Trial Outcomes & Findings for Patient- and Caregiver-reported Symptoms and Outcomes With Levodopa/Carbidopa Intestinal Gel for the Treatment of Advanced Parkinson's Disease (NCT NCT02289729)

NCT ID: NCT02289729

Last Updated: 2019-01-30

Results Overview

The PDQ-39 contains 39 items: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (score 0 to 4 on a Likert scale). The global score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

• Recruitment status: COMPLETED
• Target enrollment: 62 participants
• Primary outcome timeframe: Baseline, Month 6 (±15 days)
• Results posted on: 2019-01-30

Participant Flow

A total of 62 participants were enrolled; 59 were evaluable and 3 were non-evaluable because they did not participate in the nasoduodenal test phase and they did not receive any dose of levodopa/carbidopa intestinal infusion gel (LCIG).

Participant milestones

Measure	All Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Overall Study STARTED	59
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	All Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Overall Study Lack of Efficacy	3
Overall Study Very Narrow Therapeutic Margin	1
Overall Study Withdrawal by Subject	1
Overall Study Death	1

Baseline Characteristics

Patient- and Caregiver-reported Symptoms and Outcomes With Levodopa/Carbidopa Intestinal Gel for the Treatment of Advanced Parkinson's Disease

Baseline characteristics by cohort

Measure	All Participants n=59 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Age, Continuous	67.93 years STANDARD_DEVIATION 7.53 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The PDQ-39 contains 39 items: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (score 0 to 4 on a Likert scale). The global score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in Parkinson's Disease Questionnaire-39 Item (PDQ-39) Global Score at Month 6	-12.81 units on a scale Standard Deviation 14.65

PRIMARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The mobility domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in PDQ-39 Mobility Domain Score at Month 6	-16.92 units on a scale Standard Deviation 24.90

PRIMARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The activities of daily living domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in PDQ-39 Activities of Daily Living Domain Score at Month 6	-18.43 units on a scale Standard Deviation 23.52

PRIMARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The emotional well-being domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in PDQ-39 Emotional Well-Being Domain Score at Month 6	-13.06 units on a scale Standard Deviation 19.56

PRIMARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The stigma domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in PDQ-39 Stigma Domain Score at Month 6	-6.85 units on a scale Standard Deviation 20.53

PRIMARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The social support domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in PDQ-39 Social Support Domain Score at Month 6	-2.08 units on a scale Standard Deviation 15.56

PRIMARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The cognition domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in PDQ-39 Cognition Domain Score at Month 6	-13.22 units on a scale Standard Deviation 19.94

PRIMARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The communication domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in PDQ-39 Communication Domain Score at Month 6	-9.13 units on a scale Standard Deviation 17.17

PRIMARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The bodily discomfort domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in PDQ-39 Bodily Discomfort Domain Score at Month 6	-9.13 units on a scale Standard Deviation 24.93

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS-III was used in ON state. The motor examination contains 27 items. Each item is scored in a Likert scale from 0 to 4. The UPDRS-III score was calculated summing the score of each item, ranging from 0 to 108, with higher score indicating more impairment.

Outcome measures

Measure	All Participants n=53 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in Unified Parkinson's Disease Rating Scale Part III (UPDRS-III): Motor Examination at Month 6	-6.51 units on a scale Standard Deviation 11.83

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The global score was calculated summing the score of each item (severity x frequency), ranging from 0 to 360, with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Non-Motor Symptom Scale (NMSS) Global Score at Month 6	-35.75 units on a scale Standard Deviation 31.12

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The cardiovascular domain score ranges from 0 to 24 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in NMSS Cardiovascular Domain Score at Month 6	-1.81 units on a scale Standard Deviation 3.51

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The sleep/fatigue domain score ranges from 0 to 48 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in NMSS Sleep/Fatigue Domain Score at Month 6	-8.73 units on a scale Standard Deviation 7.77

