Trial · NCT02008721
Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach
NCT02008721, Phase 3, Completed, Dr. Johannes Levin; results first posted 2024-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach. Trials, record NCT02008721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02008721
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach
- NCT number
- NCT02008721
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 92 participants, actual
- Lead sponsor
- Dr. Johannes Levin
- Conditions
- Multiple System Atrophy
- Interventions
- EGCG as putative neuroprotective agent, Placebo
- First posted
- 2013-12-11
- Last updated
- 2024-03-12
- Results first posted
- 2024-03-12
- Limitations and caveats
The PROMESA trial had several limitations. The trial was powered to detect a 50% reduction in disease progression, not to detect smaller changes.~Furthermore, the assummed dropout rate was 20% while the observed drop out rate was approximately 27%. Furthermore, center size was heterogeneous, only four of the 12 centres recruited ten or more patients.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of Score in Motor Examination (ME) of the Unified MSA Rating Scale (UMSARS-ME) From V1 to V7. | 52 weeks | To assess the efficacy of EGCG vs. Placebo to reduce the progression in the motor examination (ME) of the Unified MSA Rating Scale (UMSARS-ME) from V1 to V7. The UMSARS-ME (Unified Multiple System Atrophy Rating Scale, Motor examination) assesses 14 operationalised signs of multiple system atrophy. 25 Scores for all 14 items range from 0 to 4, thus total scores range from 0 to 56. Higher scores mean a worse outcome. |
| 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 | To assess any effect of EGCG vs. Placebo on the evolution of the above mentioned parameters during the wash-out phase (from V6-V7) measured by the UMSARS - ME. The UMSARS-ME (Unified Multiple System Atrophy Rating Scale, Motor examination) assesses 14 operationalised signs of multiple system atrophy. 25 Scores for all 14 items range from 0 to 4, thus total scores range from 0 to 56. Higher scores mean a worse outcome. |
| Secondary | Change in the UMSARS Total Score From V1 to V7 | 52 weeks | To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in UMSARS total score The total score of the UMSARS (Unified Multiple System Atrophy Rating Scale) is a disease specific rating scale that comprises the activities of daily living subscale and the motor examination subscale. The activities of daily living subscale assesses motor symptoms and autonomic symptoms (items 1-12 of the UMSARS activities of daily living subscale) with scores from 0-4 for every item, resulting in a minimum score of 0 and a maximum score of 48. A higher score means a worse outcome. It also includes the 14 items of the UMSARS motor examination subscale with possible scores from 0-4 for every item, resulting in a score range from 0-56. The UMSARS total score hence shows a range from 0 to 104. Higher scores indicate a greater impairment. |
| Secondary | Possible Symptomatic Effects of EGCG vs. Placebo Measured by the UMSARS Total Score From V6 to V7 (During the Washout Phase) | 4 weeks | To assess any effect of EGCG vs. Placebo on the UMSARS total score during the wash-out phase (from V6 to V7) to explore possible symptomatic effects. The total score of the UMSARS (Unified Multiple System Atrophy Rating Scale) is a disease specific rating scale that comprises the activities of daily living subscale and the motor examination subscale. The activities of daily living subscale assesses motor symptoms and autonomic symptoms (items 1-12 of the UMSARS activities of daily living subscale) with scores from 0-4 for every item, resulting in a minimum score of 0 and a maximum score of 48. A higher score means a worse outcome. It also includes the 14 items of the UMSARS motor examination subscale with possible scores from 0-4 for every item, resulting in a score range from 0-56. The UMSARS total score hence shows a range from 0 to 104, a higher score indicates greater impairment. |
| 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 | To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 (52 weeks) in striatal volume loss measured by MRI (3D MP-RAGE MRI volumetry, 3D FLAIR) |
| Secondary | Clinical Safety and Tolerability of EGCG Measured by Death Rates | 52 weeks | Clinical safety and tolerability of EGCG measured by number of deaths in EGCG- Group vs Placebo-Group |
| Secondary | Effect of Treatment (Epigallocatechin Gallate vs Placebo) on Safety and Tolerability: Discontinuation Rates Because of Hepatotoxicity | 52 weeks | Effect of Treatment (Epigallocatechin Gallate vs Placebo) on Safety and Tolerability: Measured by Discontinuation rates because of hepatotoxicity (measured by increased aminotransferase concentrations) |
| 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) | Clinical Global Impression of Severity (CGI-S) is a 7 item scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. Possible ratings are: 1. Normal, not at all ill 2. Borderline mentally ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Among the most extremely ill patients |
| 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) | Clinical Global Impression of Severity (CGI-S) is a 7 item scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. Possible ratings are: 1. Normal, not at all ill 2. Borderline mentally ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Among the most extremely ill patients |
