Trial Outcomes & Findings for Global REsponsE During iNFusIon of a gEl With LevoDopa/Carbidopa (NCT NCT01754129)
NCT ID: NCT01754129
Last Updated: 2018-08-10
Results Overview
Section B of the UPDRS IV questionnaire consists of 4 individual items that assess the degree of clinical fluctuations. Item 39 is the percentage of "off" times (when PD symptoms are not adequately controlled by the drug) during the waking day. The Item 39 score ranges from 0 (None), 1 (1- 25% of the waking day), 2 (26 - 50% of the waking day), 3 (51 - 75% of the waking day), and 4 (76 - 100% of the waking day). The mean change from baseline was calculated as the score at the last available follow up visit minus the score at baseline/Visit 1. Negative change from baseline for "off" time indicates improvement.
Recruitment status
COMPLETED
Target enrollment
148 participants
Primary outcome timeframe
Baseline/Visit 1 and Visit 2 (Year 1) or Visit 3 (Year 2)
Results posted on
2018-08-10
Participant Flow
Screened population: all participants who were screened for the study
Participant milestones
| Measure |
Participants With Parkinson's Disease
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
|---|---|
|
Overall Study
STARTED
|
148
|
|
Overall Study
Visit 1 (Enrollment Day)
|
145
|
|
Overall Study
Visit 2 (Year 1)
|
129
|
|
Overall Study
Visit 3 (Year 2)
|
115
|
|
Overall Study
COMPLETED
|
115
|
|
Overall Study
NOT COMPLETED
|
33
|
Reasons for withdrawal
| Measure |
Participants With Parkinson's Disease
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
|---|---|
|
Overall Study
Death
|
13
|
|
Overall Study
Duodopa discontinuation
|
9
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Withdrew consent
|
1
|
|
Overall Study
Inclusion/exclusion criteria violation
|
3
|
Baseline Characteristics
Global REsponsE During iNFusIon of a gEl With LevoDopa/Carbidopa
Baseline characteristics by cohort
| Measure |
Participants With Parkinson's Disease
n=145 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
|---|---|
|
Age, Continuous
|
70.4 years
STANDARD_DEVIATION 7.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
|
Time since Parkinson's disease diagnosis
|
14.7 years
STANDARD_DEVIATION 6.46 • n=5 Participants
|
|
Time since onset of Parkinson's disease motor fluctuations
|
5.9 years
STANDARD_DEVIATION 3.94 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline/Visit 1 and Visit 2 (Year 1) or Visit 3 (Year 2)Population: Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.
Section B of the UPDRS IV questionnaire consists of 4 individual items that assess the degree of clinical fluctuations. Item 39 is the percentage of "off" times (when PD symptoms are not adequately controlled by the drug) during the waking day. The Item 39 score ranges from 0 (None), 1 (1- 25% of the waking day), 2 (26 - 50% of the waking day), 3 (51 - 75% of the waking day), and 4 (76 - 100% of the waking day). The mean change from baseline was calculated as the score at the last available follow up visit minus the score at baseline/Visit 1. Negative change from baseline for "off" time indicates improvement.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=135 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Participants With Parkinson's Disease- Visit 2
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
|---|---|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Proportion of Waking Day Spent in "Off") Score: Mean Change From Baseline to the Last Available Follow up
Change from baseline to Visit 3
|
-0.97 units on a scale
Interval -1.15 to -0.79
|
—
|
—
|
—
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Proportion of Waking Day Spent in "Off") Score: Mean Change From Baseline to the Last Available Follow up
Change from baseline to Visit 2
|
-1.04 units on a scale
Interval -1.23 to -0.85
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)Population: Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.
The UPDRS is an Investigator-used rating tool to follow the course of Parkinson's disease. Scores for dyskinesias, early-morning dystonia, and clinical fluctuations ("off" times when PD symptoms are not adequately controlled by the drug) were assessed by the sum of the Part A+B items, questions 32-39. Questions 32-34 and 39 are measured on a 5-point scale (0-4), with 0 being no disease and 4 representing severe disease. Higher scores indicate a greater duration of dyskinesia (Q32), disability (Q33), and pain (Q34), and proportion of the waking day spent in "off" (Q39). Questions 35-38 are scored on a binary scale where 0= no and 1=yes, with higher scores indicating a higher incidence of early morning dystonia, and a higher degree of clinical fluctuations. The total score ranges from 0 (normal) to 20 (severe disease). Negative changes from baseline indicate improvement.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=134 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Participants With Parkinson's Disease- Visit 2
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
|---|---|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Part A+B Score: Mean Change From Baseline to Visits 2 and 3
Change from baseline to Visit 2
|
-3.33 units on a scale
Interval -4.01 to -2.65
|
—
|
—
|
—
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Part A+B Score: Mean Change From Baseline to Visits 2 and 3
Change from baseline to Visit 3
|
-3.08 units on a scale
Interval -3.72 to -2.43
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)Population: Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.
