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The purpose of this study was to show superiority of Rotigotine over placebo on improvement of depressive symptoms in subjects with idiopathic Parkinson's disease.
The study included a maximum 2-week Screening Period, a maximum 4-week Titration Period for early-stage Parkinson's disease or maximum 7-week Titration Period for advanced-stage Parkinson's disease, 8-week Maintenance Period, a maximum 6-day De-escalation Period for early-stage Parkinson's disease or maximum 12-day De-escalation Period for advanced-stage Parkinson's disease and 30-day Safety Follow-Up Period.
The maximum study durations for an individual subject with early-stage Parkinson's disease and with advanced-stage Parkinson's disease were 19 weeks and 23 weeks, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotigotine | Experimental | Rotigotine, daily doses, treatment group |
|
| Placebo | Placebo Comparator | Placebo, daily doses, placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine | Drug | Transdermal Patch Content: 2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to the End of Maintenance Period in the Score of the Hamilton Depression Scale (HAM-D) | The HAM-D consists of 17 items. Nine of the items are scored on a 5-point scale, ranging from 0 to 4. The remaining 8 items are scored on a 3-point scale, from 0 to 2. Therefore, the total score ranges between 0 to 52, with a cutoff score of 15/16 diagnosing major depressive disorder. | From Baseline (Week 0) to end of Maintenance Period (up to Week 15) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to the End of Maintenance Period in the Score of Beck Depression Inventory (BDI-II) | The Beck Depression Inventory II (BDI-II) is a self-report instrument to measure Depression symptoms and severity. There are 21 items in the BDI-II. Scores of 0-13 are considered minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; and 29-63 indicates severe depression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 03 | Ansan | South Korea | ||||
| 19 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27322571 | Derived | Chung SJ, Asgharnejad M, Bauer L, Ramirez F, Jeon B. Evaluation of rotigotine transdermal patch for the treatment of depressive symptoms in patients with Parkinson's disease. Expert Opin Pharmacother. 2016 Aug;17(11):1453-61. doi: 10.1080/14656566.2016.1202917. Epub 2016 Jul 7. |
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Participant flow refers to the Randomized Set (RS), consisting of all randomized subjects.
This double-blind, randomized, multicenter, placebo-controlled, in-Patient study started recruiting in April 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotigotine | Rotigotine, daily doses, treatment Group. Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h. Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached. All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days. A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo | Drug | Transdermal Patch Size: 10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2 Subjects randomized to placebo received matching placebo patches |
|
| From Baseline (Week 0) to end of Maintenance Period (up to Week 15) |
| Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living-ADL Subscale) | The UPDRS Part II is a tool to measure Activities in Daily Living - it includes speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism. Each of the 13 questions is measured on a scale from 0 (normal) to 4 (severe). The total score of UPDRS part II ranges from 0 (normal) to 52 (severe). | From Baseline (Week 0) to end of Maintenance Period (up to Week 15) |
| Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale) | Improvement of motor symptoms is measured by the change from Baseline in UPDRS Part III motor score. The UPDRS Part III is an accepted and validated scale for the assessment of motor function in Parkinson's disease. Each of the elements in the UPDRS Part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total score of UPDRS part III ranges from 0 (normal) to 108 (severe abnormalities). | From Baseline (Week 0) to end of Maintenance Period (up to Week 15) |
| Change From Baseline to the End of Maintenance Period in the Combined Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (ADL) Plus Part III (Motor Subscale) | The combined score of UPDRS part II and UPDRS part III is the sum of the individual scores and threfore ranges from 0 (normal) to 160 (severe). | From Baseline (Week 0) to end of Maintenance Period (up to Week 15) |
| Change From Baseline to the End of Maintenance Period in the Score of Apathy Scale (AS) | The AS is an abbreviated version of the Apathy Scale (AS). The AS consists of 14 items phrased as questions that are to be answered on a four-point Likert scale. It was developed specifically for patients with Parkinson Disease (PD). For questions 1-8, the scoring system is the following: not at all = 3 points; slightly = 2 points; some =1 point, a lot = 0 point. For questions 9-14: the scoring system is the following: not at all = 0 points; slightly = 1 point; some = 2 points; a lot = 3 points. Adding all scores provides the final score with a range from 0 to 42. | From Baseline (Week 0) to end of Maintenance Period (up to Week 15) |
| Change From Baseline to the End of Maintenance Period in the Score of Snaith-Hamilton Pleasure Scale (SHAPS) | The SHAPS is a self-report instrument developed for the assessment of hedonic capacity. The sum of the 14 items scores ranges from 0 to 14. A higher score represents more anhedonic symptoms. | From Baseline (Week 0) to end of Maintenance Period (up to Week 15) |
| Anyang |
| South Korea |
| 08 | Busan | South Korea |
| 26 | Busan | South Korea |
| 04 | Daegu | South Korea |
| 05 | Daegu | South Korea |
| 16 | Daejeon | South Korea |
| 28 | Goyang | South Korea |
| 24 | Gwangju | South Korea |
| 29 | Gwangju | South Korea |
| 11 | Gyeonggi-do | South Korea |
| 15 | Jinju | South Korea |
| 01 | Seoul | South Korea |
| 02 | Seoul | South Korea |
| 06 | Seoul | South Korea |
| 07 | Seoul | South Korea |
| 09 | Seoul | South Korea |
| 10 | Seoul | South Korea |
| 12 | Seoul | South Korea |
| 13 | Seoul | South Korea |
| 14 | Seoul | South Korea |
| 17 | Seoul | South Korea |
| 18 | Seoul | South Korea |
| 20 | Seoul | South Korea |
| 21 | Seoul | South Korea |
| 22 | Seoul | South Korea |
| 27 | Seoul | South Korea |
| 23 | Taebuk | South Korea |
| 25 | Yangsan | South Korea |
