Parkinson's Disease (PD)
Conditions
Keywords
Advanced Parkinson's Disease, Levodopa-Carbidopa Intestinal Gel (LCIG)
Brief summary
The purpose of this study is to evaluate treatment of advanced Parkinson's Disease (PD) patients on levodopa-carbidopa intestinal gel (LCIG) monotherapy in a routine clinical setting.
Detailed description
Participants with advanced Parkinson's Disease who have been prescribed LCIG for at least 12 months will be entered into the study cohort. Clinical data will be collected by retrospective review of the participant's medical records as well as a single study visit for current data. Treatment of the participants and follow up will be according to the physician's judgment, regional regulations and the product monograph.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants diagnosed with APD and on LCIG treatment for at least 12 months * Participant must have been on continuous LCIG treatment for at least 80% of days in the preceding year * Participants must be treated by the same physician (principal investigator or co-investigator) since the initiation of LCIG treatment
Exclusion criteria
* Participation in a concurrent or a previous interventional clinical trial during which the participant was on LCIG therapy * Lack of motivation or insufficient language skills to complete the study questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants on Levodopa-Carbidopa Intestinal Gel (LCIG) Monotherapy From LCIG Initiation to 12 Months | 12 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Daily Dose (in Milliliters) of LCIG Infusion at 12 Months After LCIG Initiation | 12 months | 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. |
| Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants | 12 months | 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. |
| HCRU: Caregiver Support by Number of Participants | 12 months | 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. |
| Percentage of Physicians With Overall Preference for LCIG Monotherapy | 12 months | The overall preference for treatment using LCIG as monotherapy compared with LCIG plus add-on PD medication, as stated by the physician. |
| Predictors for Monotherapy (Participant Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation) | 12 months | 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. |
| Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation | 12 months | 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. |
| Duration (Days) of LCIG Monotherapy 1 or Monotherapy 2 | 12 months | 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). |
| Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country | 12 months | 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. |
| Time (Days) From Initial LCIG Administration to Substantial Dose Adjustment | 12 months | 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. |
| Days From Initial LCIG Administration to the Initiation of LCIG Monotherapy | 12 months | 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). |
| Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication | 12 months | 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). |
| Predictors for Monotherapy (Physician Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation) | 12 months | 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. |
Countries
Austria, Canada, Croatia, Czechia, Greece, Hungary, Ireland, Israel, Romania, Spain, Sweden
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 409 |
| Total | 409 |
Baseline characteristics
| Characteristic | Participants With Advanced Parkinson's Disease |
|---|---|
| Age, Continuous | 69.1 years STANDARD_DEVIATION 7.9 |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized White | 405 Participants |
| Sex: Female, Male Female | 142 Participants |
| Sex: Female, Male Male | 267 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 409 |
| other Total, other adverse events | 0 / 409 |
| serious Total, serious adverse events | 0 / 409 |
Outcome results
Primary
Percentage of Participants on Levodopa-Carbidopa Intestinal Gel (LCIG) Monotherapy From LCIG Initiation to 12 Months
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).
Time frame: 12 months
Population: Full analysis set (FAS): Participants that fulfilled all inclusion and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Advanced Parkinson's Disease | Percentage of Participants on Levodopa-Carbidopa Intestinal Gel (LCIG) Monotherapy From LCIG Initiation to 12 Months | Monotherapy 1 | 29.3 percentage of participants |
| Participants With Advanced Parkinson's Disease | Percentage of Participants on Levodopa-Carbidopa Intestinal Gel (LCIG) Monotherapy From LCIG Initiation to 12 Months | Monotherapy 2 | 52.3 percentage of participants |
Secondary
Days From Initial LCIG Administration to the Initiation of LCIG Monotherapy
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).
Time frame: 12 months
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Advanced Parkinson's Disease | Days From Initial LCIG Administration to the Initiation of LCIG Monotherapy | Until Monotherapy 1 | 89.5 days | Standard Deviation 220.9 |
| Participants With Advanced Parkinson's Disease | Days From Initial LCIG Administration to the Initiation of LCIG Monotherapy | Until Monotherapy 2 | 70.4 days | Standard Deviation 240.1 |
Secondary
Duration (Days) of LCIG 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).