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The mood/cognition domain score ranges from 0 to 72 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in NMSS Mood/Cognition Domain Score at Month 6	-5.83 units on a scale Standard Deviation 13.84

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The perceptual problems/hallucinations domain score ranges from 0 to 36 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in NMSS Perceptual Problems/Hallucinations Domain Score at Month 6	2.12 units on a scale Standard Deviation 5.03

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The attention/memory domain score ranges from 0 to 36 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in NMSS Attention/Memory Domain Score at Month 6	-1.12 units on a scale Standard Deviation 6.21

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The gastrointestinal tract domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in NMSS Gastrointestinal Tract Domain Score at Month 6	-3.58 units on a scale Standard Deviation 5.08

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The urinary domain score ranges from 0 to 36 with a lower score indicating fewer symptoms.A negative change from baseline indicates improvement in symptoms.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in NMSS Urinary Domain Score at Month 6	-5.19 units on a scale Standard Deviation 10.24

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The sexual function domain score ranges from 0 to 24 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in NMSS Sexual Function Domain Score at Month 6	-2.94 units on a scale Standard Deviation 6.80

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The miscellaneous domain score ranges from 0 to 48 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.

Outcome measures

Measure	All Participants n=51 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in NMSS Miscellaneous Domain Score at Month 6	-4.47 units on a scale Standard Deviation 8.00

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The Norris/Bond-Lader VAS measures emotional well-being status with a 16-item visual analogue mood rating scale. The VAS consisted of 16 visual analogue items each representing opposite extremes of mood, with the following labels at each end: alert/drowsy, calm/excited, strong/weak, muzzy/clear-headed, well-coordinated/clumsy, lethargic/energetic, contented/dreamy, incompetent/proficient, happy/sad, antagonistic/amicable, interested/bored, withdrawn/gregarious. These scales loaded on 3 domains (alert, strong, clear-headed, well-coordinated, energetic, quick-witted, attentive, proficient, interested); (contented, tranquil, happy, amicable, gregarious); (calm, relaxed). For each individual scale, a line was drawn between each mood state and its opposite and participants rated their current mood by placing a vertical mark on the line. Scores (global, and for each domain) ranged from 0 to 100, with lower scores indicating more positive mood.

Outcome measures

Measure	All Participants n=51 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Mean Global Score at Month 6	-6.63 units on a scale Standard Deviation 21.15

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The Norris/Bond-Lader VAS measures emotional well-being status with a 16-item visual analogue mood rating scale. The VAS consisted of 16 visual analogue items each representing opposite extremes of mood, with the following labels at each end: alert/drowsy, calm/excited, strong/weak, muzzy/clear-headed, well-coordinated/clumsy, lethargic/energetic, contented/dreamy, incompetent/proficient, happy/sad, antagonistic/amicable, interested/bored, withdrawn/gregarious. These scales loaded on 3 domains (alert, strong, clear-headed, well-coordinated, energetic, quick-witted, attentive, proficient, interested); (contented, tranquil, happy, amicable, gregarious); (calm, relaxed). For each individual scale, a line was drawn between each mood state and its opposite and participants rated their current mood by placing a vertical mark on the line. Scores (global, and for each domain) ranged from 0 to 100, with lower scores indicating more positive mood.

Outcome measures

Measure	All Participants n=51 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Alertness/Sedation Sub-Scale Score at Month 6	-7.38 units on a scale Standard Deviation 23.27

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The Norris/Bond-Lader VAS measures emotional well-being status with a 16-item visual analogue mood rating scale. The VAS consisted of 16 visual analogue items each representing opposite extremes of mood, with the following labels at each end: alert/drowsy, calm/excited, strong/weak, muzzy/clear-headed, well-coordinated/clumsy, lethargic/energetic, contented/dreamy, incompetent/proficient, happy/sad, antagonistic/amicable, interested/bored, withdrawn/gregarious. These scales loaded on 3 domains (alert, strong, clear-headed, well-coordinated, energetic, quick-witted, attentive, proficient, interested); (contented, tranquil, happy, amicable, gregarious); (calm, relaxed). For each individual scale, a line was drawn between each mood state and its opposite and participants rated their current mood by placing a vertical mark on the line. Scores (global, and for each domain) ranged from 0 to 100, with lower scores indicating more positive mood.

