In short
Clinical trials are studying Live Bcg Bacilli (Bacillus Calmette-Guerin), Brasilian Moreau Substrain in people with Radiologically Isolated Syndrome (RIS). These studies aim to see whether the treatment can affect MRI findings and help understand its role in this condition. The main focus is on patients with RIS in a Phase 2 trial.
Key points
- Clinical trials of Live Bcg Bacilli (Bacillus Calmette-Guerin), Brasilian Moreau Substrain are being studied in people with Radiologically Isolated Syndrome (RIS). The main trial is a Phase 2 interventional study with 100 planned participants. Researchers are looking at MRI changes over 1 year, especially the number of combined unique new active lesions (CUAL). The goal is to see whether the treatment affects new active brain lesions in this condition. The trial is currently authorised.
Trial overview
The available trial is an interventional study, which means researchers give a study treatment and then measure what happens. It is studying Live Bcg Bacilli (Bacillus Calmette-Guerin), Brasilian Moreau Substrain in people with Radiologically Isolated Syndrome (RIS).
The trial title describes it as a BCG vaccine study in RIS, and the study is authorised.
Who is being studied
The target population is people with RIS. RIS means MRI scans show changes that look like a disease of the nervous system, even if the person may not have clear symptoms yet.
The trial plans to include 100 people. This number helps researchers follow MRI changes in a group large enough for analysis.
What is being measured
The main primary endpoint is the cumulative number of combined unique new active lesions, or CUAL, on MRI scans over 1 year. A primary endpoint is the main result the study uses to answer its research question.
CUAL includes new gadolinium T1-weighted lesions and T2-weighted new or newly non-enhancing expansion, as described in the study summary. In simple words, the researchers are counting new or changing areas seen on brain MRI over time.
Trial phase and design
This study is in Phase 2. Phase 2 trials usually look more closely at whether a treatment has an effect in the target group.
The intervention list shows intradermal use, which means the study treatment is given into the skin. The record also lists a saline solvent used for parenteral use, which is a sterile liquid used to prepare or give the study product.
Study status and size
The trial status is Authorised. This means the study has been approved to proceed in the source record.
The planned enrollment is 100 participants. Enrollment is the number of people the study aims to recruit.
Key patient points
- The study is focused on RIS, not on a broad mixed group of conditions.
- The main outcome is based on MRI findings over 1 year, so imaging is central to the research.
- The trial is Phase 2, so it is looking for signs of effect in the studied group.
- The record gives a planned sample size of 100 people, which helps define the study scale.