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Trial record 25 of 104 for:    "Brain Diseases" AND "Multiple System Atrophy"

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

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ClinicalTrials.gov Identifier: NCT03901638
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE March 24, 2019
First Posted Date  ICMJE April 3, 2019
Last Update Posted Date April 3, 2019
Estimated Study Start Date  ICMJE April 2, 2019
Estimated Primary Completion Date November 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
=Scale for the assessment and rating of ataxia (SARA) score [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks ]
SARA is an 8-item performance based scale with gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternative hand movements, and heel-shin slide, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia). The change in the SARA score will be recorded from period-level baseline to the end of the 12-week, 24-week, 36-week treatment period.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
  • International Cooperative Ataxia Rating Scale (ICARS) score [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks ]
    ICARS is an 19-item performance based scale with 4 subscales of postural and gait disturbances, kinetic function, speech disorders, and oculomotor disorders, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia). The change in the ICARS score will be measured from period-level baseline to the end of the 12-week, 24-week, 36-week treatment period.
  • Unified multiple system atrophy rating scale (UMSARS) Part II score [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks ]
    UMSARS is an validated 26-items scale for multiple system atrophy with 4 subscales of historical review, motor examination scale, autonomic examination, and global disability scale. The Part II is a performance based subscale, yield a total score of 0 (no motor impairment) to 56 (most severe motor impairment). The change in the UMSARS Part-II score will be measured from period-level baseline to the end of the 12-week, 24-week, 36-week treatment period.
  • The composition change of gut microbiota [ Time Frame: Baseline, 12 weeks ]
    The gut microbiota will be measured at baseline and 12th weeks.
  • The change of total time needed for a 8-meter walking test [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks ]
    Total time of 8-meter walking test will be measured from period-level baeline to the end of the 12-week, 24-week, and 36-week.
  • The change of the World Health Organization Quality of Life (WHOQOL-BREF) scale [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks ]
    The WHOQOL-BREF scale is a 28-item questionnaire about quality of life. The change of WHOQOL-BREF scores will be measured at baseline, 12-week, 24-week, and 36-week.
  • The total time needed for 9 hole peg test [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks ]
    The total time needed for 9 hole peg test will be measured at the baseline, 12-week, 24-week, and 36-week.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tllsh2910 for Ataxia and Gut Microbiota Alteration in Patients of Multiple System Atrophy
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Ataxia, Cerebellar
  • Multiple System Atrophy
Intervention  ICMJE
  • Drug: Tllsh2910
    Tllsh2910 80mg twice per day orally for 12 weeks
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Tllsh2910 to placebo
    Tllsh2910 160mg per day for 12 weeks with wash-out period 12 weeks and subsequent placebos for 12 weeks.
    Interventions:
    • Drug: Tllsh2910
    • Drug: Placebo
  • Experimental: Placebo to Tllsh2910
    Placebos for 12 weeks with wash-out period 12 weeks and subsequent Tllsh2910 160mg per day for 12 weeks
    Interventions:
    • Drug: Tllsh2910
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 15, 2021
Estimated Primary Completion Date November 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ming-Che Kuo 886-919992342 kuomingche0402@gmail.com
Contact: Shau-Hua Kuo 886-911606669 sarakuo1988@gmail.com
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03901638
Other Study ID Numbers  ICMJE 201810015MINC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chun-Hwei Tai National Taiwan University Hospital (NTUH)
PRS Account National Taiwan University Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP