Trial · NCT02008721
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change of Score in Motor Examination (ME) of the Unified MSA Rating Scale (UMSARS-ME) From V1 to V7. | 52 weeks | Eligible patients were older than 30 years; met the diagnostic criteria for possible or probable parkinsonism-predominant or cerebellar-ataxia-predominant multiple system atrophy; could ambulate independently (ie, Hoehn and Yahr stages 1-3); and had to be on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens. | score on a scale | MEAN |
| SECONDARY | Possible Symptomatic Effects of EGCG vs. Placebo Measured by the Change in the UMSARS - ME in the Wash-out Phase (From V6-V7) | 4 weeks | Eligible patients were older than 30 years; met the diagnostic criteria for possible or probable parkinsonism-predominant or cerebellar-ataxia-predominant multiple system atrophy; could ambulate independently (ie, Hoehn and Yahr stages 1-3); and had to be on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens. | score on a scale | MEAN |
| SECONDARY | Change in the UMSARS Total Score From V1 to V7 | 52 weeks | Eligible patients were older than 30 years; met the diagnostic criteria for possible or probable parkinsonism-predominant or cerebellar-ataxia-predominant multiple system atrophy; could ambulate independently (ie, Hoehn and Yahr stages 1-3); and had to be on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens. | score on a scale | MEAN |
| SECONDARY | Possible Symptomatic Effects of EGCG vs. Placebo Measured by the UMSARS Total Score From V6 to V7 (During the Washout Phase) | 4 weeks | Eligible patients were older than 30 years; met the diagnostic criteria for possible or probable parkinsonism-predominant or cerebellar-ataxia-predominant multiple system atrophy; could ambulate independently (ie, Hoehn and Yahr stages 1-3); and had to be on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens. | score on a scale | MEAN |
| SECONDARY | Percentage of Striatal Volume Loss in MRI (3D MP-RAGE MRI Volumetry, 3D FLAIR) From Baseline to V7 as Effect of Treatment (Epigallocatechin Gallate vs Placebo) | baseline to 52 weeks | 17 patients in the EGCG-group and 15 patients in the placebo group took part in the MRI substudy.~A reduced number of 11 patients were analysed in the EGCG group and 8 patients in the Placebo group, as only these patients had taken part in the follow-up MRI assessments. | % of volume loss | MEAN |
| SECONDARY | Clinical Safety and Tolerability of EGCG Measured by Death Rates | 52 weeks | Eligible patients were older than 30 years; met the diagnostic criteria for possible or probable parkinsonism-predominant or cerebellar-ataxia-predominant multiple system atrophy; could ambulate independently (ie, Hoehn and Yahr stages 1-3); and had to be on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Effect of Treatment (Epigallocatechin Gallate vs Placebo) on Safety and Tolerability: Discontinuation Rates Because of Hepatotoxicity | 52 weeks | Eligible patients were older than 30 years; met the diagnostic criteria for possible or probable parkinsonism-predominant or cerebellar-ataxia-predominant multiple system atrophy; could ambulate independently (ie, Hoehn and Yahr stages 1-3); and had to be on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving Each Clinical Global Impression of Severity (CGI-S): Illness Level at Visit 1 | At baseline visit (max. 4 weeks after the screening visit) | Eligible patients were older than 30 years; met the diagnostic criteria for possible or probable parkinsonism-predominant or cerebellar-ataxia-predominant multiple system atrophy; could ambulate independently (ie, Hoehn and Yahr stages 1-3); and had to be on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens. | participants | NUMBER |
| SECONDARY | Number of Participants Achieving Each Clinical Global Impression of Severity (CGI-S): Illness Level at Visit 5 | Visit 5 (30 weeks after Baseline Visit) | Eligible patients were older than 30 years; met the diagnostic criteria for possible or probable parkinsonism-predominant or cerebellar-ataxia-predominant multiple system atrophy; could ambulate independently (ie, Hoehn and Yahr stages 1-3); and had to be on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens.~In the EGCG group only 36 of 47 patients provided data at visit 5 due to SAE/drop out; likewise in the placebo group only 37 of 45 patients. | participants | NUMBER |
| SECONDARY | Number of Participants Achieving Each Clinical Global Impression of Severity (CGI-S): Illness Level at Visit 6 | 48 weeks after baseline visit | Eligible patients were older than 30 years; met the diagnostic criteria for possible or probable parkinsonism-predominant or cerebellar-ataxia-predominant multiple system atrophy; could ambulate independently (ie, Hoehn and Yahr stages 1-3); and had to be on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens.~In the EGCG group only 32 of 47 patients provided data at visit 6 due to SAE/drop out; likewise in the placebo group only 35 of 45 patients. | participants | NUMBER |
| SECONDARY | Number of Participants Achieving Each Clinical Global Impression of Severity (CGI-S): Illness Level at Visit 7 | 52 weeks after baseline visit | Eligible patients were older than 30 years; met the diagnostic criteria for possible or probable parkinsonism-predominant or cerebellar-ataxia-predominant multiple system atrophy; could ambulate independently (ie, Hoehn and Yahr stages 1-3); and had to be on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens.~In the EGCG group only 23 of 47 patients provided data at visit 7 due to SAE/drop out; likewise in the placebo group only 37 of 45 patients. | participants | NUMBER |
| SECONDARY | Number of Participants Achieving Each Clinical Global Impression of Improvement (CGI-I): Improvement Level at Visit 7 Compared to the Baseline Visit | Visit 7: 52 weeks after baseline visit | Eligible patients were older than 30 years; met the diagnostic criteria for possible or probable parkinsonism-predominant or cerebellar-ataxia-predominant multiple system atrophy; could ambulate independently (ie, Hoehn and Yahr stages 1-3); and had to be on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens.~In the EGCG group only 32 of 47 patients provided data at visit 5 due to SAE/drop out; likewise in the placebo group only 35 of 45 patients. | participants | NUMBER |
| SECONDARY | Number of Participants Achieving Each Clinical Global Impression of Improvement (CGI-I): Efficacy Index (Therapeutic Effect of Treatment With Medication and Associated Side Effects) at Visit 7 Compared to the Baseline Visit | Visit 7: 52 weeks after baseline visit | Eligible patients were older than 30 years; met the diagnostic criteria for possible or probable parkinsonism-predominant or cerebellar-ataxia-predominant multiple system atrophy; could ambulate independently (ie, Hoehn and Yahr stages 1-3); and had to be on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens.~In the EGCG group only 32 of 47 patients provided data at visit 5 due to SAE/drop out; likewise in the placebo group only 30 of 45 patients. | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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