Efficacy of l-Arginine treatment in patients with HTLV-1-associated neurological disease.

ABSTRACT:

Objective

HTLV-1 infection causes HTLV-1-associated myelopathy/tropical spastic paraparesis (HAM/TSP), resulting in loss of motor function. In this Phase 2 trial, we assessed the efficacy and safety of l-arginine in patients with HAM/TSP.

Methods

This open-label, single-arm, Phase 2 study enrolled patients diagnosed with HAM/TSP. Patients received l-arginine at a dose of 20 g orally for 1 week and were followed-up for 3 weeks. The primary endpoint was change in walking speed in the 10-m walk test (10MWT). The main secondary endpoints were change in Timed Up and Go Test (TUGT) time, improvement in inflammatory markers in cerebrospinal fluid (CSF), safety, and tolerability.

Results

The study enrolled 20 patients (13 [65%] female) with a mean age of 67.8 years (95% CI 62

SUBMITTER: Nozuma S 

PROVIDER: S-EPMC9930431 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature