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

NCT ID: NCT03901638

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2023-04-03

Brief 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.

Detailed 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.

Conditions

Ataxia, Cerebellar; Multiple System Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tllsh2910 to placebo

Tllsh2910 160mg per day for 12 weeks with wash-out period 12 weeks and subsequent placebos for 12 weeks.

Group Type: EXPERIMENTAL

Tllsh2910

Intervention Type: DRUG

Tllsh2910 80mg twice per day orally for 12 weeks

Placebo

Intervention Type: DRUG

Placebo

Placebo to Tllsh2910

Placebos for 12 weeks with wash-out period 12 weeks and subsequent Tllsh2910 160mg per day for 12 weeks

Group Type: EXPERIMENTAL

Tllsh2910

Intervention Type: DRUG

Tllsh2910 80mg twice per day orally for 12 weeks

Placebo

Intervention Type: DRUG

Placebo

Interventions

Tllsh2910

Tllsh2910 80mg twice per day orally for 12 weeks

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chun-Hwei Tai

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital (NTUH)

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201810015MINC

Identifier Type: -

Identifier Source: org_study_id