Trial results for a study investigating endovascular therapy for Multiple Sclerosis were posted on 2025-06-18. The study, which enrolled 20 participants, reported no immediate or short-term serious adverse events, but also no improvement in venous outflow.
Background
Multiple Sclerosis (MS) is a chronic, often debilitating disease that affects the brain and spinal cord. While various treatments exist to manage symptoms and slow disease progression, research continues into potential new therapeutic approaches. This particular study explored the safety and effectiveness of intravascular angioplasty, a procedure aimed at treating venous narrowing, in the context of Multiple Sclerosis.
Trial design
The PREMiSE (Prospective Randomized Endovascular Therapy in Multiple Sclerosis) study was a completed trial that enrolled 20 participants with Multiple Sclerosis. The trial's objective was to evaluate the safety and effectiveness of intravascular angioplasty for the treatment of venous narrowing in MS. Participants were assigned to either a "Control Arm" or an "Active Arm" for evaluation. The trial phase was designated as "NA".
Key results
The trial reported on two key measurements:
- Percentage of Patients With Immediate and Short-term SAE:
- In the Control Arm, 0 Participants experienced immediate and short-term serious adverse events.
- In the Active Arm, 0 Participants experienced immediate and short-term serious adverse events.
- Number of Participants With More Than 75% of Normal Outflow at 1 Year Post-angioplasty:
- In the Control Arm, 0 Participants achieved more than 75% of normal outflow at 1 year post-angioplasty.
- In the Active Arm, 0 Participants achieved more than 75% of normal outflow at 1 year post-angioplasty.
What this means
Based on these results, the intravascular angioplasty procedure, as investigated in this small trial, appears to be safe, with 0 serious adverse events reported in both the active and control arms. However, the intervention did not demonstrate efficacy in improving venous outflow, as 0 participants in either arm achieved the target of more than 75% normal outflow at one year. This suggests that, within the parameters of this study, the intervention did not achieve its intended physiological effect for patients with Multiple Sclerosis. The small enrollment of 20 participants limits the generalizability of these findings.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study "Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE" were posted on 2025-06-18 on clinicaltrials.gov.