The UPDRS is an Investigator-used rating tool to follow the course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0 to 16 and higher scores are associated with more disability. The Part II score is the sum of the answers to the 13 questions that comprise Part II, 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. Scores for both "On" time (when PD symptoms are well-controlled by the drug) and "Off" time (when PD symptoms are not adequately controlled by the drug) are presented. Negative changes from baseline indicate improvement.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=129 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Participants With Parkinson's Disease- Visit 2
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
|---|---|---|---|---|
|
Change in Unified Parkinson's Disease Rating Scale on Mentation, Behavior and Mood (UPDRS I) and Activities of Daily Living (UPDRS II) During On and Off Phases
UPDRS I "On" Change from baseline to Visit 2
|
-0.49 units on a scale
Interval -1.06 to 0.08
|
—
|
—
|
—
|
|
Change in Unified Parkinson's Disease Rating Scale on Mentation, Behavior and Mood (UPDRS I) and Activities of Daily Living (UPDRS II) During On and Off Phases
UPDRS I "On" Change from baseline to Visit 3
|
-0.21 units on a scale
Interval -0.81 to 0.38
|
—
|
—
|
—
|
|
Change in Unified Parkinson's Disease Rating Scale on Mentation, Behavior and Mood (UPDRS I) and Activities of Daily Living (UPDRS II) During On and Off Phases
UPDRS I "Off" Change from baseline to Visit 2
|
-0.83 units on a scale
Interval -1.68 to 0.01
|
—
|
—
|
—
|
|
Change in Unified Parkinson's Disease Rating Scale on Mentation, Behavior and Mood (UPDRS I) and Activities of Daily Living (UPDRS II) During On and Off Phases
UPDRS I "Off" Change from baseline to Visit 3
|
-0.92 units on a scale
Interval -1.85 to 0.02
|
—
|
—
|
—
|
|
Change in Unified Parkinson's Disease Rating Scale on Mentation, Behavior and Mood (UPDRS I) and Activities of Daily Living (UPDRS II) During On and Off Phases
UPDRS II "On" Change from baseline to Visit 2
|
-2.42 units on a scale
Interval -3.98 to -0.86
|
—
|
—
|
—
|
|
Change in Unified Parkinson's Disease Rating Scale on Mentation, Behavior and Mood (UPDRS I) and Activities of Daily Living (UPDRS II) During On and Off Phases
UPDRS II "On" Change from baseline to Visit 3
|
-1.48 units on a scale
Interval -3.14 to 0.17
|
—
|
—
|
—
|
|
Change in Unified Parkinson's Disease Rating Scale on Mentation, Behavior and Mood (UPDRS I) and Activities of Daily Living (UPDRS II) During On and Off Phases
UPDRS II "Off" Change from baseline to Visit 2
|
-3.79 units on a scale
Interval -5.66 to -1.92
|
—
|
—
|
—
|
|
Change in Unified Parkinson's Disease Rating Scale on Mentation, Behavior and Mood (UPDRS I) and Activities of Daily Living (UPDRS II) During On and Off Phases
UPDRS II "Off" Change from baseline to Visit 3
|
-3.10 units on a scale
Interval -5.08 to -1.12
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)Population: Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.
The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in PD. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The total score is between 0 and 156, calculated as the total sum of the items, and higher scores are associated with more severe symptoms. Negative changes from baseline indicate improvement.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=136 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Participants With Parkinson's Disease- Visit 2
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
|---|---|---|---|---|
|
Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) Scores
Change from baseline to Visit 2
|
-2.70 units on a scale
Interval -6.03 to 0.64
|
—
|
—
|
—
|
|
Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) Scores
Change from baseline to Visit 3
|
-0.09 units on a scale
Interval -3.28 to 3.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)Population: Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.
The Parkinson's Disease Sleep Scale version 2 (PDSS-2) is a self-administered 15-item questionnaire addressing sleep and nocturnal disturbances in PD, including sleep quality, difficulty falling and staying asleep, restlessness, pain, or muscle cramps in legs or arms, dreams or hallucinations, getting up at night to pass urine, immobility at night, painful posturing in the morning, tremor on waking, sleepiness upon waking, and snoring or breathing difficulties. Scores on each item range from 0 (never) to 4 (very frequent). The PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance). Negative changes from baseline indicate improvement.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=135 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Participants With Parkinson's Disease- Visit 2
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
|---|---|---|---|---|
|
Change in Parkinson's Disease Sleep Scale Version 2 (PDSS-2) Scores
Change from baseline to Visit 2
|
-1.19 units on a scale
Interval -2.59 to 0.2
|
—
|
—
|
—
|
|
Change in Parkinson's Disease Sleep Scale Version 2 (PDSS-2) Scores
Change from baseline to Visit 3
|
-0.95 units on a scale
Interval -2.61 to 0.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)Population: Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.
