Trial Outcomes & Findings for COmedication Study Assessing Mono- and cOmbination Therapy With Levodopa-carbidopa inteStinal Gel (NCT NCT03362879)
NCT ID: NCT03362879
Last Updated: 2020-01-06
Results Overview
The percentage of participants on LCIG monotherapy from immediately following LCIG initiation to 12 months. LCIG monotherapy means that the participant is not on any add-on Parkinson's (PD) medication/PD therapy at the respective time point (monotherapy 1) or that the participant is allowed to take an add-on PD medication/PD therapy at the respective time point but only in the evening after the LCIG infusion is completed (monotherapy 2).
COMPLETED
412 participants
12 months
2020-01-06
Participant Flow
In total, 412 participants were enrolled in the study and 409 of these participants fulfilled all inclusion and none of the exclusion criteria and, thus, were included in the full analysis set.
Participant milestones
| Measure |
Participants With Advanced Parkinson's Disease
Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
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|---|---|
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Overall Study
STARTED
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409
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Overall Study
COMPLETED
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409
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COmedication Study Assessing Mono- and cOmbination Therapy With Levodopa-carbidopa inteStinal Gel
Baseline characteristics by cohort
| Measure |
Participants With Advanced Parkinson's Disease
n=409 Participants
Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
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|---|---|
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Age, Continuous
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69.1 years
STANDARD_DEVIATION 7.9 • n=93 Participants
|
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Sex: Female, Male
Female
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142 Participants
n=93 Participants
|
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Sex: Female, Male
Male
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267 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
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405 Participants
n=93 Participants
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Race/Ethnicity, Customized
Asian
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2 Participants
n=93 Participants
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Race/Ethnicity, Customized
Other
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2 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Full analysis set (FAS): Participants that fulfilled all inclusion and none of the exclusion criteria.
The percentage of participants on LCIG monotherapy from immediately following LCIG initiation to 12 months. LCIG monotherapy means that the participant is not on any add-on Parkinson's (PD) medication/PD therapy at the respective time point (monotherapy 1) or that the participant is allowed to take an add-on PD medication/PD therapy at the respective time point but only in the evening after the LCIG infusion is completed (monotherapy 2).
Outcome measures
| Measure |
Participants With Advanced Parkinson's Disease
n=409 Participants
Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
|
|---|---|
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Percentage of Participants on Levodopa-Carbidopa Intestinal Gel (LCIG) Monotherapy From LCIG Initiation to 12 Months
Monotherapy 1
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29.3 percentage of participants
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Percentage of Participants on Levodopa-Carbidopa Intestinal Gel (LCIG) Monotherapy From LCIG Initiation to 12 Months
Monotherapy 2
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52.3 percentage of participants
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SECONDARY outcome
Timeframe: 12 monthsPopulation: FAS of participants starting add-on medication
LCIG monotherapy means that the participant is not on any add-on PD medication/PD therapy at the respective time point (monotherapy 1) or that the participant is allowed to take an add-on PD medication/PD therapy at the respective time point but only in the evening after the LCIG infusion is completed (monotherapy 2). PD medications were captured by time point and category from the initiation of LCIG therapy until the introduction of each add-on PD medication taken. Categories included levodopa, catechol-O-methyltransferase (COMT) inhibitors,dopamine agonist (excluding apomorphine), monoamine oxidase (MAO) inhibitor, n-methyl-d-aspartate receptor (NMDA) antagonist, apomorphine, anticholinergics, surgical therapy, or other. Participants may have initiated more than one PD medication or category.
Outcome measures
| Measure |
Participants With Advanced Parkinson's Disease
n=260 Participants
Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
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|---|---|
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Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
Levodopa/carbidopa
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35.0 percentage of participants
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Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
Levodopa/benserazide
|
23.8 percentage of participants
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Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
Levodopa/carbidopa/entacapone
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7.3 percentage of participants
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Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
Pramipexole
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15.4 percentage of participants
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Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
Rotigotine
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13.8 percentage of participants
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Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
Ropinirole
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11.5 percentage of participants
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Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
Rasagiline
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15.4 percentage of participants
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Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
Safinamide
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0.8 percentage of participants
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Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
Selegiline
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0.8 percentage of participants
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Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
Amantadine
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16.9 percentage of participants
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Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
Other
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5.0 percentage of participants
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Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
Anticholinergics
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2.7 percentage of participants
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Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
Deep brain stimulation
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1.2 percentage of participants
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|
Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
Pallidotomy
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0.4 percentage of participants
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Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
Entacapone
|
1.2 percentage of participants
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SECONDARY outcome
Timeframe: 12 monthsPopulation: FAS and only participants with non-missing data.
Physicians were asked to document the LCIG infusion details at 12 months after LCIG initiation, including the total daily dose. Total dose per day was calculated as morning dose + continuous dose x duration of infusion + extra dose. Abbreviations: ml = milliliters.
