Trial results for a study investigating endovascular therapy in Multiple Sclerosis were posted on ClinicalTrials.gov on 2025-08-22, reporting no serious adverse events among its 30 participants.
Background
Multiple Sclerosis (MS) is a chronic, autoimmune disease affecting the brain and spinal cord, leading to a range of neurological symptoms. While current treatments focus on managing symptoms and slowing disease progression, research has explored various potential contributing factors and interventions. This particular study investigated endovascular therapy for venous stenoses in MS patients, based on the hypothesis of Chronic Cerebrospinal Venous Insufficiency (CCSVI), aiming to assess its safety and preliminary efficacy.
Trial design
This completed study, designated as Phase NA, enrolled 30 participants with Multiple Sclerosis. The trial, titled "Prospective Randomized Endovascular Therapy in Multiple Sclerosis," aimed to assess the safety of endovascular therapy (balloon angioplasty) for venous stenoses in MS patients with CCSVI as documented by sonographic methods. It also sought to study the morphology of venous anomalies using intraluminal ultrasound (IVUS) and evaluate preliminary efficacy through clinical (relapse rate, disability progression (EDSS)), sonographic, and MRI/MRV parameters, as well as patient-reported quality of life. The study design included groups receiving Venous Angioplasty and Angio With no Plasty.
Key results
The trial reported on the safety of the interventions, specifically the percentage of patients experiencing immediate and short-term serious adverse events (SAE).
- For the Venous Angioplasty group, the count of participants with immediate and short-term SAE was 0.
- For the Angio With no Plasty group, the count of participants with immediate and short-term SAE was 0.
What this means
The posted results indicate that in this small study of 30 participants, endovascular therapy (balloon angioplasty) for venous stenoses in Multiple Sclerosis patients was not associated with immediate or short-term serious adverse events in either the active angioplasty group or the control angio group. This suggests a favorable safety profile within the scope of this trial. However, the study's primary outcomes are not detailed in the posted results, and efficacy data would be necessary to understand the full clinical implications for patients with Multiple Sclerosis.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05380362, titled "Prospective Randomized Endovascular Therapy in Multiple Sclerosis," were posted on 2025-08-22 on clinicaltrials.gov.