Trials / Unknown
UnknownNCT02372149
IVIg for Demyelination in Diabetes Mellitus
Treatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot Study
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- University of Toronto · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 10% intravenous immunoglobulin (IVIg) | |
| DRUG | 0.9% sodium chloride |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2018-02-01
- Completion
- 2018-02-01
- First posted
- 2015-02-26
- Last updated
- 2016-11-11
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02372149. Inclusion in this directory is not an endorsement.