| Secondary | Number of Participants Achieving Each Clinical Global Impression of Severity (CGI-S): Illness Level at Visit 6 | 48 weeks after baseline visit | Clinical Global Impression of Severity (CGI-S) is a 7 item scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. Possible ratings are: 1. Normal, not at all ill 2. Borderline mentally ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Among the most extremely ill patients |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group98
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change of Score in Motor Examination (ME) of the Unified MSA Rating Scale (UMSARS-ME) From V1 to V7. | EGCG as Putative Neuroprotective Agent | 5.66 | Standard Deviation 1.01 | score on a scale | |
| Change of Score in Motor Examination (ME) of the Unified MSA Rating Scale (UMSARS-ME) From V1 to V7. | Placebo | 6.60 | Standard Deviation 0.99 | score on a scale | |
| Possible Symptomatic Effects of EGCG vs. Placebo Measured by the Change in the UMSARS - ME in the Wash-out Phase (From V6-V7) | EGCG as Putative Neuroprotective Agent | 0.68 | Standard Deviation 0.60 | score on a scale | |
| Possible Symptomatic Effects of EGCG vs. Placebo Measured by the Change in the UMSARS - ME in the Wash-out Phase (From V6-V7) | Placebo | 0.49 | Standard Deviation 0.58 | score on a scale | |
| Change in the UMSARS Total Score From V1 to V7 | EGCG as Putative Neuroprotective Agent | 10.33 | Standard Deviation 1.73 | score on a scale | |
| Change in the UMSARS Total Score From V1 to V7 | Placebo | 10.35 | Standard Deviation 1.71 | score on a scale | |
| Possible Symptomatic Effects of EGCG vs. Placebo Measured by the UMSARS Total Score From V6 to V7 (During the Washout Phase) | EGCG as Putative Neuroprotective Agent | 0.70 | Standard Deviation 0.91 | score on a scale | |
| Possible Symptomatic Effects of EGCG vs. Placebo Measured by the UMSARS Total Score From V6 to V7 (During the Washout Phase) | Placebo | -0.29 | Standard Deviation 0.88 | score on a scale | |
| 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) | EGCG as Putative Neuroprotective Agent | -0.029 | Standard Deviation 0.027 | % of volume loss | |
| 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) | Placebo | -0.064 | Standard Deviation 0.026 | % of volume loss |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EGCG as Putative Neuroprotective Agent | 47 | |
| Overall Study | STARTED | Placebo | 45 | |
| Overall Study | Completion of Study Assessment | EGCG as Putative Neuroprotective Agent | 31 | |
| Overall Study | Completion of Study Assessment | Placebo | 33 | |
| Overall Study | Completion Without Protocol Violation | EGCG as Putative Neuroprotective Agent | 30 | |
| Overall Study | Completion Without Protocol Violation | Placebo | 33 | |
| Overall Study | Participation in MRI Substudy | EGCG as Putative Neuroprotective Agent | 17 | |
| Overall Study | Participation in MRI Substudy | Placebo | 15 | |
| Overall Study | Completion of MRI Substudy | EGCG as Putative Neuroprotective Agent | 11 | |
| Overall Study | Completion of MRI Substudy | Placebo | 8 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events50
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | UTI | Renal and urinary disorders | EGCG as Putative Neuroprotective Agent | 9 | 47 | 14 |
| other | UTI | Renal and urinary disorders | Placebo | 12 | 45 | 18 |
| other | urinary dysfunction | Renal and urinary disorders | EGCG as Putative Neuroprotective Agent | 3 | 47 | 3 |
| other | urinary dysfunction | Renal and urinary disorders | Placebo | 6 | 45 | 6 |
| other | dysarthria | Nervous system disorders | EGCG as Putative Neuroprotective Agent | 0 | 47 | 0 |
| other | dysarthria | Nervous system disorders | Placebo | 4 | 45 | 4 |
| other | dysphagia | Nervous system disorders | EGCG as Putative Neuroprotective Agent | 4 | 47 | 5 |
| other | dysphagia | Nervous system disorders | Placebo | 0 | 45 | 0 |
| other | falls | Nervous system disorders | EGCG as Putative Neuroprotective Agent | 17 | 47 | 26 |
| other | falls | Nervous system disorders | Placebo | 17 | 45 | 31 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EGCG as Putative Neuroprotective Agent | 4 | 47 |
| Total, all-cause mortality | Placebo | 2 | 45 |
| Total, other adverse events | EGCG as Putative Neuroprotective Agent | 25 | 47 |
| Total, other adverse events | Placebo | 33 | 45 |
| Total, serious adverse events | EGCG as Putative Neuroprotective Agent | 18 | 47 |
| Total, serious adverse events | Placebo | 8 | 45 |
Source ClinicalTrials.gov
Papers19
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| EGCG as Putative Neuroprotective Agent vs Placebo: Effect of Treatment (Epigallocatechin Gallate vs Placebo) on Safety and Tolerability: Discontinuation Rates Because of Hepatotoxicity | Trial comparisons |
| EGCG as Putative Neuroprotective Agent vs Placebo: Clinical Safety and Tolerability of EGCG Measured by Death Rates | Trial comparisons |
| EGCG as Putative Neuroprotective Agent vs Placebo: deaths from any cause | Trial comparisons |
| EGCG as Putative Neuroprotective Agent vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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Read this trial from software.
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