An observational study in Parkinson's Disease (PD), sponsored by AbbVie. Completed at 30 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-06.
Sponsored by AbbVie · Observational
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.
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.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's enrollment of 412 is above the median of 97 across 1,081 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →AbbVie is the lead sponsor of 967 studies on the registry; 132 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants diagnosed with advanced Parkinson's disease (APD), on current treatment with levodopa-carbidopa intestinal gel (LCIG), and treated with LCIG for at least 12 months prior to enrollment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
| Milestone | Participants With Advanced Parkinson's Disease |
|---|---|
| Started | 409 |
| Completed | 409 |
| Not completed | 0 |
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).
| percentage of participants | Participants With Advanced Parkinson's Disease |
|---|---|
| Monotherapy 1 | 29.3 |
| Monotherapy 2 | 52.3 |
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.
| percentage of participants | Participants With Advanced Parkinson's Disease |
|---|---|
| Levodopa/carbidopa | 35.0 |
| Levodopa/benserazide | 23.8 |
| Levodopa/carbidopa/entacapone | 7.3 |
| Pramipexole | 15.4 |
| Rotigotine | 13.8 |
| Ropinirole | 11.5 |
| Rasagiline | 15.4 |
| Safinamide | 0.8 |
| Selegiline | 0.8 |
| Amantadine | 16.9 |
| Other | 5.0 |
| Anticholinergics | 2.7 |
| Deep brain stimulation | 1.2 |
| Pallidotomy | 0.4 |
| Entacapone | 1.2 |
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.
| total LCIG dose per day (ml) | Participants With Advanced Parkinson's Disease |
|---|---|
| Total Daily Dose (in Milliliters) of LCIG Infusion at 12 Months After LCIG Initiation | 69.2 ± 26.0 |
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.
| participants | Participants With Advanced Parkinson's Disease |
|---|---|
| Retired | 372 |
| On sick leave | 6 |
| Unemployed | 16 |
| Working full time | 5 |
| Working part-time | 10 |
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.
| participants | Participants With Advanced Parkinson's Disease |
|---|---|
| Less help with daily activities or home care | 160 |
| More help with daily activities or home care | 83 |
| About same amount help daily activities/home care | 96 |
| Patient does not remember | 5 |
| Patient does not require any help | 65 |
The overall preference for treatment using LCIG as monotherapy compared with LCIG plus add-on PD medication, as stated by the physician.
| percentage of physicians | Percentage of Physicians |
|---|---|
| LCIG as monotherapy | 71.4 |
| LCIG plus add-on PD medication | 28.6 |
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.
| odds ratio estimate | Participants With Advanced Parkinson's Disease |
|---|---|
| Number of motor symptoms | 0.842 (0.751 to 0.944) |
| Any dopamine agonists in the past Yes | 1.564 (0.999 to 2.450) |
| Gross National Income | 0.974 (0.957 to 0.991) |
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.
| odds ratio estimate | Participants With Advanced Parkinson's Disease |
|---|---|
| Average frequency of routine visits | 2.760 (1.504 to 5.066) |
| Average number of PD and APD participants per year | 1.000 (0.999 to 1.000) |
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).
| days | Participants With Advanced Parkinson's Disease |
|---|---|
| Duration of LCIG monotherapy 1 | 932.6 ± 621.5 |
| Duration of LCIG monotherapy 2 | 945.1 ± 645.7 |
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 | Participants With Advanced Parkinson's Disease |
|---|---|
| Austria | 111.7 ± 80.6 |
| Canada | 283.2 ± 181.0 |
| Czech Republic | 298.9 ± 770.1 |
| Hungary | 387.4 ± 446.7 |
| Israel | 343.2 ± 423.7 |
| Romania | 460.8 ± 501.8 |
| Spain | 534.9 ± 750.1 |
| Sweden | 394.7 ± 463.5 |
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 | Participants With Advanced Parkinson's Disease |
|---|---|
| Time (Days) From Initial LCIG Administration to Substantial Dose Adjustment | 409.2 ± 555.5 |
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).
| days | Participants With Advanced Parkinson's Disease |
|---|---|
| Until Monotherapy 1 | 89.5 ± 220.9 |
| Until Monotherapy 2 | 70.4 ± 240.1 |
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).
| days | Participants With Advanced Parkinson's Disease |
|---|---|
| Levodopa/carbidopa | 21.3 ± 13.6 |
| Levodopa/benserazide | 34.0 ± 11.3 |
| Levodopa/carbidopa/entacapone | 21.0 ± 17.5 |
| Entacapone | 9.0 ± 7.0 |
| Pramipexole | 34.3 ± 26.5 |
| Ropinirole | 24.0 ± 2.8 |
| Rotigotine | 6.0 ± NA |
| Safinamide | 32.0 ± NA |
| Rasagiline | 57.0 ± NA |
| Amantadine | 34.3 ± 25.1 |
Collected over Up to 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With Advanced Parkinson's Disease | 0/409 (0%) | 0/409 (0%) | 0/409 (0%) |
Baseline analysis population is the full analysis set (FAS) population (409) vs. enrolled (412).
| Age, Continuous(years) | Participants With Advanced Parkinson's Disease |
|---|---|
| Mean | 69.1 ± 7.9 |
| Sex: Female, Male(Participants) | Participants With Advanced Parkinson's Disease |
|---|---|
| Female | 142 |
| Male | 267 |
| Race/Ethnicity, Customized(Participants) | Participants With Advanced Parkinson's Disease |
|---|---|
| White | 405 |
| Asian | 2 |
| Other | 2 |
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Plan to share: Undecided
Ran from Dec 2017 to primary completion in Dec 2018, 12 months.
Results were first posted in Jan 2020, 1 year after primary completion.
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