In short
Clinical trials are investigating ACT-1004-1239 in adults with progressive multiple sclerosis. These studies aim to assess safety and efficacy, including whether the treatment may support remyelination, using MRI-based measures. The main trial is in a small group of adults with progressive MS.
Key points
- ACT-1004-1239 is being studied in adults with progressive multiple sclerosis. The available trial is a Phase 2 interventional study with 32 participants. It compares ACT-1004-1239 with placebo and looks at remyelination using MRI. The main measurement is the change in myelin water fraction of the corpus callosum from the start of the study to Week 24. The trial is authorised and focuses on both efficacy and safety.
Trial overview
The available clinical trial is studying ACT-1004-1239 in adults with progressive multiple sclerosis, also called progressive MS. The trial is designed to assess efficacy and safety, with a focus on whether the study treatment may affect remyelination, which means rebuilding myelin, the protective covering around nerve fibers.
Who can participate
This trial is for adults with progressive multiple sclerosis. The source data does not list more detailed eligibility rules, such as specific lab tests or disease limits.
Study design and treatment groups
This is an interventional study, which means researchers give a study treatment and compare outcomes between groups. The trial includes ACT-1004-1239 and a matching placebo, which is a look-alike treatment with no active study drug. The source data also lists oral ACT-1004-1239 as part of the intervention details.
The study is in Phase 2. Phase 2 trials are usually done to learn more about whether a treatment may work and to continue checking safety in a defined patient group.
What the trial measures
The main outcome is the change from baseline to Week 24 in myelin water fraction (MWF) of the corpus callosum. Baseline means the starting point before treatment, and Week 24 means 24 weeks after the study begins.
MWF is an MRI-based measure used to estimate myelin, and the corpus callosum is a large bundle of nerve fibers that connects the two sides of the brain. In this trial, MRI is being used to look for signs of remyelination, which is the rebuilding of myelin.
Trial status and size
The trial is listed as Authorised. It has an enrollment of 32 participants, so it is a small study. The trial title says it is assessing efficacy and safety of ACT-1004-1239 in adults with progressive MS.