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

• Status: Recruiting
• Trial end date: 2022-11-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital

Criteria

Inclusion Criteria:

• 1. Clinically confirmed cerebellar ataxia with a SARA total score ≥ 3 (range 0-40).

• 2. Clinical diagnosis of probable or possible MSA-C.

• 3. Patients older than 18 years old and younger than 80 years old.

Exclusion Criteria:

• 1. Major systemic diseases such as hepatic, renal or heart failure, malignancy, stroke.

• 2. Concomitant medication which inhibit CYP2C19 enzyme such as Clopidogrel, cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, fluoxetine, fluvoxamine, ticlopidine.

• 3. Pregnancy and/or breastfeeding.

• 4. Acute diseases that might interfere with the trial.