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Patients with advanced Parkinson's Disease experience a range in the severity of their motor fluctuations. The rationale for this Post Marketing Observational Study is to demonstrate the benefits of Duodopa treatment on Parkinson's Disease patients entering the advanced stage of the disease whose motor fluctuations have become troublesome and complicate management with oral therapy. The aim of this post-marketing observational study is to assess the effect of Duodopa treatment on activities of daily living in advanced Parkinson's Disease participants characterised by either 2-4 hours of "off" time or 2 hours of non-troublesome or troublesome dyskinesia daily, supported by a Unified Parkinson's Disease Rating Scale Total Score in the best "on" state of at least 40 points at baseline.
Data are recorded from visits most closely aligned with the planned periods of Visit 0 (V0): Baseline (After decision to use the temporary naso-duodenal tube (approximately 2-14 days) and after signature of the Patient Authorization/Informed Consent Form); Visit 1 (V1): At discharge from hospital; Visit 2 (V2): 3 months after discharge; Visit 3 (V3): 6 months after discharge; Visit 4 (V4): 12 months after discharge.
All participants have a temporary naso-duodenal tube used initially with the infusion pump to determine if the participant responds favorably to this method of treatment and to optimize the dose of Duodopa before permanent treatment is started.
Participants who choose a treatment other than Duodopa after the temporary naso-duodenal test phase are considered for the Standard of Care group. Participants who go on to select Apomorphine pump or Deep Brain Stimulation at any stage are not eligible to continue in this group or to continue in the observational period of study.
Participants who continue to with Duodopa treatment after the the temporary naso-duodenal test phase are the Duodopa group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duodopa | Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J) | ||
| Standard of Care | Participants that return to oral or transdermal anti-parkinson's disease medications |
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| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 12 Months After Hospital Discharge | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to 13 questions, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. UPDRS scores during "On" time (when PD symptoms are well controlled by the drug) are presented. Last observation carried forward (LOCF) was used for missing data. | Baseline (Week 0) and 12 months after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to 13 questions, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. UPDRS scores during "On" time (when PD symptoms are well controlled by the drug) are presented. n=the number of participants with data at baseline and given time point. |
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Inclusion Criteria:
Exclusion Criteria:
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Hospital clinic
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| Name | Affiliation | Role |
|---|---|---|
| Koray Onuk, MD | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Duodopa | Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J) |
| FG001 | Standard of Care |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Temporary Naso-jejunal Tube Period |
|
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| Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
| Percentage of Participants Who Continued With Jejunal Extension Tube of the Percutaneous Endoscopic Gastrostomy (PEG-J) Treatment | The percentage of participants who continued with PEG-J treatment after treatment via temporary naso-jejunal tube. | 14 days |
| Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study | The primary reasons for stopping treatment with Duodopa or for discontinuing the study. | 12 months |
| Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 32 (Duration) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of "off" times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point. | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
| Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 33 (Disability) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of "off" times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point. | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
| Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 34 (Pain) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of "off" times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point. | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
| Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Clinical Fluctuations) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of "off" times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point. | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
| Unified Parkinson's Disease Rating Scale (UPDRS) III (Motor Examination) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | The UPDRS III questionnaire consists of 14 questions on motor examinations rated from 0 (absent/normal) to 4 (extreme impairment). Questions 20-26 are multi-part questions in that they are evaluated separately for multiple body parts (for example, for the left and right hand). Counting each of these assessments leads to a total of 27 answers. The UPDRS III score ranges from 0 to 108 with higher values indicating greater impairment and was calculated as the sum of the 27 answers provided to the 14 questions. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point. | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
| Non-Motor Symptoms Assessment Scale for Parkinson's Disease (NMSS Rating Scale) Total Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | Non-motor symptoms assessed over the previous month were scored with respect to severity (0 = none, 1 = mild, 2 = moderate, 3 = severe) and with respect to frequency (1 = rarely, 2 = often, 3 = frequent, 4 = very frequent). The total NMSS score ranges from 0 to 360 with higher values indicating greater impairment and was calculated as the sum of all individual score values. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point. | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
| Parkinson's Disease Quality of Life Questionnaire (PDQ-8) Summary Index Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | Participants were asked to state how often they had encountered certain problems over the past four weeks using the following rating scale: Never (0), occasionally (1), sometimes (2), often (3), always or cannot do at all (4). The PDQ-8 summary index was derived as the sum of the single items divided by 32. Scores range from 0 to 100. A higher summary index score indicates a higher impairment of quality of life. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point. | Baseline (Week 0), at discharge from hospital, and 3, 6, and 12 months after hospital discharge |
| Healthcare Resource Utilization (HCRU) Number of Office Visits: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point. | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
| Healthcare Resource Utilization (HCRU) Number of Visits at Home: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point. | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
| Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge | Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at given time point. | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
| Healthcare Resource Utilization (HCRU) Received Assistance at Home: Percentage of Participants Who Received Assistance at Home at 3, 6, and 12 Months After Hospital Discharge | Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at given time point. | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
| Healthcare Resource Utilization (HCRU) Falls: Percentage of Participants With Falls at 3, 6, and 12 Months After Hospital Discharge | Participants were asked about their utilization of healthcare resources within the previous 3 months , including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point. | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
Participants that return to oral or transdermal anti-Parkinson's Disease medications
| COMPLETED |
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| NOT COMPLETED |
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| PEG-J Period (Duodopa Treatment) |
|
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| PEG-J Period (Continued Treatment) |
|
All subjects in the MAS
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| ID | Title | Description |
|---|---|---|
