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The objective of this study is to describe disease progression in study participants diagnosed with early Parkinson's Disease or Multiple System Atrophy - Parkinsonian Type up to 18 months as delineated by clinical and biochemical parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Parkinson's disease |
| ||
| Possible or Probable MSA-P |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| This is an observational study. | Other | This is an observational study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Motor symptoms as assessed by the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Change from baseline in the MDS-UPDRS. The MDS-UPDRS contains 4 subscales: Part I, non-motor aspects of experiences of daily living (13 items); Part II, motor aspects of experiences of daily living (13 items); Part III, motor examination (33 scores based on 18 items); Part IV, motor complications (6 items). The rating for each item, or sub-item, is from 0 (normal) to 4 (severe). The total score for each Part is obtained from the sum of the corresponding item scores. | 18 months |
| MSA symptoms/signs as assessed by the Unified Multiple System Atrophy Rating Scale (UMSARS) | Change from baseline in the Unified Multiple System Atrophy Rating Scale (UMSARS) and compared to placebo. UMSARS total scores range from 0-104 points with higher scores indicating greater severity of impairment. | 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the quality of life as measured by Parkinson's Disease Questionnaire (PDQ-39) | Change from baseline in the Parkinson's Disease Questionnaire (PDQ-39). PDQ-39 is a self-reported 39-item questionnaire designed to measure health related quality of life in Parkinson's Disease patients. It provides scores in 8 domains: mobility, activities of daily living, emotions, stigma, social support, cognitive function, bodily discomfort and communication, as well as a summary index score for quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Participants will have a diagnosis of early Parkinson's disease OR possible or probably MSA-P
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Irvine | California | 92697 | United States | ||
| Parkinson's Disease and Movement Disorders Center of Boca Raton |
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| 18 months |
| Change in the quality of life as measured by Multiple System Atrophy Quality of Life (MSA-QoL) | Change from baseline in the Multiple System Atrophy Quality of Life (MSA-QoL) scale. MSA-QoL is a self-reported questionnaire that measures MSA impact in day to day activities. Scale consists of 40 items with a five response option format (0 - no problem to 4 extreme problem) and a "not applicable" response option. | 18 months |
| Boca Raton |
| Florida |
| 33486 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | United States |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | United States |
| OHSU Parkinson Center & Movement Disorders Program | Portland | Oregon | 97239 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Zespol Poradni Specjalistycznych - Botaniczna 3 Poradnia Neurologiczna Szpital Uniwersytecki w Krakowie | Krakow | Lesser Poland Voivodeship | Poland |
| Specjalistyczna Praktyka Lekarska, Prof. Grzegorz Opala | Katowice | Poland |
| Mazowiecki Szpital Bródnowski w Warszawie, Oddział Neurologii | Warsaw | Poland |
| Samodzielny Publiczny Szpital Kliniczny im. prof. Witolda Orłowskiego, Oddział Neurologii i Epileptologii | Warsaw | Poland |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D019578 | Multiple System Atrophy |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
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