Trial Outcomes & Findings for A Post Marketing Observational Study of Activities of Daily Living in Advanced Parkinson's Disease Patients With Early Troublesome Motor Fluctuations and Treated With Duodopa - a Multi-country Study (NCT NCT01747655)
NCT ID: NCT01747655
Last Updated: 2016-10-13
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
64 participants
Primary outcome timeframe
Baseline (Week 0) and 12 months after hospital discharge
Results posted on
2016-10-13
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Temporary Naso-jejunal Tube Period
STARTED
|
64
|
0
|
|
Temporary Naso-jejunal Tube Period
COMPLETED
|
64
|
0
|
|
Temporary Naso-jejunal Tube Period
NOT COMPLETED
|
0
|
0
|
|
PEG-J Period (Duodopa Treatment)
STARTED
|
58
|
6
|
|
PEG-J Period (Duodopa Treatment)
COMPLETED
|
44
|
6
|
|
PEG-J Period (Duodopa Treatment)
NOT COMPLETED
|
14
|
0
|
|
PEG-J Period (Continued Treatment)
STARTED
|
41
|
15
|
|
PEG-J Period (Continued Treatment)
COMPLETED
|
41
|
15
|
|
PEG-J Period (Continued Treatment)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
PEG-J Period (Duodopa Treatment)
Investigator Decision (Medical Event)
|
5
|
0
|
|
PEG-J Period (Duodopa Treatment)
Patient Decision
|
8
|
0
|
|
PEG-J Period (Duodopa Treatment)
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Post Marketing Observational Study of Activities of Daily Living in Advanced Parkinson's Disease Patients With Early Troublesome Motor Fluctuations and Treated With Duodopa - a Multi-country Study
Baseline characteristics by cohort
| Measure |
Duodopa
n=64 Participants
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)
|
|---|---|
|
Age, Continuous
|
70.4 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and 12 months after hospital dischargePopulation: MAS population
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.
Outcome measures
| Measure |
Duodopa
n=47 Participants
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
n=14 Participants
Participants that return to oral or transdermal anti-Parkinson's Disease medications
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 12 Months After Hospital Discharge
|
-2.1 units on a scale
Standard Deviation 6.9
|
1.4 units on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and 3, 6, and 12 months after hospital dischargePopulation: MAS population
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.
Outcome measures
| Measure |
Duodopa
n=58 Participants
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
n=15 Participants
Participants that return to oral or transdermal anti-Parkinson's Disease medications
|
|---|---|---|
|
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
Change from baseline to 3 months (n=47,7)
|
-4.4 units on a scale
Standard Deviation 5.6
|
0.9 units on a scale
Standard Deviation 6.0
|
|
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
Change from baseline to 6 months (n=44,6)
|
-3.4 units on a scale
Standard Deviation 4.9
|
-1.5 units on a scale
Standard Deviation 2.3
|
|
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
Change from baseline to 12 months (n=41,6)
|
-1.8 units on a scale
Standard Deviation 7.1
|
0.5 units on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: 14 daysPopulation: MAS population
The percentage of participants who continued with PEG-J treatment after treatment via temporary naso-jejunal tube.
Outcome measures
| Measure |
Duodopa
n=64 Participants
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
|
|---|---|---|
|
Percentage of Participants Who Continued With Jejunal Extension Tube of the Percutaneous Endoscopic Gastrostomy (PEG-J) Treatment
|
90.6 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants in the MAS who stopped treatment with Duodopa or discontinued from study.
The primary reasons for stopping treatment with Duodopa or for discontinuing the study.
Outcome measures
| Measure |
Duodopa
n=23 Participants
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
|
|---|---|---|
|
Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study
Patient decision
|
9 participants
|
—
|
|
Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study
Investigator decision (due to medical event)
|
8 participants
|
—
|
|
Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study
Investigator decision (other than medical event)
|
2 participants
|
—
|
|
Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study
Does not feel has adequate support after discharge
|
1 participants
|
—
|
|
Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study
Does not wish to carry the pump / device system
|
1 participants
|
—
|
|
Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study
Does not wish to undergo the PEG-J procedure
|
1 participants
|
—
|
|
Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study
Lost to follow-up
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and 3, 6, and 12 months after hospital dischargePopulation: MAS population
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.