Outcome measures

Measure	All Participants n=51 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Contented/Discontented Sub-Scale Score at Month 6	-3.37 units on a scale Standard Deviation 21.92

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The Norris/Bond-Lader VAS measures emotional well-being status with a 16-item visual analogue mood rating scale. The VAS consisted of 16 visual analogue items each representing opposite extremes of mood, with the following labels at each end: alert/drowsy, calm/excited, strong/weak, muzzy/clear-headed, well-coordinated/clumsy, lethargic/energetic, contented/dreamy, incompetent/proficient, happy/sad, antagonistic/amicable, interested/bored, withdrawn/gregarious. These scales loaded on 3 domains (alert, strong, clear-headed, well-coordinated, energetic, quick-witted, attentive, proficient, interested); (contented, tranquil, happy, amicable, gregarious); (calm, relaxed). For each individual scale, a line was drawn between each mood state and its opposite and participants rated their current mood by placing a vertical mark on the line. Scores (global, and for each domain) ranged from 0 to 100, with lower scores indicating more positive mood.

Outcome measures

Measure	All Participants n=51 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Calmness/Relaxation Sub-Scale Score at Month 6	-11.58 units on a scale Standard Deviation 27.94

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The PFS-16 comprises 16 items with five polytomous response categories (strongly disagree, disagree, do not agree or disagree, agree, and strongly agree). Responses were scored from 0 (strongly disagree) to 4 (strongly agree), yielding a summed total score ranging from 0 (no fatigue) to 64 (most severe fatigue). The cut-point of ≥ 3.30 was used to identified those perceiving fatigue to be a problem.

Outcome measures

Measure	All Participants n=51 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in Parkinson Fatigue Scale (PFS-16) at Month 6	-0.56 units on a scale Standard Deviation 1.01

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The AS is an inventory of 14 questions that assess cognitive and behavioral symptoms of emotional apathy. Each is rated from 0 to 3 on a Likert scale. The total scores for AS ranges from 0 (no apathy) to 42 (most apathetic). AS scores ≥ 14 were considered apathetic.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Score of the Apathy Scale (AS) to Month 6	-0.52 units on a scale Standard Deviation 6.86

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The BDI-II is a 21-item self-report multiple-choice inventory. Items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Raw scores from 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression, and 29-63 indicates severe depression.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in Beck Depression Inventory, Second Edition (BDI-II) at Month 6	-5.15 units on a scale Standard Deviation 9.39

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The BAI is a 21-item self-report multiple-choice inventory. Items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Raw scores from 0-7 indicates minimal anxiety, 8-15 indicates mild anxiety, 16-25 indicates moderate anxiety, and 25-63 indicates severe anxiety.

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in Beck Anxiety Inventory (BAI) at Month 6	-6.21 units on a scale Standard Deviation 9.57

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 5-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total composite score ranging between 0 and 68, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Composite Score at Month 6	16.15 units on a scale Standard Deviation 16.80

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total undesirable side effects score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).

Outcome measures

Measure	All Participants n=46 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Undesirable Side Effects at Month 6	-25.00 units on a scale Standard Deviation 39.05

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total treatment effectiveness score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).

Outcome measures

Measure	All Participants n=51 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Treatment Effectiveness at Month 6	30.39 units on a scale Standard Deviation 31.57

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total convenience of use score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).

