Clinical trial
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
Name
201810015MINC
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.
Trial arms
Trial start
2019-04-02
Estimated PCD
2023-04-03
Trial end
2023-04-03
Status
Terminated
Phase
Early phase I
Treatment
Tllsh2910
Tllsh2910 80mg twice per day orally for 12 weeks
Arms:
Placebo to Tllsh2910, Tllsh2910 to placebo
Placebo
Placebo
Arms:
Placebo to Tllsh2910, Tllsh2910 to placebo
Size
18
Primary endpoint
=Scale for the assessment and rating of ataxia (SARA) score
Baseline, 12 weeks, 24 weeks, 36 weeks
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}
Updated at
2023-04-07
1 organization
1 product
1 drug
3 indications
Organization
National Taiwan University HospitalProduct
Tllsh2910Indication
AtaxiaIndication
cerebellumIndication
Multiple System AtrophyDrug
Varlilumab