Tllsh2910 for Ataxia and Gut Microbiota Alteration in Patients of Multiple System Atrophy

Multiple System Atrophy Clinical Trial

Official title: Gut Microbiota Alteration and Improvement of Ataxia in Patients of Multiple System Atrophy Treating With Tllsh2910 - a Randomized, Placebo-controlled, Double-blinded, Cross-over, Single-center Clinical Trial

Status Terminated

Clinical Trial Summary

Multiple system atrophy (MSA) is a fetal, rare neurodegenerative disease presenting with parksinonism, autonomic dysfunction, and cerebellar ataxia. Numerous anti-parkinsonism agents have been developed. However, no medication has yet been proven effective for the symptomatic or even causative treatment in cerebellar ataxia. To our knowledge, cerebellar N-methyl-D- aspartic acid (NMDA) receptors play a special role in the modulation of motor learning and coordination. Tllsh2910, a NMDA modulator, has been found to attenuate the ataxic gait in the mouse model. Here, we designed a large-scale double-blind randomized controlled, cross-over phase III trial to investigate the efficacy of Tllsh2910 in neurodegenerative ataxic patients and the association of gut microbiota change.

Clinical Trial Description

The study is terminated prematurely due to project replanning and difficulty in recruitment during the pandemic. The overall sample size is not adequate to meet the requirement of estimated power. The statistical results will be investigated. No severe drug-related adverse events were reported during the study period. ;

Related Conditions & MeSH terms

• Ataxia
• Ataxia, Cerebellar
• Atrophy
• Cerebellar Ataxia
• Multiple System Atrophy
• Shy-Drager Syndrome

• NCT number: NCT03901638
• Study type: Interventional
• Source: National Taiwan University Hospital
• Status: Terminated
• Phase: Phase 3
• Start date: April 2, 2019
• Completion date: April 3, 2023