Safety and efficacy of venoplasty in MS: A randomized, double-blind, sham-controlled phase II trial.

ABSTRACT:

Objective

To determine the safety and efficacy of balloon vs sham venoplasty of narrowing of the extracranial jugular and azygos veins in multiple sclerosis (MS).

Methods

Patients with relapsing or progressive MS were screened using clinical and ultrasound criteria. After confirmation of >50% narrowing by venography, participants were randomized 1:1 to receive balloon or sham venoplasty of all stenoses and were followed for 48 weeks. Participants and research staff were blinded to intervention allocation. The primary safety outcome was the number of adverse events (AEs) during 48 weeks. The primary efficacy outcome was the change from baseline to week 48 in the patient-reported outcome MS Quality of Life-54 (MSQOL-54) questionnaire. Standardized clinical and MRI outcomes wer

SUBMITTER: Traboulsee AL 

PROVIDER: S-EPMC6207414 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature