Ongoing Clinical Trials for Radiologically Isolated Syndrome
There is currently 1 ongoing clinical trial investigating treatment options for Radiologically Isolated Syndrome (RIS), a condition where brain lesions similar to multiple sclerosis are detected on MRI scans without any clinical symptoms. The trial is testing the BCG vaccine to see if it can reduce the development of new brain lesions and potentially prevent progression to symptomatic disease.
Clinical trial locations
- Italy
Study of BCG Vaccine and Sodium Chloride for Patients with Radiologically Isolated Syndrome (RIS)
This trial is investigating whether the Bacille Calmette-Guérin (BCG) vaccine, traditionally used to prevent tuberculosis, can help people with Radiologically Isolated Syndrome. RIS is a unique situation where MRI scans show changes in the brain that look similar to those seen in multiple sclerosis, but the person has no symptoms. The concern is that some people with RIS may eventually develop symptoms and progress to multiple sclerosis.
Who can participate:
- Adults over 18 years of age, of any race or gender
- People diagnosed with RIS within the last five years
- Those who understand the study and agree to participate by signing an informed consent form
Who cannot participate:
- People with any medical condition other than RIS
- Those who fall outside the specified age range for the study
- Vulnerable populations such as pregnant women, children, or those unable to give informed consent
- Anyone who does not meet the specific health and safety requirements established for participant protection
What the trial involves:
The main goal of this study is to see whether the BCG vaccine can reduce the number of new active lesions appearing in the brain over one year. Participants will receive either the BCG vaccine or a placebo through an injection just under the skin. Throughout the study, regular MRI scans will be performed to track any new brain changes.
The researchers will monitor participants for up to three years to observe when and if any clinical symptoms appear. They will also examine various aspects of brain health, including the number and types of brain lesions, changes in brain volume, and other detailed measurements. Safety will be carefully assessed by monitoring any side effects and conducting regular laboratory tests.
The investigational treatment:
The BCG vaccine is being tested for its potential to stimulate the immune system in a way that might help control inflammation and prevent the progression of brain changes seen in RIS. While this vaccine is well-known for preventing tuberculosis, researchers are now exploring whether its immunomodulatory effects could benefit people with RIS by reducing the development of new brain lesions that appear on MRI scans.
Summary
Currently, only one clinical trial is actively recruiting patients with Radiologically Isolated Syndrome. This trial is being conducted in Italy and represents an innovative approach to potentially preventing the progression from RIS to symptomatic multiple sclerosis. The study focuses on repurposing the BCG vaccine, a well-established tuberculosis vaccine, to explore its effects on reducing brain inflammation and lesion development. This trial offers hope for individuals diagnosed with RIS who are concerned about their risk of developing clinical symptoms in the future. The three-year follow-up period will provide valuable information about both the immediate effects on brain lesions and the longer-term impact on disease progression.
