Trial · NCT02008721
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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 |
| Secondary | Number of Participants Achieving Each Clinical Global Impression of Severity (CGI-S): Illness Level at Visit 7 | 52 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 Improvement (CGI-I): Improvement Level at Visit 7 Compared to the Baseline Visit | Visit 7: 52 weeks after baseline visit | The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Compared to the patient's condition at baseline, this patient's condition has either improved or worsened or is unchanged, with a lower score meaning more improvement and a higher score less improvement or worsening respectively. The patient´s state compared to baseline is rated as: 1. Very much improved 2. much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7 = Very much worse |
| 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 | The Clinical Global Impression - Efficacy Index is a 4×4 rating scale that assesses the therapeutic effect of treatment with psychiatric medication and associated side effects. It comprises 4 Items for the therapeutic effect: 1. Marked - Vast improvement. Complete or nearly complete remission of all symptoms 2. Moderate - Decided improvement. Partial remission of symptoms 3. Minimal - Slight improvement which doesn't alter status of care of patient 4. Unchanged or worse combined with 4 items of possible side effects: 1= None - no side effects (S.E.) 2= Side effects (S.E.) do not significantly interfere with patient's functioning 3= S.E. significantly interfere with patient's functioning 4= S. E. outweigh therapeutic effect The lowest total score (score 1) means vast improvement with no side effects; the highest total score (score 16) means unchanged or worse patient´s condition with side effects that outweigh the therapeutic effect. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02008721/registered