Outcome measures

Measure	All Participants n=51 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Convenience of Use at Month 6	19.77 units on a scale Standard Deviation 33.83

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total impact on daily living activities score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Impact on Daily Living Activities at Month 6	18.75 units on a scale Standard Deviation 30.78

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total medical care score ranging between 0 and 8, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).

Outcome measures

Measure	All Participants n=52 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Medical Care at Month 6	4.09 units on a scale Standard Deviation 22.51

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total global satisfaction score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).

Outcome measures

Measure	All Participants n=51 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Global Satisfaction at Month 6	44.44 units on a scale Standard Deviation 32.00

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The SQLC is designed to both qualitatively and quantitatively evaluate the impact of a patient's disease on the caregiver's quality of life. The SQLC questionnaire consists of 16 questions that evaluate 3 domains: professional activities (questions 1-4), social and leisure activities (questions 5-9), and caregiving responsibilities (questions 10-16). Composite scores range from 0 to 149, with higher scores indicating higher quality of life.

Outcome measures

Measure	All Participants n=47 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Composite Score at Month 6	3.21 units on a scale Standard Deviation 21.57

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The SQLC is designed to both qualitatively and quantitatively evaluate the impact of a patient's disease on the caregiver's quality of life. The SQLC questionnaire consists of 16 questions that evaluate 3 domains: professional activities (questions 1-4), social and leisure activities (questions 5-9), and caregiving responsibilities (questions 10-16). Professional activities scores range from 0 to 38, with higher scores indicating higher quality of life.

Outcome measures

Measure	All Participants n=47 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Professional Activities at Month 6	2.55 units on a scale Standard Deviation 12.06

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The SQLC is designed to both qualitatively and quantitatively evaluate the impact of a patient's disease on the caregiver's quality of life. The SQLC questionnaire consists of 16 questions that evaluate 3 domains: professional activities (questions 1-4), social and leisure activities (questions 5-9), and caregiving responsibilities (questions 10-16). Social and leisure activities scores range from 0 to 58, with higher scores indicating higher quality of life.

Outcome measures

Measure	All Participants n=47 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Social and Leisure Activities at Month 6	-0.21 units on a scale Standard Deviation 6.18

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The SQLC is designed to both qualitatively and quantitatively evaluate the impact of a patient's disease on the caregiver's quality of life. The SQLC questionnaire consists of 16 questions that evaluate 3 domains: professional activities (questions 1-4), social and leisure activities (questions 5-9), and caregiving responsibilities (questions 10-16). Caregiving responsibilities scores range from 0 to 53, with higher scores indicating higher quality of life.

Outcome measures

Measure	All Participants n=47 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Caregiving Responsibilities at Month 6	0.87 units on a scale Standard Deviation 7.11

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The ZBI is a 22-item questionnaire in which caregivers must evaluate the level of agreement on a 5-point Likert scale from 0 to 4. The total score is obtained by the sum of the scores of the items. This total score represents a level of caregiver burden, with a range of 0 indicating no burden to 88 indicating completely overloaded.

Outcome measures

Measure	All Participants n=47 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in Zarit Burden Interview (ZBI) at Month 6	-0.32 units on a scale Standard Deviation 10.26

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The CSI is a 13-item questionnaire based on identified common stressors. Answers are in yes/no format. Scoring is 1 point for each "yes" and 0 for each "no". The total score is obtained by the sum of the scores of the items. Minimum score is 0 (no stress) and maximum score is 13 (most stress). A score ≥ 7 indicates a high level of stress.

Outcome measures

Measure	All Participants n=47 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in the Caregiver Stress Index (CSI) at Month 6	-0.55 units on a scale Standard Deviation 2.58

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The GADS is an 18-item self-report symptom inventory made up of two sub-scales, one for the detection of anxiety and another one for the detection of depression. Both sub-scales are composed of 9 questions. Answers are in yes/no format. Scoring is 1 point for each "yes" and 0 for each "no", with a total sub-scale score of 0 (no anxiety/depression) to 9 (worst anxiety/depression). In the Spanish validation of GADS, the cutoff point to consider probable anxiety disorder is 4 and 2 for probable depression.

