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Live Bcg Bacilli (Bacillus Calmette-Guerin), Brasilian Moreau Substrain

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.

Table of contents

Trial overview

The available trial is an interventional study, which means researchers give a study treatment and then measure what happens.[1] It is studying Live Bcg Bacilli (Bacillus Calmette-Guerin), Brasilian Moreau Substrain in people with Radiologically Isolated Syndrome (RIS).[1]

The trial title describes it as a BCG vaccine study in RIS, and the study is authorised.[1]

Who is being studied

The target population is people with RIS.[1] 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.[1] 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.[1] 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.[1] 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.[1] 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.[1] The record also lists a saline solvent used for parenteral use, which is a sterile liquid used to prepare or give the study product.[1]

Study status and size

The trial status is Authorised.[1] This means the study has been approved to proceed in the source record.

The planned enrollment is 100 participants.[1] 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.[1]

  • The main outcome is based on MRI findings over 1 year, so imaging is central to the research.[1]

  • The trial is Phase 2, so it is looking for signs of effect in the studied group.[1]

  • The record gives a planned sample size of 100 people, which helps define the study scale.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2024-518901-16-00Phase 2Radiologically Isolated Syndrome (RIS)Authorised100

FAQ

  • What are the trials of Live Bcg Bacilli (Bacillus Calmette-Guerin), Brasilian Moreau Substrain studying? The trial is studying whether this treatment changes MRI findings in people with RIS. The main measure is the number of new active brain lesions seen over 1 year.
  • Who can take part in these trials? The trial is focused on people with Radiologically Isolated Syndrome (RIS). RIS means MRI scans show changes that look like a disease, even if the person may not have symptoms.
  • What phase is the trial? This study is in Phase 2. Phase 2 trials usually look more closely at whether a treatment has an effect and continue to watch safety and response.
  • What result is the trial measuring? The main result is the cumulative number of combined unique new active lesions, called CUAL, on MRI scans over 1 year. This helps show whether new areas of activity appear in the brain.
  • How many people are planned for the trial? The trial plans to enroll 100 people. This gives researchers a group large enough to study MRI changes over time.

Ongoing Clinical Trials on Live Bcg Bacilli (Bacillus Calmette-Guerin), Brasilian Moreau Substrain

  • Study of BCG Vaccine and Sodium Chloride for Patients with Radiologically Isolated Syndrome (RIS)

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

Glossary

  • Radiologically Isolated Syndrome (RIS): A condition where MRI scans show changes that look like a nervous system disease, but the person does not yet have clear symptoms.
  • MRI scan: A test that uses magnetic fields to make detailed pictures of the inside of the body, especially the brain and spinal cord.
  • Phase 2: A trial stage that looks more closely at whether a treatment works and continues to collect safety information.
  • Interventional study: A study where researchers give a treatment or procedure and then measure what happens.
  • Enrollment: The number of people planned to join a study.
  • Primary endpoint: The main result the researchers want to measure to answer the study question.
  • Combined unique new active lesions (CUAL): A count of new active areas seen on MRI, including new gadolinium-enhancing T1 lesions and new or newly enlarging T2 lesions.
  • Gadolinium: A contrast material used in some MRI scans to help show active areas more clearly.
  • T1-weighted and T2-weighted: Different MRI image types that show body tissues in different ways and help doctors see changes more clearly.
  • Intradermal use: Given into the skin rather than into a vein or muscle.

References

  1. https://clinicaltrials.gov/study/2024-518901-16-00