| BG000 | Duodopa | Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 12 Months After Hospital Discharge | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to 13 questions, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. UPDRS scores during "On" time (when PD symptoms are well controlled by the drug) are presented. Last observation carried forward (LOCF) was used for missing data. | MAS population | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0) and 12 months after hospital discharge |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to 13 questions, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. UPDRS scores during "On" time (when PD symptoms are well controlled by the drug) are presented. n=the number of participants with data at baseline and given time point. | MAS population | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Continued With Jejunal Extension Tube of the Percutaneous Endoscopic Gastrostomy (PEG-J) Treatment | The percentage of participants who continued with PEG-J treatment after treatment via temporary naso-jejunal tube. | MAS population | Posted | Number | percentage of participants | 14 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study | The primary reasons for stopping treatment with Duodopa or for discontinuing the study. | Participants in the MAS who stopped treatment with Duodopa or discontinued from study. | Posted | Number | participants | 12 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 32 (Duration) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of "off" times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point. | MAS population | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
|
| |||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 33 (Disability) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of "off" times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point. | MAS population | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
|
| |||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 34 (Pain) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of "off" times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point. | MAS population | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
|
| |||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Clinical Fluctuations) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of "off" times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point. | MAS population | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
|
| |||||||||||||||||||||||||||||
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS) III (Motor Examination) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | The UPDRS III questionnaire consists of 14 questions on motor examinations rated from 0 (absent/normal) to 4 (extreme impairment). Questions 20-26 are multi-part questions in that they are evaluated separately for multiple body parts (for example, for the left and right hand). Counting each of these assessments leads to a total of 27 answers. The UPDRS III score ranges from 0 to 108 with higher values indicating greater impairment and was calculated as the sum of the 27 answers provided to the 14 questions. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point. | MAS population | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
| ||||||||||||||||||||||||||||||
| Secondary | Non-Motor Symptoms Assessment Scale for Parkinson's Disease (NMSS Rating Scale) Total Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | Non-motor symptoms assessed over the previous month were scored with respect to severity (0 = none, 1 = mild, 2 = moderate, 3 = severe) and with respect to frequency (1 = rarely, 2 = often, 3 = frequent, 4 = very frequent). The total NMSS score ranges from 0 to 360 with higher values indicating greater impairment and was calculated as the sum of all individual score values. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point. | MAS population | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
|
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| Secondary | Parkinson's Disease Quality of Life Questionnaire (PDQ-8) Summary Index Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | Participants were asked to state how often they had encountered certain problems over the past four weeks using the following rating scale: Never (0), occasionally (1), sometimes (2), often (3), always or cannot do at all (4). The PDQ-8 summary index was derived as the sum of the single items divided by 32. Scores range from 0 to 100. A higher summary index score indicates a higher impairment of quality of life. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point. | MAS population | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0), at discharge from hospital, and 3, 6, and 12 months after hospital discharge |
| ||||||||||||||||||||||||||||||
| Secondary | Healthcare Resource Utilization (HCRU) Number of Office Visits: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point. | MAS population | Posted | Mean | Standard Deviation | office visits | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
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| Secondary | Healthcare Resource Utilization (HCRU) Number of Visits at Home: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge | Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point. | MAS population | Posted | Mean | Standard Deviation | visits at home | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
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| Secondary | Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge | Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at given time point. | MAS population | Posted | Number | percentage of participants | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
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| Secondary | Healthcare Resource Utilization (HCRU) Received Assistance at Home: Percentage of Participants Who Received Assistance at Home at 3, 6, and 12 Months After Hospital Discharge | Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at given time point. | MAS population | Posted | Number | percentage of participants | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
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| Secondary | Healthcare Resource Utilization (HCRU) Falls: Percentage of Participants With Falls at 3, 6, and 12 Months After Hospital Discharge | Participants were asked about their utilization of healthcare resources within the previous 3 months , including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point. | MAS population | Posted | Number | percentage of participants | Baseline (Week 0) and 3, 6, and 12 months after hospital discharge |
|
|
All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Duodopa | Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy | 14 | 64 | 10 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CARDIAC FAILURE | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| MELAENA | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| SUDDEN DEATH | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| PERITONITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| STOMA SITE INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| FASCIITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| BASILAR ARTERY THROMBOSIS | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| COGNITIVE DISORDER | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DYSTONIA | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| HYPOGLYCAEMIC COMA | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| MOTOR DYSFUNCTION | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| SPASMODIC DYSPHONIA | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| ABNORMAL DREAMS | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DOPAMINE DYSREGULATION SYNDROME | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| POLYURIA | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
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| RESPIRATORY ARREST | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| PALLOR | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| CATHETER SITE HAEMATOMA | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DEVICE DISLOCATION | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| STOMA SITE INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| STOMA SITE DISCHARGE | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| STOMA SITE GRANULOMA | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| READING DISORDER | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| THERAPY CESSATION | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
Results for the SoC group should be interpreted with care due to the small number of patients. Also, when comparing the SoC and Duodopa groups one should be aware that patients of the SoC group may have had Duodopa treatment before returning to SoC.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie | 1-800-633-9110 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| 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 |
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