Time frame: 12 months
Population: FAS participants who reached the respective monotherapy (monotherapy 1 or monotherapy 2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Advanced Parkinson's Disease | Duration (Days) of LCIG Monotherapy 1 or Monotherapy 2 | Duration of LCIG monotherapy 1 | 932.6 days | Standard Deviation 621.5 |
| Participants With Advanced Parkinson's Disease | Duration (Days) of LCIG Monotherapy 1 or Monotherapy 2 | Duration of LCIG monotherapy 2 | 945.1 days | Standard Deviation 645.7 |
Secondary
HCRU: Caregiver Support by Number of Participants
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.
Time frame: 12 months
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Advanced Parkinson's Disease | HCRU: Caregiver Support by Number of Participants | Less help with daily activities or home care | 160 participants |
| Participants With Advanced Parkinson's Disease | HCRU: Caregiver Support by Number of Participants | More help with daily activities or home care | 83 participants |
| Participants With Advanced Parkinson's Disease | HCRU: Caregiver Support by Number of Participants | About same amount help daily activities/home care | 96 participants |
| Participants With Advanced Parkinson's Disease | HCRU: Caregiver Support by Number of Participants | Patient does not remember | 5 participants |
| Participants With Advanced Parkinson's Disease | HCRU: Caregiver Support by Number of Participants | Patient does not require any help | 65 participants |
Secondary
Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants
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.
Time frame: 12 months
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Advanced Parkinson's Disease | Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants | Retired | 372 participants |
| Participants With Advanced Parkinson's Disease | Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants | On sick leave | 6 participants |
| Participants With Advanced Parkinson's Disease | Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants | Unemployed | 16 participants |
| Participants With Advanced Parkinson's Disease | Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants | Working full time | 5 participants |
| Participants With Advanced Parkinson's Disease | Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants | Working part-time | 10 participants |
Secondary
Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
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.
Time frame: 12 months
Population: FAS of participants starting add-on medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Advanced Parkinson's Disease | Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation | Levodopa/carbidopa | 35.0 percentage of participants |
| Participants With Advanced Parkinson's Disease | Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation | Levodopa/benserazide | 23.8 percentage of participants |
| Participants With Advanced Parkinson's Disease | Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation | Levodopa/carbidopa/entacapone | 7.3 percentage of participants |
| Participants With Advanced Parkinson's Disease | Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation | Pramipexole | 15.4 percentage of participants |
| Participants With Advanced Parkinson's Disease | Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation | Rotigotine | 13.8 percentage of participants |
| Participants With Advanced Parkinson's Disease | Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation | Ropinirole | 11.5 percentage of participants |
| Participants With Advanced Parkinson's Disease | Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation | Rasagiline | 15.4 percentage of participants |
| Participants With Advanced Parkinson's Disease | Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation | Safinamide | 0.8 percentage of participants |
| Participants With Advanced Parkinson's Disease | Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation | Selegiline | 0.8 percentage of participants |
| Participants With Advanced Parkinson's Disease | Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation | Amantadine | 16.9 percentage of participants |
| Participants With Advanced Parkinson's Disease | Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation | Other | 5.0 percentage of participants |
| Participants With Advanced Parkinson's Disease | Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation | Anticholinergics | 2.7 percentage of participants |
| Participants With Advanced Parkinson's Disease | Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation | Deep brain stimulation | 1.2 percentage of participants |
| Participants With Advanced Parkinson's Disease | Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation | Pallidotomy | 0.4 percentage of participants |
| Participants With Advanced Parkinson's Disease | Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation | Entacapone | 1.2 percentage of participants |
Secondary
Percentage of Physicians With Overall Preference for LCIG Monotherapy
The overall preference for treatment using LCIG as monotherapy compared with LCIG plus add-on PD medication, as stated by the physician.