The Gait and Falls questionnaire (GFQ) is a self-administered 16-item questionnaire addressing gait in daily living, the frequency and severity of freezing of gait, the frequency of festinating gait and its relation to falls, and the frequency and severity of falls. Scores on each item range from 0 (no symptoms) to 4 (severe symptoms). The GFQ total score ranges from 0 (normal function) to 64 (severely impaired function). Negative changes from baseline indicate improvement.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=133 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Participants With Parkinson's Disease- Visit 2
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
|---|---|---|---|---|
|
Change in Gait and Falls Questionnaire (GFQ) Scores
Change from baseline to Visit 2
|
-1.70 units on a scale
Interval -3.72 to 0.33
|
—
|
—
|
—
|
|
Change in Gait and Falls Questionnaire (GFQ) Scores
Change from baseline to Visit 3
|
-0.81 units on a scale
Interval -3.03 to 1.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)Population: Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.
The Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale is a 28-item survey used to assess the frequency and severity of behaviors including gambling, sexual behavior, buying, eating, performing tasks or hobbies, repeating simple activities, and PD medication use. Scores on each item range from 0 (never) to 4 (very often). The QUIP-RS total score ranges from 0 (normal function) to 112 (severely impaired function). Negative changes from baseline indicate improvement.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=136 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Participants With Parkinson's Disease- Visit 2
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
|---|---|---|---|---|
|
Change in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Scores
Change from baseline to Visit 2
|
-1.62 units on a scale
Interval -3.21 to -0.03
|
—
|
—
|
—
|
|
Change in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Scores
Change from baseline to Visit 3
|
-2.02 units on a scale
Interval -3.76 to -0.27
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)Population: Evaluable population: participants with at least one post-baseline visit
Family caregivers were surveyed regarding the participant's need for home health care for Parkinson's Disease; the amount of time dedicated to care each week; the need of a family caregiver to reduce or change their normal work hours in order to provide care; the number of working days per month spent performing caregiver responsibilities; the number of hours of professional assistance per week needed; and the hourly costs of professional assistance incurred per week.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=137 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Participants With Parkinson's Disease- Visit 2
n=129 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
n=115 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
|---|---|---|---|---|
|
Economic and Social Impact of Family-provided Healthcare
Hours/week of care provided by family caregiver
|
51 hours
Standard Deviation 54
|
52.4 hours
Standard Deviation 54
|
53 hours
Standard Deviation 56
|
—
|
|
Economic and Social Impact of Family-provided Healthcare
Work hours/week lost by family caregiver
|
23.6 hours
Standard Deviation 23
|
21.3 hours
Standard Deviation 26.1
|
21.7 hours
Standard Deviation 22.5
|
—
|
|
Economic and Social Impact of Family-provided Healthcare
Hours/week of professional assistance
|
44.1 hours
Standard Deviation 54.7
|
32 hours
Standard Deviation 41.4
|
32 hours
Standard Deviation 42
|
—
|
SECONDARY outcome
Timeframe: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)Population: Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.
The Relative Stress Scale is a 15-item questionnaire completed by family caregivers to assess personal distress, life upset, and negative feelings regarding caring for a family member with PD. Scores on each item range from 1 (not at all) to 5 (to a high degree). The RSS total score ranges from 15 (low stress) to 75 (severe stress). Negative changes from baseline indicate improvement.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=133 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Participants With Parkinson's Disease- Visit 2
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
|---|---|---|---|---|
|
Change in Relative Stress Scale (RSS) Scores
Change from baseline to Visit 2
|
-0.20 units on a scale
Interval -1.56 to 1.17
|
—
|
—
|
—
|
|
Change in Relative Stress Scale (RSS) Scores
Change from baseline to Visit 3
|
0.09 units on a scale
Interval -1.58 to 1.76
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)Population: All enrolled participants from the screened population with all inclusion/exclusion criteria met
Concomitant diseases were coded using the MedDRA dictionary (version 15.1). Concomitant diseases present in ≥ 5% of participants started before or at Visit 1 and stopped after Visit 1 or ongoing or started after Visit 1 are presented. Non-PD medications in ≥ 5% of participants maintained with a start date previous to the date of Visit 1 and a stop date after date of Visit 1 or ongoing are listed.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=145 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Participants With Parkinson's Disease- Visit 2
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
|---|---|---|---|---|
|
Concomitant Diseases and Medications
Hypertension
|
34 Participants
|
—
|
—
|
—
|
|
Concomitant Diseases and Medications
Depression
|
22 Participants
|
—
|
—
|
—
|
|
Concomitant Diseases and Medications
Carpal tunnel syndrome
|
9 Participants
|
—
|
—
|
—
|
|
Concomitant Diseases and Medications
Diabetes mellitus
|
11 Participants
|
—
|
—
|
—
|
|
Concomitant Diseases and Medications
Hypothyroidism
|
8 Participants
|
—
|
—
|
—
|