Outcome measures

Measure	All Participants n=10 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in Goldberg Anxiety and Depression Score (GADS): Depression Sub-Scale for Caregivers at Month 6	0.20 units on a scale Standard Deviation 2.35

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The GADS is an 18-item self-report symptom inventory made up of two sub-scales, one for the detection of anxiety and another one for the detection of depression. Both sub-scales are composed of 9 questions. Answers are in yes/no format. Scoring is 1 point for each "yes" and 0 for each "no", with a total sub-scale score of 0 (no anxiety/depression) to 9 (worst anxiety/depression). In the Spanish validation of GADS, the cutoff point to consider probable anxiety disorder is 4 and 2 for probable depression.

Outcome measures

Measure	All Participants n=10 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in Goldberg Anxiety and Depression Score (GADS): Anxiety Sub-Scale for Caregivers at Month 6	-1.10 units on a scale Standard Deviation 0.99

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

Absenteeism, presented as the mean percentage of work time missed due to caregiving (as reported on the WPAI), and calculated as: 100*number of hours of work missed due to caregiving / (number of hours of work missed due to caregiving + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

Outcome measures

Measure	All Participants n=9 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) at Month 6	-7.56 percentage of work time missed Standard Deviation 40.68

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

Presenteeism (the extent to which caregiving decreased productivity) is presented as the mean percentage of impairment while working due to caregiving, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

Outcome measures

Measure	All Participants n=9 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Caregiving (Presenteeism)	0.00 percentage of work impairment Standard Deviation 18.03

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

The mean percentage of OWPI due to caregiving (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which caregiving decreased productivity (%)* [number of hours worked / (number of hours of work missed due to caregiving + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.

Outcome measures

Measure	All Participants n=9 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to Caregiving	-6.69 percentage of overall work impairment Standard Deviation 42.34

SECONDARY outcome

Timeframe: Baseline, Month 6 (±15 days)

Population: Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.

Activity impairment due to caregiving (the extent to which caregiving affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity/activity and 100% representing complete impact on productivity/activity.

Outcome measures

Measure	All Participants n=9 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Caregiving	-3.33 percentage of activity impairment Standard Deviation 22.91

SECONDARY outcome

Timeframe: Baseline

Population: Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline assessments.

Spearman correlation statistics were calculated for the quality of life of the participants (Global PDQ-39, see Outcome Measure 1) and the following scales: UPDRS-III (see Outcome Measure 10), UPDRS-IV (see description below), NMSS (see Outcome Measure 11), BAI (see Outcome Measure 28), BDI-III (see Outcome Measure 27), AS (see Outcome Measure 26), PFS (see Outcome Measure 25), Norris Bond-Lader (NBL) Alertness-Sedation (A-S; see Outcome Measure 22), NBL Contented-Discontented (C-D; see Outcome Measure 23), NBL Calm-Relaxed (C-R; see Outcome Measure 24), ZBI (see Outcome Measure 40), GADS-Anxiety (see Outcome Measure 43), and GADS-Depression (see Outcome Measure 42).

The UPDRS-IV contains 11 items, each scored in a Likert scale from 0 (normal) to 4 (severe); or a 2-point scale (yes/no format), with 1 point for "yes" and 0 for "no." The global score was calculated summing the score of each item, ranging from 0 to 23, where higher scores are associated with more disability.