Outcome measures
| Measure |
Duodopa
n=58 Participants
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
n=15 Participants
Participants that return to oral or transdermal anti-Parkinson's Disease medications
|
|---|---|---|
|
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
Change from baseline to 3 months (n=47,6)
|
-0.5 units on a scale
Standard Deviation 1.1
|
-0.5 units on a scale
Standard Deviation 0.8
|
|
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
Change from baseline to 6 months after (n=44,6)
|
-0.6 units on a scale
Standard Deviation 1.0
|
-0.5 units on a scale
Standard Deviation 1.0
|
|
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
Change from baseline to 12 months (n=41,6)
|
-0.4 units on a scale
Standard Deviation 1.2
|
-0.2 units on a scale
Standard Deviation 1.2
|
|
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
Change from baseline to 12 months LOCF (n=47,14)
|
-0.5 units on a scale
Standard Deviation 1.2
|
-0.4 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and 3, 6, and 12 months after hospital dischargePopulation: MAS population
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.
Outcome measures
| Measure |
Duodopa
n=58 Participants
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
n=15 Participants
Participants that return to oral or transdermal anti-Parkinson's Disease medications
|
|---|---|---|
|
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
Change from baseline to 3 months (n=47,6)
|
-0.9 units on a scale
Standard Deviation 0.9
|
-0.3 units on a scale
Standard Deviation 0.5
|
|
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
Change from baseline to 6 months (n=44,6)
|
-0.9 units on a scale
Standard Deviation 1.0
|
-0.3 units on a scale
Standard Deviation 0.5
|
|
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
Change from baseline to 12 months (n=41,6)
|
-0.5 units on a scale
Standard Deviation 1.1
|
-0.5 units on a scale
Standard Deviation 1.4
|
|
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
Change from baseline to 12 months LOCF (n=47,14)
|
-0.9 units on a scale
Standard Deviation 1.1
|
-0.6 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and 3, 6, and 12 months after hospital dischargePopulation: MAS population
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.
Outcome measures
| Measure |
Duodopa
n=58 Participants
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
n=15 Participants
Participants that return to oral or transdermal anti-Parkinson's Disease medications
|
|---|---|---|
|
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
Change from baseline to 12 months LOCF (n=47,14)
|
-0.3 units on a scale
Standard Deviation 0.8
|
0.0 units on a scale
Standard Deviation 0.9
|
|
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
Change from baseline to 3 months (n=47,6)
|
-0.3 units on a scale
Standard Deviation 0.8
|
0.2 units on a scale
Standard Deviation 0.4
|
|
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
Change from baseline to 6 months (n=43,6)
|
-0.3 units on a scale
Standard Deviation 0.8
|
-0.3 units on a scale
Standard Deviation 0.8
|
|
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
Change from baseline to 12 months (n=41,6)
|
-0.3 units on a scale
Standard Deviation 0.7
|
0.3 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and 3, 6, and 12 months after hospital dischargePopulation: MAS population
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.
Outcome measures
| Measure |
Duodopa
n=58 Participants
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
n=15 Participants
Participants that return to oral or transdermal anti-Parkinson's Disease medications
|
|---|---|---|
|
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
Change from baseline to 3 months (n=47,6)
|
-0.9 units on a scale
Standard Deviation 1.0
|
-0.5 units on a scale
Standard Deviation 1.5
|
|
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
Change from baseline to 6 months (n=44,6
|
-0.9 units on a scale
Standard Deviation 0.9
|
-0.7 units on a scale
Standard Deviation 0.5
|
|
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
Change from baseline to 12 months (n=41,6)
|
-0.8 units on a scale
Standard Deviation 0.8
|
-0.3 units on a scale
Standard Deviation 1.0
|
|
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
Change from baseline to 12 months LOCF (n=47,14)
|
-0.8 units on a scale
Standard Deviation 0.9
|
-0.4 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and 3, 6, and 12 months after hospital dischargePopulation: MAS population
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.
Outcome measures
| Measure |
Duodopa
n=58 Participants
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
n=15 Participants
Participants that return to oral or transdermal anti-Parkinson's Disease medications
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) III (Motor Examination) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Change from baseline to 3 months (n=51)
|
-12.9 units on a scale
Standard Deviation 16.2
|
-6.3 units on a scale
Standard Deviation 11.9
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) III (Motor Examination) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Change from baseline to 6 months (n=49)
|
-8.9 units on a scale
Standard Deviation 12.3
|
-17.0 units on a scale
Standard Deviation 22.6
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) III (Motor Examination) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Change from baseline to 12 months (n=46)
|
-8.7 units on a scale
Standard Deviation 12.6
|
0.3 units on a scale
Standard Deviation 16.5
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) III (Motor Examination) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Change from baseline to 12 months LOCF (n=61)
|
-8.9 units on a scale
Standard Deviation 12.6
|
-8.7 units on a scale
Standard Deviation 21.2
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and 3, 6, and 12 months after hospital dischargePopulation: MAS population
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.
Outcome measures
| Measure |
Duodopa
n=58 Participants
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
n=15 Participants
Participants that return to oral or transdermal anti-Parkinson's Disease medications
|
|---|---|---|
|
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
Change from baseline to 3 months (n=44,5)
|
-39.5 units on a scale
Standard Deviation 38.0
|
-8.0 units on a scale
Standard Deviation 14.6
|
|
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
Change from baseline to 6 months (n=40,5)
|
-33.7 units on a scale
Standard Deviation 33.1
|
-45.0 units on a scale
Standard Deviation 64.5
|
|
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
Change from baseline to 12 months (n=38,6)
|
-33.9 units on a scale
Standard Deviation 40.6
|
-10.3 units on a scale
Standard Deviation 15.2
|
|
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
Change from baseline to 12 months LOCF (n=40,10)
|
-32.5 units on a scale
Standard Deviation 40.1
|
-32.7 units on a scale
Standard Deviation 45.9
|
SECONDARY outcome
Timeframe: Baseline (Week 0), at discharge from hospital, and 3, 6, and 12 months after hospital dischargePopulation: MAS population
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.
Outcome measures
| Measure |
Duodopa
n=58 Participants
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
n=15 Participants
Participants that return to oral or transdermal anti-Parkinson's Disease medications
|
|---|---|---|
|
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
3 months after discharge (n=46,6)
|
-15.7 units on a scale
Standard Deviation 17.8
|
-2.6 units on a scale
Standard Deviation 6.4
|
|
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
6 months after discharge (n=43,6)
|
-15.4 units on a scale
Standard Deviation 17.2
|
-10.9 units on a scale
Standard Deviation 20.3
|
|
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
12 months after discharge (n=41,6)
|
-12.3 units on a scale
Standard Deviation 20.6
|
-3.6 units on a scale
Standard Deviation 7.5
|
|
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
12 months after discharge LOCF (n=42,10)
|
-12.1 units on a scale
Standard Deviation 20.4
|
-8.1 units on a scale
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and 3, 6, and 12 months after hospital dischargePopulation: MAS population
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.
Outcome measures
| Measure |
Duodopa
n=64 Participants
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
|
|---|---|---|
|
Healthcare Resource Utilization (HCRU) Number of Office Visits: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Baseline (n=64)
|
8.7 office visits
Standard Deviation 9.8
|
—
|
|
Healthcare Resource Utilization (HCRU) Number of Office Visits: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Change from baseline to 3 months (n=53)
|
-3.0 office visits
Standard Deviation 8.0
|
—
|
|
Healthcare Resource Utilization (HCRU) Number of Office Visits: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Change from baseline to 6 months (n=49)
|
-2.7 office visits
Standard Deviation 9.8
|
—
|
|
Healthcare Resource Utilization (HCRU) Number of Office Visits: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Change from baseline to 12 months (n=47)
|
-2.1 office visits
Standard Deviation 18.5
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and 3, 6, and 12 months after hospital dischargePopulation: MAS population
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.
Outcome measures
| Measure |
Duodopa
n=64 Participants
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
|
|---|---|---|
|
Healthcare Resource Utilization (HCRU) Number of Visits at Home: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Baseline (n=64)
|
11.2 visits at home
Standard Deviation 31.4
|
—
|
|
Healthcare Resource Utilization (HCRU) Number of Visits at Home: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Change from baseline to 3 months (n=53)
|
0.8 visits at home
Standard Deviation 25.8
|
—
|
|
Healthcare Resource Utilization (HCRU) Number of Visits at Home: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Change from baseline to 6 months (n=49)
|
-1.0 visits at home
Standard Deviation 21.5
|
—
|
|
Healthcare Resource Utilization (HCRU) Number of Visits at Home: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
Change from baseline to 12 months (n=47)
|
4.0 visits at home
Standard Deviation 31.5
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and 3, 6, and 12 months after hospital dischargePopulation: MAS population
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.
Outcome measures
| Measure |
Duodopa
n=64 Participants
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
|
|---|---|---|
|
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
Calls for immediate assistance at 3 months (n=53)
|
26.4 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
Overnight hospital stay at Baseline (n=64)
|
14.1 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
Overnight hospital stay at 3 months (n=53)
|
9.4 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
Overnight hospital stay at 6 months (n=49)
|
10.2 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
Overnight hospital stay at 12 months (n=47)
|
6.4 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
Visit at emergency room at Baseline (n=64)
|
10.9 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
Visit at emergency room at 3 months (n=53)
|
3.8 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
Visit at emergency room at 6 months (n=49)
|
14.3 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
Visit at emergency room at 12 months (n=47)
|
8.5 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
Calls for immediate assistance at Baseline (n=64)
|
25.0 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
Calls for immediate assistance at 6 months (n=49)
|
6.1 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
Calls for immediate assistance at 12 months (n=46)
|
4.3 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
911/Emergency at Baseline (n=64)
|
4.7 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
911/Emergency at 3 months (n=53)
|
1.9 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
911/Emergency at 6 months (n=49)
|
4.1 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
911/Emergency at 12 months (n=46)
|
4.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and 3, 6, and 12 months after hospital dischargePopulation: MAS population
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.
