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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1254-1741 | Other Identifier | World Health Organization (WHO) |
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The main purpose of this study is to follow and observe a group of people living with Parkinson's disease to see how study participation affects their signs and symptoms in the months after starting in the study. While taking part in this study participants will take their usual medication as prescribed. However, the study doctor may recommend adjustments to their medication to provide a better treatment of their Parkinson's disease. Participation will last from 3 up to 24 months. During visits to the clinic, the study doctor or study nurse will evaluate signs and symptoms of Parkinson's disease using several different assessments. At a minimum of 2 visits participants will be asked to undergo 'off'-assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Parkinson's disease | Participants will not receive any investigational treatment in this study. The participants will be treated with anti-Parkinson's disease medication according to local standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment given | Other | Participants will not receive any investigational treatment in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (motor score) in OFF state | Measured as score. MDS-UPDRS consists of 4 parts - has 65 items/questions in total. Part III assesses the motor function of the patient at the time of the visit conducted in both the OFF and ON state. Each item will receive a score ranging from 0 to 4, where 0 represents the absence of impairment and 4 represents the highest degree of impairment. | From baseline (week 0) to end of study (13 to 104 weeks from baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in MDS-UPDRS Part III (motor score) in OFF state | Measured as score. MDS-UPDRS consists of 4 parts - has 65 items/questions in total. Part III assesses the motor function of the patient at the time of the visit conducted in both the OFF and ON state. Each item will receive a score ranging from 0 to 4, where 0 represents the absence of impairment and 4 represents the highest degree of impairment. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with Parkinson's disease will be included. The participants will not receive any investigational treatment in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joe C.Wen & Fam CTR for Adv Care | Irvine | California | 92612 | United States | ||
| NYU Langone Health |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| From last medication adjustment (between week 0 and week 104) to end of study (13 to 104 weeks from baseline) |
| Is the patient interested in being considered for participation in a cell therapy transplantation study (yes/no) | Measured as count of participants | At end of study (13 to 104 weeks from baseline) |
| New York |
| New York |
| 10016 |
| United States |
| NY Presbyt Hosp-W Cornell Med | New York | New York | 10021 | United States |
| Keio University Hospital | Shinjuku-ku, Tokyo | 160-8582 | Japan |
| Neurologimottagningen Lund | Lund | 222 42 | Sweden |
| Region Skane Skanes Universitetssjukhus | Lund | 222 42 | Sweden |
| Clinical Neuroscience | Cambridge | CB2 0PY | United Kingdom |
| University of Cambridge - Clinical Neuroscience | Cambridge | CB2 0PY | United Kingdom |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |