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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 April 2023 |
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Main ID: |
NCT03901638 |
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Date of registration:
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24/03/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Tllsh2910 for Ataxia and Gut Microbiota Alteration in Patients of Multiple System Atrophy
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Scientific title:
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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 |
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Date of first enrolment:
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April 2, 2019 |
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Target sample size:
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18 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03901638 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Chun-Hwei Tai |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Taiwan University Hospital (NTUH) |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ataxia, Cerebellar
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Multiple System Atrophy
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Intervention(s)
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Drug: Tllsh2910
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Drug: Placebo
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Primary Outcome(s)
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=Scale for the assessment and rating of ataxia (SARA) score
[Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks]
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Secondary Outcome(s)
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International Cooperative Ataxia Rating Scale (ICARS) score
[Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks]
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The change of total time needed for a 8-meter walking test
[Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks]
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The total time needed for 9 hole peg test
[Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks]
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The change of the World Health Organization Quality of Life (WHOQOL-BREF) scale
[Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks]
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The composition change of gut microbiota
[Time Frame: Baseline, 12 weeks]
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Unified multiple system atrophy rating scale (UMSARS) Part II score
[Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks]
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Secondary ID(s)
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201810015MINC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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