Outcome measures
| Measure |
Participants With Advanced Parkinson's Disease
n=377 Participants
Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
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|---|---|
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Total Daily Dose (in Milliliters) of LCIG Infusion at 12 Months After LCIG Initiation
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69.2 total LCIG dose per day (ml)
Standard Deviation 26.0
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SECONDARY outcome
Timeframe: 12 monthsPopulation: FAS
The HCRU questionnaire is used to assess healthcare resource utilization. Participants were asked about their occupational status (primary occupation), caregiver support (change in amount of caregiver help needed with daily activities/home care), and participant´s opinion on Parkinson's disease medication (number of pills in addition to LCIG the participant was willing to take each day). Physicians were asked to report details regarding participant visits and hospital admissions in the 12 months prior to the study visit.
Outcome measures
| Measure |
Participants With Advanced Parkinson's Disease
n=409 Participants
Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
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|---|---|
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Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants
Retired
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372 participants
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Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants
On sick leave
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6 participants
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Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants
Unemployed
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16 participants
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Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants
Working full time
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5 participants
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Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants
Working part-time
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10 participants
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SECONDARY outcome
Timeframe: 12 monthsPopulation: FAS
The HCRU questionnaire is used to assess healthcare resource utilization. Participants were asked about their occupational status (primary occupation), caregiver support (change in amount of caregiver help needed with daily activities/home care), and participant´s opinion on Parkinson's disease medication (number of pills in addition to LCIG the participant was willing to take each day). Physicians were asked to report details regarding participant visits and hospital admissions in the 12 months prior to the study visit.
Outcome measures
| Measure |
Participants With Advanced Parkinson's Disease
n=409 Participants
Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
|
|---|---|
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HCRU: Caregiver Support by Number of Participants
Less help with daily activities or home care
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160 participants
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HCRU: Caregiver Support by Number of Participants
More help with daily activities or home care
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83 participants
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HCRU: Caregiver Support by Number of Participants
About same amount help daily activities/home care
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96 participants
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HCRU: Caregiver Support by Number of Participants
Patient does not remember
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5 participants
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HCRU: Caregiver Support by Number of Participants
Patient does not require any help
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65 participants
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SECONDARY outcome
Timeframe: 12 monthsPopulation: Number of physicians stating LCIG as monotherapy is their overall treatment preference.
The overall preference for treatment using LCIG as monotherapy compared with LCIG plus add-on PD medication, as stated by the physician.
Outcome measures
| Measure |
Participants With Advanced Parkinson's Disease
n=56 Participants
Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
|
|---|---|
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Percentage of Physicians With Overall Preference for LCIG Monotherapy
LCIG as monotherapy
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71.4 percentage of physicians
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Percentage of Physicians With Overall Preference for LCIG Monotherapy
LCIG plus add-on PD medication
|
28.6 percentage of physicians
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SECONDARY outcome
Timeframe: 12 monthsPopulation: FAS
LCIG monotherapy 1 means that the participant is not on any add-on Parkinson's (PD) medication/PD therapy at the respective time point. The influence of predefined variables was evaluated using multivariable logistic regression models. The target variables were analyzed using two different sets of potential predictors: one set containing participant data and one set containing site and physician data.
Outcome measures
| Measure |
Participants With Advanced Parkinson's Disease
n=409 Participants
Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
|
|---|---|
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Predictors for Monotherapy (Participant Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation)
Number of motor symptoms
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0.842 odds ratio estimate
Interval 0.751 to 0.944
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Predictors for Monotherapy (Participant Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation)
Any dopamine agonists in the past Yes
|
1.564 odds ratio estimate
Interval 0.999 to 2.45
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Predictors for Monotherapy (Participant Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation)
Gross National Income
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0.974 odds ratio estimate
Interval 0.957 to 0.991
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SECONDARY outcome
Timeframe: 12 monthsPopulation: FAS
LCIG monotherapy 1 means that the participant is not on any add-on Parkinson's (PD) medication/PD therapy at the respective time point. The influence of predefined variables was evaluated using multivariable logistic regression models. The target variables were analyzed using two different sets of potential predictors: one set containing participant data and one set containing site and physician data. Physician data in table shown as "average frequency of routine visits" includes average frequency of routine visits for advanced Parkinson's disease (APD) participants on device aided therapy ≥3x/years.
Outcome measures
| Measure |
Participants With Advanced Parkinson's Disease
n=409 Participants
Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
|
|---|---|
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Predictors for Monotherapy (Physician Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation)
Average frequency of routine visits
|
2.760 odds ratio estimate
Interval 1.504 to 5.066
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Predictors for Monotherapy (Physician Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation)
Average number of PD and APD participants per year
|
1.000 odds ratio estimate
Interval 0.999 to 1.0
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SECONDARY outcome
Timeframe: 12 monthsPopulation: FAS participants who reached the respective monotherapy (monotherapy 1 or monotherapy 2)
LCIG monotherapy means that the participant is not on any add-on PD medication/PD therapy at the respective time point (monotherapy 1) or that the participant is allowed to take an add-on PD medication/PD therapy at the respective time point but only in the evening after the LCIG infusion is completed (monotherapy 2). Duration of LCIG monotherapy was calculated for all participants who reached the respective monotherapy as time from LCIG initiation until LCIG is given as a monotherapy (separately for monotherapy 1 and monotherapy 2 definition).
