Table of contents
- Trial overview
- Who can participate
- Study design and treatment groups
- What the trial measures
- Trial status and size
Trial overview
The available clinical trial is studying ACT-1004-1239 in adults with progressive multiple sclerosis, also called progressive MS.[1] 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.[1]
Who can participate
This trial is for adults with progressive multiple sclerosis.[1] The source data does not list more detailed eligibility rules, such as specific lab tests or disease limits.[1]
Study design and treatment groups
This is an interventional study, which means researchers give a study treatment and compare outcomes between groups.[1] The trial includes ACT-1004-1239 and a matching placebo, which is a look-alike treatment with no active study drug.[1] The source data also lists oral ACT-1004-1239 as part of the intervention details.[1]
The study is in Phase 2.[1] 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.[1]
What the trial measures
The main outcome is the change from baseline to Week 24 in myelin water fraction (MWF) of the corpus callosum.[1] Baseline means the starting point before treatment, and Week 24 means 24 weeks after the study begins.[1]
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.[1] In this trial, MRI is being used to look for signs of remyelination, which is the rebuilding of myelin.[1]
Trial status and size
The trial is listed as Authorised.[1] It has an enrollment of 32 participants, so it is a small study.[1] The trial title says it is assessing efficacy and safety of ACT-1004-1239 in adults with progressive MS.[1]