Time frame: 12 months
Population: Number of physicians stating LCIG as monotherapy is their overall treatment preference.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Advanced Parkinson's Disease | Percentage of Physicians With Overall Preference for LCIG Monotherapy | LCIG as monotherapy | 71.4 percentage of physicians |
| Participants With Advanced Parkinson's Disease | Percentage of Physicians With Overall Preference for LCIG Monotherapy | LCIG plus add-on PD medication | 28.6 percentage of physicians |
Secondary
Predictors for Monotherapy (Participant Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation)
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.
Time frame: 12 months
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Advanced Parkinson's Disease | Predictors for Monotherapy (Participant Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation) | Number of motor symptoms | 0.842 odds ratio estimate |
| Participants With Advanced Parkinson's Disease | 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 |
| Participants With Advanced Parkinson's Disease | Predictors for Monotherapy (Participant Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation) | Gross National Income | 0.974 odds ratio estimate |
Secondary
Predictors for Monotherapy (Physician Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation)
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.
Time frame: 12 months
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Advanced Parkinson's Disease | 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 |
| Participants With Advanced Parkinson's Disease | 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 |
Secondary
Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication
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).
Time frame: 12 months
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Advanced Parkinson's Disease | Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication | Levodopa/carbidopa | 21.3 days | Standard Deviation 13.6 |
| Participants With Advanced Parkinson's Disease | Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication | Levodopa/benserazide | 34.0 days | Standard Deviation 11.3 |
| Participants With Advanced Parkinson's Disease | Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication | Levodopa/carbidopa/entacapone | 21.0 days | Standard Deviation 17.5 |
| Participants With Advanced Parkinson's Disease | Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication | Entacapone | 9.0 days | Standard Deviation 7 |
| Participants With Advanced Parkinson's Disease | Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication | Pramipexole | 34.3 days | Standard Deviation 26.5 |
| Participants With Advanced Parkinson's Disease | Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication | Ropinirole | 24.0 days | Standard Deviation 2.8 |
| Participants With Advanced Parkinson's Disease | Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication | Rotigotine | 6.0 days | — |
| Participants With Advanced Parkinson's Disease | Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication | Safinamide | 32.0 days | — |
| Participants With Advanced Parkinson's Disease | Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication | Rasagiline | 57.0 days | — |
| Participants With Advanced Parkinson's Disease | Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication | Amantadine | 34.3 days | Standard Deviation 25.1 |
Secondary
Time (Days) From Initial LCIG Administration to Substantial Dose Adjustment
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.
Time frame: 12 months
Population: FAS that includes only participants with substantial dose adjustments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Advanced Parkinson's Disease | Time (Days) From Initial LCIG Administration to Substantial Dose Adjustment | 409.2 days | Standard Deviation 555.5 |
Secondary
Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country
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.
Time frame: 12 months
Population: FAS that includes only participants with substantial dose adjustments by each country that had participants meeting these criteria
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Advanced Parkinson's Disease | Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country | Austria | 111.7 days | Standard Deviation 80.6 |
| Participants With Advanced Parkinson's Disease | Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country | Canada | 283.2 days | Standard Deviation 181 |
| Participants With Advanced Parkinson's Disease | Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country | Czech Republic | 298.9 days | Standard Deviation 770.1 |
| Participants With Advanced Parkinson's Disease | Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country | Hungary | 387.4 days | Standard Deviation 446.7 |
| Participants With Advanced Parkinson's Disease | Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country | Israel | 343.2 days | Standard Deviation 423.7 |
| Participants With Advanced Parkinson's Disease | Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country | Romania | 460.8 days | Standard Deviation 501.8 |
| Participants With Advanced Parkinson's Disease | Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country | Spain | 534.9 days | Standard Deviation 750.1 |
| Participants With Advanced Parkinson's Disease | Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country | Sweden | 394.7 days | Standard Deviation 463.5 |
Secondary
Total Daily Dose (in Milliliters) of LCIG Infusion at 12 Months After LCIG Initiation
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.
Time frame: 12 months
Population: FAS and only participants with non-missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Advanced Parkinson's Disease | Total Daily Dose (in Milliliters) of LCIG Infusion at 12 Months After LCIG Initiation | 69.2 total LCIG dose per day (ml) | Standard Deviation 26 |