Outcome measures
| Measure |
Participants With Advanced Parkinson's Disease
n=409 Participants
Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
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|---|---|
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Duration (Days) of LCIG Monotherapy 1 or Monotherapy 2
Duration of LCIG monotherapy 1
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932.6 days
Standard Deviation 621.5
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Duration (Days) of LCIG Monotherapy 1 or Monotherapy 2
Duration of LCIG monotherapy 2
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945.1 days
Standard Deviation 645.7
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SECONDARY outcome
Timeframe: 12 monthsPopulation: FAS that includes only participants with substantial dose adjustments by each country that had participants meeting these criteria
Time for substantial change was determined as the time from LCIG initiation until the first substantial dose change in days 12 months after LCIG initiation. A substantial change was defined as a change of at least 20% compared to the LCIG dose at LCIG initiation.
Outcome measures
| Measure |
Participants With Advanced Parkinson's Disease
n=409 Participants
Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
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|---|---|
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Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country
Austria
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111.7 days
Standard Deviation 80.6
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Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country
Canada
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283.2 days
Standard Deviation 181.0
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Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country
Czech Republic
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298.9 days
Standard Deviation 770.1
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Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country
Hungary
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387.4 days
Standard Deviation 446.7
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Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country
Israel
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343.2 days
Standard Deviation 423.7
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Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country
Romania
|
460.8 days
Standard Deviation 501.8
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Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country
Spain
|
534.9 days
Standard Deviation 750.1
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Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country
Sweden
|
394.7 days
Standard Deviation 463.5
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SECONDARY outcome
Timeframe: 12 monthsPopulation: FAS that includes only participants with substantial dose adjustments
Time for substantial change was determined as the time from LCIG initiation until the first substantial dose change in days 12 months after LCIG initiation. A substantial change was defined as a change of at least 20% compared to the LCIG dose at LCIG initiation.
Outcome measures
| Measure |
Participants With Advanced Parkinson's Disease
n=122 Participants
Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
|
|---|---|
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Time (Days) From Initial LCIG Administration to Substantial Dose Adjustment
|
409.2 days
Standard Deviation 555.5
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SECONDARY outcome
Timeframe: 12 monthsPopulation: FAS
Time (in days) from LCIG initiation until monotherapy was calculated for those participants who were not on monotherapy (i.e., needed additional PD medication during LCIG infusion) at LCIG initiation, but reached monotherapy during the study. LCIG monotherapy means that the participant is not on any add-on PD medication/PD therapy at the respective time point (monotherapy 1) or that the participant is allowed to take an add-on PD medication/PD therapy at the respective time point but only in the evening after the LCIG infusion is completed (monotherapy 2).
Outcome measures
| Measure |
Participants With Advanced Parkinson's Disease
n=409 Participants
Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
|
|---|---|
|
Days From Initial LCIG Administration to the Initiation of LCIG Monotherapy
Until Monotherapy 1
|
89.5 days
Standard Deviation 220.9
|
|
Days From Initial LCIG Administration to the Initiation of LCIG Monotherapy
Until Monotherapy 2
|
70.4 days
Standard Deviation 240.1
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SECONDARY outcome
Timeframe: 12 monthsPopulation: FAS
LCIG monotherapy means that the participant is not on any add-on PD medication/PD therapy at the respective time point (monotherapy 1). The number of days for tapering process is the number of days between maximum and minimum daily dose; participants with minimum (or maximum, respectively) daily dose not at the end of the tapering process were checked. A maximum duration of approximately 2 months of the tapering process was allowed (otherwise the tapering process was set to missing).
Outcome measures
| Measure |
Participants With Advanced Parkinson's Disease
n=409 Participants
Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
|
|---|---|
|
Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication
Levodopa/carbidopa
|
21.3 days
Standard Deviation 13.6
|
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Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication
Levodopa/benserazide
|
34.0 days
Standard Deviation 11.3
|
|
Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication
Levodopa/carbidopa/entacapone
|
21.0 days
Standard Deviation 17.5
|
|
Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication
Entacapone
|
9.0 days
Standard Deviation 7.0
|
|
Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication
Pramipexole
|
34.3 days
Standard Deviation 26.5
|
|
Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication
Ropinirole
|
24.0 days
Standard Deviation 2.8
|
|
Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication
Rotigotine
|
6.0 days
Standard Deviation NA
Standard deviation not calculated due to insufficient number of participants analyzed.
|
|
Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication
Safinamide
|
32.0 days
Standard Deviation NA
Standard deviation not calculated due to insufficient number of participants analyzed.
|
|
Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication
Rasagiline
|
57.0 days
Standard Deviation NA
Standard deviation not calculated due to insufficient number of participants analyzed.
|
|
Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication
Amantadine
|
34.3 days
Standard Deviation 25.1
|
Adverse Events
Participants With Advanced Parkinson's Disease
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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