Europas førende søgning efter kliniske forsøg

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 it can affect MRI lesion activity and how it performs in this patient group. The trial data here focus on a phase 2 study.

Table of contents

Trial overview

This clinical trial is studying Live Bcg Bacilli (Bacillus Calmette-Guerin), Brasilian Moreau Substrain in people with Radiologically Isolated Syndrome (RIS).[1] The study is authorised and is listed as a Phase 2 trial.[1] It is designed to look at MRI changes over time, especially the number of new active lesions seen during follow-up.[1]

Who is being studied

The target population is people with RIS.[1] RIS means MRI findings look similar to a disease pattern even though the person may not yet have clear symptoms.[1] The trial data provided here do not list extra eligibility details such as age limits or other health rules.[1]

Study design and phase

This is an interventional study, which means participants receive a study treatment or a control so researchers can compare outcomes.[1] The trial includes 100 participants.[1] As a Phase 2 study, it is mainly focused on learning more about whether the approach may help in this specific group.[1]

What the trial measures

The main endpoint is the cumulative number of CUAL on MRI scans over 1 year.[1] CUAL stands for combined unique new active lesions, which means new MRI lesions that are counted together as a main measure of disease activity.[1] The brief study summary says these lesions are defined as new gadolinium T1-weighted and T2-weighted new and newly non-enhancing expansion findings.[1]

Treatments used in the study

The intervention list includes Live Bcg Bacilli (Bacillus Calmette-Guerin), Brasilian Moreau Substrain and a saline solvent control.[1] The trial data describe the solvent as sodium chloride 0.9% for parenteral use, and both listed products are given by intradermal use.[1] The source data do not provide more treatment details beyond these study materials.[1]

Patient-friendly terms

Radiologically Isolated Syndrome means the MRI shows changes that may look important, but the person may not yet feel sick or have clear symptoms.[1] MRI is a scan that makes detailed pictures of the brain and can help doctors track changes over time.[1] A lesion is an area on the scan that looks different from normal tissue.[1] A primary endpoint is the main result researchers plan to measure in the study.[1]

Study focus in simple words

In simple terms, this trial is trying to see how MRI findings change over 1 year in people with RIS who are part of the study.[1] The main question is whether the number of new active MRI lesions can be measured and compared during follow-up.[1] The study is not described here as a treatment guide, but as a research project focused on MRI outcomes in a specific patient group.[1]

Trial ID Phase Condition studied Status Enrollment
2024-518901-16-00 Phase 2 RIS (Radiologically Isolated Syndrome) Authorised 100

FAQ

  • What is being studied in these clinical trials? The trial is studying Live Bcg Bacilli (Bacillus Calmette-Guerin), Brasilian Moreau Substrain in people with Radiologically Isolated Syndrome (RIS). The main focus is MRI lesion activity over time.
  • Who can take part in the trial? The target group is people with RIS, which means MRI findings suggest a risk pattern even when symptoms may not yet be present. The trial data do not give more detailed eligibility rules.
  • What phase is this trial? This is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment has a useful effect in a specific patient group.
  • What outcome is the trial measuring? The main outcome is the cumulative number of CUAL on MRI scans over 1 year. CUAL means combined unique new active lesions, which are new areas seen on brain MRI that show activity or change.
  • What kind of study is this? This is an interventional study, which means participants receive a study treatment or control so researchers can compare outcomes. In this trial, the study includes Live Bcg Bacilli (Bacillus Calmette-Guerin), Brasilian Moreau Substrain and a saline solvent.

Igangværende kliniske forsøg for Live Bcg Bacilli (Bacillus Calmette-Guerin), Brasilian Moreau Substrain

  • Undersøgelse af BCG-vaccine til forebyggelse af hjernelæsioner hos personer med RIS (radiologisk isoleret syndrom)

    Rekrutterer

    1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Italien

Ordliste

  • Radiologically Isolated Syndrome (RIS): A finding on MRI where changes look like a disease pattern, but the person may not have clear symptoms yet.
  • Phase 2: A stage of clinical research that looks at early signs of benefit in a defined patient group.
  • Interventional study: A trial where researchers give a treatment or control to see what happens.
  • MRI: Magnetic resonance imaging, a scan that makes detailed pictures of the inside of the body, especially the brain and spinal cord.
  • Lesion: An area of tissue that looks different from normal on a scan.
  • Active lesion: A lesion that shows signs of current change or activity on MRI.
  • Gadolinium: A contrast dye used in some MRI scans to show areas with active change more clearly.
  • T1-weighted: A type of MRI image that helps show certain tissue changes, often used with contrast dye.
  • T2-weighted: A type of MRI image that can show changes in tissue, including new lesions.
  • CUAL: Combined unique new active lesions, meaning new MRI lesions that are counted together as a main study measure.

Referencer

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