they were randomized to IVIG (i.e.: as if receiving IVIG at 2gm/kg) through a peripheral IV line.
Drug: 0.9% Sodium Chloride
Sodium Chloride (also known as saline) is a solution of sodium chloride, or salt, and sterile water.
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The treatment will consist of IVIG administered at 2 grams/kg divided over 5 days, with a follow up treatment 3 weeks (+/-3 days) later of IVIG 1gram/kg administered over 2 day (or placebo).
Gamunex-C [immune globulin injection (human) 10% caprylate/chromatography purified] is a sterile solution of human immune globulin protein.
- Change in sensory neuropathy as measured by the Utah Early Neuropathy Score (UENS). [ Time Frame: 7 weeks after first infusion ]The Utah Early Neuropathy Scale (UENS) was developed specifically to detect and quantify early small-fiber sensory neuropathy and to recognize modest changes in sensory severity and distribution.
- Change in neuropathic pain severity as measured by the pain visual analogue scores (VAS). [ Time Frame: 7 weeks after first infusion ]The visual analog scale (VAS) of pain allows for quantification of neuropathic pain (line from 0: no pain to 10:worst pain)
- Change in neuropathy severity as measured by skin biopsies. [ Time Frame: 7 weeks after first infusion ]Skin biopsies will be evaluated by measuring the Intra-epidermal nerve fiber density
- Change in Autonomic Neuropathy as measured by standardized autonomic nervous system testing. [ Time Frame: 7 weeks after first infusion ]The standardized autonomic nervous system testing evaluates the heart rate variability to paced breathing, the heart rate and blood pressure response to the Valsalva maneuver, the blood pressure response to tilt table testing, and sudomotor function testing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915263
|Contact: Katherine Senechalfirstname.lastname@example.org|
|Contact: Johanna Celliemail@example.com|
|United States, Massachusetts|
|Beth Israel Deaconness Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator: Christopher Gibbons, MD|
|Principal Investigator:||Christopher Gibbons, MD||Beth Israel Deaconess Medical Cednter|