|
Concomitant Diseases and Medications
Clozapine
|
11 Participants
|
—
|
—
|
—
|
|
Concomitant Diseases and Medications
Quetiapine fumarate
|
10 Participants
|
—
|
—
|
—
|
|
Concomitant Diseases and Medications
Clonazepam
|
10 Participants
|
—
|
—
|
—
|
|
Concomitant Diseases and Medications
Acetylsalicylic acid
|
12 Participants
|
—
|
—
|
—
|
|
Concomitant Diseases and Medications
Folic acid
|
8 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)Population: Evaluable population: participants with at least one post-baseline visit
Motor symptoms were rated by neurologists using three categories: improvement, no change, or worsening as compared to symptoms present at baseline.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=137 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Participants With Parkinson's Disease- Visit 2
n=129 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
n=115 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
|---|---|---|---|---|
|
Change in Global Effectiveness on Motor Symptoms as Compared to Baseline
Worsening
|
3 Participants
|
7 Participants
|
5 Participants
|
—
|
|
Change in Global Effectiveness on Motor Symptoms as Compared to Baseline
No change
|
2 Participants
|
13 Participants
|
22 Participants
|
—
|
|
Change in Global Effectiveness on Motor Symptoms as Compared to Baseline
Improvement
|
132 Participants
|
107 Participants
|
87 Participants
|
—
|
|
Change in Global Effectiveness on Motor Symptoms as Compared to Baseline
Missing
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)Population: Evaluable population: participants with at least one post-baseline visit
Participants were asked to rate DUODOPA therapy on a scale from 0 to 10 (0-2 worse, 3-5, unsatisfactory, 6-8 satisfactory, 9-10, very good).
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=137 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Participants With Parkinson's Disease- Visit 2
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
|---|---|---|---|---|
|
Participant Self-assessment Scale of DUODOPA Therapy
Visit 1
|
7.1 units on a scale
Standard Deviation 1.60
|
—
|
—
|
—
|
|
Participant Self-assessment Scale of DUODOPA Therapy
Visit 2
|
7.1 units on a scale
Standard Deviation 1.37
|
—
|
—
|
—
|
|
Participant Self-assessment Scale of DUODOPA Therapy
Visit 3
|
7.0 units on a scale
Standard Deviation 1.26
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Visit 1, Visit 2, (Year 1) and Visit 3 (Year 2)Population: Evaluable population: participants with at least one post-baseline visit
The total daily DUODOPA infusion dosage was documented at study visits starting at the baseline visit. One mL of DUODOPA contains 20 mg levodopa and 5 mg carbidopa monohydrate.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=133 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Participants With Parkinson's Disease- Visit 2
n=143 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
n=124 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
Partcipants With Parkinson's Disease- Visit 3
n=113 Participants
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
|---|---|---|---|---|
|
DUODOPA Total Daily Infusion Dosage
|
56.37 mL
Standard Deviation 20.14
|
56.61 mL
Standard Deviation 20.98
|
58.91 mL
Standard Deviation 17.61
|
58.8 mL
Standard Deviation 17.67
|
Adverse Events
Participants With Parkinson's Disease
Serious events: 40 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants With Parkinson's Disease
n=145 participants at risk
Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label
|
|---|---|
|
Infections and infestations
Pneumonia
|
2.8%
4/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Infections and infestations
Peritonitis
|
1.4%
2/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Infections and infestations
Administration site infection
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Infections and infestations
Stoma site infection
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.1%
3/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Injury, poisoning and procedural complications
Wrong technique in drug usage process
|
1.4%
2/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Nervous system disorders
Parkinson's disease
|
1.4%
2/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.4%
2/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Nervous system disorders
Cerebral haematoma
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Nervous system disorders
Headache
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Nervous system disorders
Hyperkinesia
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Cardiac disorders
Cardiac failure
|
2.1%
3/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
2/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
General disorders
Death
|
1.4%
2/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
General disorders
Device occlusion
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
General disorders
Medical device complication
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
General disorders
Pyrexia
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Gastrointestinal disorders
Haematemesis
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Psychiatric disorders
Agitation
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Psychiatric disorders
Hallucination, visual
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Psychiatric disorders
Suicide attempt
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
1.4%
2/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Vascular disorders
Deep vein thrombosis
|
0.69%
1/145 • Treatment emergent serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 108 weeks).
Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
Other adverse events
Adverse event data not reported
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 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