NCT03901638

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

Terminated Phase 3 Last updated 7 April 2023

What this trial tests

Phase 3 trial testing Tllsh2910 in Ataxia, Cerebellar in 18 participants. Terminated before completion.

Timeline

2 April 2019

Primary endpoint
3 April 2023

3 April 2023

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	18
Start date	2 April 2019
Primary completion	3 April 2023
Estimated completion	3 April 2023
Sites	1 location across Taiwan

Drugs / interventions tested

• Tllsh2910 — full drug profile →
• Placebo

Conditions studied

• Ataxia, Cerebellar — all drugs for Ataxia, Cerebellar →
• Multiple System Atrophy — all drugs for Multiple System Atrophy →

Sponsor

National Taiwan University Hospital

Who can join

Adults 18 to 80, any sex, with Ataxia, Cerebellar or Multiple System Atrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current Management and Emerging Therapies in Multiple System Atrophy.
   Burns MR, McFarland NR. · · 2020 · cited 20× · PMID 32767032 · DOI 10.1007/s13311-020-00890-x
2. Multiple system atrophy: an update and emerging directions of biomarkers and clinical trials.
   Liu M, Wang Z, Shang H. · · 2024 · cited 19× · PMID 38483626 · DOI 10.1007/s00415-024-12269-5
3. Disease-Modifying Therapies for Multiple System Atrophy: Where Are We in 2022?
   Sidoroff V, Bower P, Stefanova N, Fanciulli A, et al · · 2022 · cited 16× · PMID 35491799 · DOI 10.3233/jpd-223183
4. Current Symptomatic and Disease-Modifying Treatments in Multiple System Atrophy.
   Mészáros L, Hoffmann A, Wihan J, Winkler J. · · 2020 · cited 16× · PMID 32316335 · DOI 10.3390/ijms21082775
5. Symptomatic Care in Multiple System Atrophy: State of the Art.
   Grossauer A, Sidoroff V, Heim B, Seppi K. · · 2023 · cited 11× · PMID 35581488 · DOI 10.1007/s12311-022-01411-6