Outcome measures
| Measure |
Duodopa
n=64 Participants
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
|
|---|---|---|
|
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
Family/friend at Baseline (n=64)
|
59.4 percentage of participants
|
—
|
|
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
Family/friend at 3 months (n=53)
|
49.1 percentage of participants
|
—
|
|
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
Family/friend at 6 months (n=49)
|
44.9 percentage of participants
|
—
|
|
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
Family/friend at 12 months (n=47)
|
46.8 percentage of participants
|
—
|
|
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
Paid caregiver at Baseline (n=64)
|
10.9 percentage of participants
|
—
|
|
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
Paid caregiver at 3 months (n=53)
|
24.5 percentage of participants
|
—
|
|
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
Paid caregiver at 6 months (n=49)
|
24.5 percentage of participants
|
—
|
|
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
Paid caregiver at 12 months (n=47)
|
25.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and 3, 6, and 12 months after hospital dischargePopulation: MAS population
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.
Outcome measures
| Measure |
Duodopa
n=64 Participants
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
|
|---|---|---|
|
Healthcare Resource Utilization (HCRU) Falls: Percentage of Participants With Falls at 3, 6, and 12 Months After Hospital Discharge
Baseline (n=64)
|
35.9 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Falls: Percentage of Participants With Falls at 3, 6, and 12 Months After Hospital Discharge
3 months (n=53)
|
17.0 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Falls: Percentage of Participants With Falls at 3, 6, and 12 Months After Hospital Discharge
6 months (n=49)
|
24.5 percentage of participants
|
—
|
|
Healthcare Resource Utilization (HCRU) Falls: Percentage of Participants With Falls at 3, 6, and 12 Months After Hospital Discharge
12 months (n=47)
|
14.9 percentage of participants
|
—
|
Adverse Events
Duodopa
Serious events: 14 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Duodopa
n=64 participants at risk
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
|
|---|---|
|
Cardiac disorders
CARDIAC FAILURE
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Gastrointestinal disorders
DYSPHAGIA
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Gastrointestinal disorders
MELAENA
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
General disorders
GAIT DISTURBANCE
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
General disorders
PYREXIA
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
General disorders
SUDDEN DEATH
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Infections and infestations
LUNG INFECTION
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Infections and infestations
PERITONITIS
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Infections and infestations
PNEUMONIA
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Infections and infestations
STOMA SITE INFECTION
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Musculoskeletal and connective tissue disorders
FASCIITIS
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Nervous system disorders
BASILAR ARTERY THROMBOSIS
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Nervous system disorders
COGNITIVE DISORDER
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Nervous system disorders
DYSTONIA
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Nervous system disorders
HYPOGLYCAEMIC COMA
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Nervous system disorders
MOTOR DYSFUNCTION
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Nervous system disorders
SPASMODIC DYSPHONIA
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Nervous system disorders
TREMOR
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Psychiatric disorders
ABNORMAL DREAMS
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Psychiatric disorders
DEPRESSION
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Psychiatric disorders
DOPAMINE DYSREGULATION SYNDROME
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
3.1%
2/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Renal and urinary disorders
POLYURIA
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Vascular disorders
HYPOTENSION
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Vascular disorders
PALLOR
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
Other adverse events
| Measure |
Duodopa
n=64 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Gastrointestinal disorders
VOMITING
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
General disorders
CATHETER SITE HAEMATOMA
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
General disorders
DEVICE DISLOCATION
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Infections and infestations
CELLULITIS
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Infections and infestations
STOMA SITE INFECTION
|
3.1%
2/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Injury, poisoning and procedural complications
STOMA SITE DISCHARGE
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Injury, poisoning and procedural complications
STOMA SITE GRANULOMA
|
3.1%
2/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Investigations
WEIGHT DECREASED
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Psychiatric disorders
READING DISORDER
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Surgical and medical procedures
THERAPY CESSATION
|
4.7%
3/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
1.6%
1/64 • All adverse events were collected from Baseline (Week 0) to 12 months after discharge (up to 13 months).
|
Additional Information
Global Medical Information
AbbVie
Phone: 1-800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER