There are several clinical trials in process right now that support research for GBS, CIDP, and variants. Please note that this information is intended to help patients be aware of all of their options; the Foundation is unable to endorse any clinical trials.
The international GBS Outcome Study (IGOS) is the largest and longest prospective trial designed to collect extensive data from patients afflicted with GBS in a systematic manner. The aim is to collect information from patients by intensive international collaboration. All patients are followed at standard intervals from the earliest phase of the disease up to at least one year after. At these time points all patients are clinically examined and documented according to the same protocol. The data generated from IGOS may fundamentally change how we care for patients with GBS and hasten research for more effective therapies.
The GBS|CIDP Foundation International is currently funding the IGOS trial through a research grant.
ADVANCE CIDP 1 Clinical Study
An international phase III study is looking at an investigational immunoglobulin medication that can be given as an infusion under the skin. The study will look at whether the investigational medication is safe and effective at treating patients with CIDP. In some countries, people with CIDP are given immunoglobulin as an infusion under the skin. This means that they can potentially have their treatment at home. However, doses may need to be received more often than when immunoglobulin is given as an infusion into the vein. This is because the body cannot absorb medication through tissue as effectively as it can through veins.
The investigational medication in the ADVANCE CIDP 1 study contains a substance that may help improve how well the body can absorb the immunoglobulin when it is given as an infusion under the skin. It is hoped that this could mean that people can have the same dose each month as they would if they were given it by infusion into the vein.
The study is divided into three periods. The length of your participation in the study will be between 8 and 14 months.
Hematopoietic Stem Cell Transplantation in Chronic Inflammatory Demyelinating Polyneuropathy
HSCT is a treatment where a patient’s own stem cells are collected from their peripheral blood, high-dose chemotherapy is administered to eliminate the patient’s defective immune system, and then the previously collected stem cells are reinfused to aid in the regeneration of a healthy immune system. For some patients with autoimmune diseases such as CIDP this agressive immunotherapy approach may lead to disease remission.
Northwestern University in Chicago, IL, is currently conducting a US FDA approved phase II clinical trial to explore the effectiveness of HSCT in patients with severe CIDP that is refractory to conventional medications such as IVIg and steroids.
A Study of Subcutaneous Immunoglobulin (SCIg) as Chronic Treatment for Patients With Chronic Inflammatory Demyelinating Polyneuropathy
While effective, IVIG causes systemic side effects in about 5% of patients. These side effects include rash, pruritus, myalgia, fever, chills, headache, low back pain, nausea, vomiting, changes in blood pressure or heart rate, renal failure, and aseptic meningitis (Berger, 2008). For many patients who are chronically treated with IVIG, venous access may be a problem over time. An alternative is the subcutaneous (SC) route, which has been in use since 1980 for primary immune deficiency disorders and is the treatment of choice for this condition in Scandinavia and England (Radinsky et al, 2003).
This trial is currently looking for patients who have had adverse reactions from their IVIg, are assessing quality of life parameters, as well as the efficacy and safety of SCIg in this cohort. This study is looking to recruit a total of 15 subjects from the South Florida area.
IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength Measurements (GRIPPER)