| FG001 | Placebo | Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches. Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h. Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached. All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days. A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Characteristics refer to the Randomized Set (RS), which consists of all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotigotine | Rotigotine, daily doses, treatment Group. Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h. Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached. All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days. A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration. |
| BG001 | Placebo | Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches. Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h. Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached. All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days. A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration. |
| BG002 | Total Title |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to the End of Maintenance Period in the Score of the Hamilton Depression Scale (HAM-D) | The HAM-D consists of 17 items. Nine of the items are scored on a 5-point scale, ranging from 0 to 4. The remaining 8 items are scored on a 3-point scale, from 0 to 2. Therefore, the total score ranges between 0 to 52, with a cutoff score of 15/16 diagnosing major depressive disorder. | Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | From Baseline (Week 0) to end of Maintenance Period (up to Week 15) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to the End of Maintenance Period in the Score of Beck Depression Inventory (BDI-II) | The Beck Depression Inventory II (BDI-II) is a self-report instrument to measure Depression symptoms and severity. There are 21 items in the BDI-II. Scores of 0-13 are considered minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; and 29-63 indicates severe depression. | Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | From Baseline (Week 0) to end of Maintenance Period (up to Week 15) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living-ADL Subscale) | The UPDRS Part II is a tool to measure Activities in Daily Living - it includes speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism. Each of the 13 questions is measured on a scale from 0 (normal) to 4 (severe). The total score of UPDRS part II ranges from 0 (normal) to 52 (severe). | Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | From Baseline (Week 0) to end of Maintenance Period (up to Week 15) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale) | Improvement of motor symptoms is measured by the change from Baseline in UPDRS Part III motor score. The UPDRS Part III is an accepted and validated scale for the assessment of motor function in Parkinson's disease. Each of the elements in the UPDRS Part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total score of UPDRS part III ranges from 0 (normal) to 108 (severe abnormalities). | Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | From Baseline (Week 0) to end of Maintenance Period (up to Week 15) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to the End of Maintenance Period in the Combined Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (ADL) Plus Part III (Motor Subscale) | The combined score of UPDRS part II and UPDRS part III is the sum of the individual scores and threfore ranges from 0 (normal) to 160 (severe). | Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | From Baseline (Week 0) to end of Maintenance Period (up to Week 15) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to the End of Maintenance Period in the Score of Apathy Scale (AS) | The AS is an abbreviated version of the Apathy Scale (AS). The AS consists of 14 items phrased as questions that are to be answered on a four-point Likert scale. It was developed specifically for patients with Parkinson Disease (PD). For questions 1-8, the scoring system is the following: not at all = 3 points; slightly = 2 points; some =1 point, a lot = 0 point. For questions 9-14: the scoring system is the following: not at all = 0 points; slightly = 1 point; some = 2 points; a lot = 3 points. Adding all scores provides the final score with a range from 0 to 42. | Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | From Baseline (Week 0) to end of Maintenance Period (up to Week 15) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to the End of Maintenance Period in the Score of Snaith-Hamilton Pleasure Scale (SHAPS) | The SHAPS is a self-report instrument developed for the assessment of hedonic capacity. The sum of the 14 items scores ranges from 0 to 14. A higher score represents more anhedonic symptoms. | Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | From Baseline (Week 0) to end of Maintenance Period (up to Week 15) |
|
Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rotigotine | Rotigotine, daily doses, treatment Group. Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h. Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached. All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days. A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration. | 6 | 184 | 112 | 184 | ||
| EG001 | Placebo | Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches. Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h. Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached. All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days. A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration. | 14 | 196 | 91 | 196 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Spondylolisthesis | Congenital, familial and genetic disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Kidney transplant rejection | Immune system disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA9.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA9.1 | Non-systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA9.1 | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA9.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA9.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Cervix carcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA9.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA9.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA9.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA9.1 | Non-systematic Assessment |
|
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | UCB | +1877 822 9493 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003863 | Depression |
| 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 |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| C047508 | rotigotine |
Not provided
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| >18-<65 years |
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| >=65 years |
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| Male |
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| Units | Counts |
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