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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gailtal Klinik /ID# 202505 | Hermagor-Pressegger See | Carinthia | 9620 | Austria | ||
| Medizinische Universität Graz /ID# 202559 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36802031 | Derived | Fasano A, Garcia-Ramos R, Gurevich T, Jech R, Bergmann L, Sanchez-Solino O, Parra JC, Simu M. Levodopa-carbidopa intestinal gel in advanced Parkinson's disease: long-term results from COSMOS. J Neurol. 2023 May;270(5):2765-2775. doi: 10.1007/s00415-023-11615-3. Epub 2023 Feb 18. | |
| 36008198 | Derived | Kovacs N, Szasz J, Vela-Desojo L, Svenningsson P, Femia S, Parra JC, Sanchez-Solino O, Bergmann L, Gurevich T, Fasano A. Motor and nonmotor symptoms in patients treated with 24-hour daily levodopa-carbidopa intestinal gel infusion: Analysis of the COmedication Study assessing Mono- and cOmbination therapy with levodopa-carbidopa inteStinal gel (COSMOS). Parkinsonism Relat Disord. 2022 Dec;105:139-144. doi: 10.1016/j.parkreldis.2022.08.002. Epub 2022 Aug 17. |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 14, 2017 | Dec 16, 2019 |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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). | 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). | 12 months |
| Graz |
| Styria |
| 8010 |
| Austria |
| University of Calgary /ID# 206550 | Calgary | Alberta | T2N 4Z6 | Canada |
| Ottawa Hospital /ID# 169448 | Ottawa | Ontario | K1Y 4E9 | Canada |
| Toronto Western Hospital /ID# 169038 | Toronto | Ontario | M5T 2S8 | Canada |
| Clinique Neuro Levis /ID# 206549 | Lévis | Quebec | G6W 0M5 | Canada |
| Clinical Hosp Center Zagreb /ID# 203553 | Zagreb | 10000 | Croatia |
| Fakultni nemocnice u sv. Anny v Brne /ID# 209774 | Brno | Brno-mesto | 602 00 | Czechia |
| Fakultni Nemocnice Olomouc /ID# 209776 | Olomouc | Olomouc Region | 779 00 | Czechia |
| Vseobecna Fakultni Nemocnice /ID# 209775 | Prague | 128 08 | Czechia |
| Aiginiteio University Hospital /ID# 203476 | Athens | Attica | 11528 | Greece |
| HYGEIA Hospital /ID# 203474 | Athens | 15123 | Greece |
| Mediterraneo Hospital /ID# 203472 | Glyfada | 16675 | Greece |
| University Hospital of Ioannin /ID# 203471 | Ioannina | 45500 | Greece |
| Pecsi Tudomanyegyetem /ID# 170026 | Pécs | Pecs | 7624 | Hungary |
| Semmelweis Egyetem /ID# 170025 | Budapest | 1083 | Hungary |
| Borsod-Abauj-Zemplen Megyei /ID# 170027 | Miskolc | 3526 | Hungary |
| Szegedi Tudomanyegyetem /ID# 170028 | Szeged | 6720 | Hungary |
| Bon Secours Hospital /ID# 168424 | Cork | T12 DV56 | Ireland |
| University Hospital Galway /ID# 170754 | Galway | H91 YR71 | Ireland |
| Tel Aviv Sourasky Medical Ctr /ID# 167542 | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Sheba Medical Center /ID# 167543 | Ramat Gan | 5262100 | Israel |
| Clinic Fundeni Institute /ID# 169265 | Bucharest | Bucharest | 022328 | Romania |
| Colentina Clinical Hospital /ID# 169263 | Bucharest | 20125 | Romania |
| Emergency Clinical County Hosp /ID# 169269 | Târgu Mureş | 540042 | Romania |
| Timisoara County /ID# 169266 | Timișoara | 300736 | Romania |
| Timisoara County /ID# 169268 | Timișoara | 300736 | Romania |
| AbbVie Farmaceutica SLU /ID# 164364 | Madrid | Spain |
| Centrum for neurologi /ID# 171391 | Stockholm | 113 65 | Sweden |
| Neurologmottagningen /ID# 171390 | Stockholm | 171 76 | Sweden |
| COMPLETED |
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| NOT COMPLETED |
|
Baseline analysis population is the full analysis set (FAS) population (409) vs. enrolled (412).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Full analysis set (FAS): Participants that fulfilled all inclusion and none of the exclusion criteria. | Posted | Number | percentage of participants | 12 months |
|
|
| |||||||||||||||||||||||||||||||||
| 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. | FAS of participants starting add-on medication | Posted | Number | percentage of participants | 12 months |
|
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| 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. | FAS and only participants with non-missing data. | Posted | Mean | Standard Deviation | total LCIG dose per day (ml) | 12 months |
|
| |||||||||||||||||||||||||||||||||
| 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. | FAS | Posted | Number | participants | 12 months |
|
| ||||||||||||||||||||||||||||||||||
| 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. | FAS | Posted | Number | participants | 12 months |
|
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| 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. | Number of physicians stating LCIG as monotherapy is their overall treatment preference. | Posted | Number | percentage of physicians | 12 months |
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| 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. | FAS | Posted | Number | 95% Confidence Interval | odds ratio estimate | 12 months |
|
| |||||||||||||||||||||||||||||||||
| 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. | FAS | Posted | Number | 95% Confidence Interval | odds ratio estimate | 12 months |
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| 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). | FAS participants who reached the respective monotherapy (monotherapy 1 or monotherapy 2) | Posted | Mean | Standard Deviation | days | 12 months |
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| 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. | FAS that includes only participants with substantial dose adjustments by each country that had participants meeting these criteria | Posted | Mean | Standard Deviation | days | 12 months |
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| 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. | FAS that includes only participants with substantial dose adjustments | Posted | Mean | Standard Deviation | days | 12 months |
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| 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). | FAS | Posted | Mean | Standard Deviation | days | 12 months |
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| 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). | FAS | Posted | Mean | Standard Deviation | days | 12 months |
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Up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 409 | 0 | 409 | 0 | 409 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2019 | Dec 16, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| Other |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| LCIG as monotherapy |
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| LCIG plus add-on PD medication |
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