Outcome measures

Measure	All Participants n=58 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline PDQ-39 with UPDRS-III	0.27148 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline PDQ-39 with UPDRS-IV	0.07346 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline PDQ-39 with NMSS	0.20994 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline PDQ-39 with BAI	0.28271 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline PDQ-39 with BDI-II	0.46174 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline PDQ-39 with AS	0.08846 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline PDQ-39 with PFS	0.33361 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline PDQ-39 with NBL A-S	0.22085 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline PDQ-39 with NBL C-D	0.35742 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline PDQ-39 with NBL C-R	0.00011 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline PDQ-39 with ZBI	-0.35125 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline PDQ-39 with GADS-Anxiety	0.21311 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline PDQ-39 with GADS-Depression	0.51846 correlation coefficient

SECONDARY outcome

Timeframe: Month 6 (±15 days)

Population: Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and Month 6 assessments.

Spearman correlation statistics were calculated for the quality of life of the participants (Global PDQ-39, see Outcome Measure 1) and the following scales: UPDRS-III (see Outcome Measure 10), UPDRS-IV (see description below), NMSS (see Outcome Measure 11), BAI (see Outcome Measure 28), BDI-III (see Outcome Measure 27), AS (see Outcome Measure 26), PFS (see Outcome Measure 25), Norris Bond-Lader (NBL) Alertness-Sedation (A-S; see Outcome Measure 22), NBL Contented-Discontented (C-D; see Outcome Measure 23), NBL Calm-Relaxed (C-R; see Outcome Measure 24), ZBI (see Outcome Measure 40), GADS-Anxiety (see Outcome Measure 43), and GADS-Depression (see Outcome Measure 42).

The UPDRS-IV contains 11 items, each scored in a Likert scale from 0 (normal) to 4 (severe); or a 2-point scale (yes/no format), with 1 point for "yes" and 0 for "no." The global score was calculated summing the score of each item, ranging from 0 to 23, where higher scores are associated with more disability.

Outcome measures

Measure	All Participants n=53 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6 PDQ-39 with UPDRS-III	0.30902 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6 PDQ-39 with UPDRS-IV	0.35220 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6 PDQ-39 with NMSS	0.36814 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6 PDQ-39 with BAI	0.60620 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6 PDQ-39 with BDI-II	0.56325 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6 PDQ-39 with AS	0.23657 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6 PDQ-39 with PFS	0.58572 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6 PDQ-39 with NBL A-S	0.54139 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6 PDQ-39 with NBL C-D	0.54140 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6 PDQ-39 with NBL C-R	0.38968 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6 PDQ-39 with ZBI	-0.32445 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6 PDQ-39 with GADS-Anxiety	0.56873 correlation coefficient
Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6 PDQ-39 with GADS-Depression	0.10855 correlation coefficient

SECONDARY outcome

Timeframe: Baseline

Population: Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline assessments.

Spearman correlation statistics were calculated for the quality of life of the caregivers (Global SQLC, see Outcome Measure ) and the following scales: ZBI (see Outcome Measure 40), GADS-Anxiety (see Outcome Measure 43), and GADS-Depression (see Outcome Measure 42), NBL A-S (see Outcome Measure 22), NBL C-D (see Outcome Measure 23), NBL C-R (see Outcome Measure 24), Global PDQ-39 (see Outcome Measure 1), UPDRS-III (see Outcome Measure 10), UPDRS-IV (see description below), and Global NMSS (see Outcome Measure 11).

The UPDRS-IV contains 11 items, each scored in a Likert scale from 0 (normal) to 4 (severe); or a 2-point scale (yes/no format), with 1 point for "yes" and 0 for "no." The global score was calculated summing the score of each item, ranging from 0 to 23, where higher scores are associated with more disability.

Outcome measures

Measure	All Participants n=54 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Baseline SQLC with ZBI	-0.51735 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Baseline SQLC with GADS-Anxiety	-0.16188 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Baseline SQLC with GADS-Depression	-0.44739 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Baseline SQLC with NBL A-S	0.06318 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Baseline SQLC with NBL C-D	0.17492 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Baseline SQLC with NBL C-R	0.28618 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Baseline SQLC with Global PDQ-39	-0.35125 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Baseline SQLC with UPDRS-III	-0.13353 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Baseline SQLC with UPDRS-IV	0.17659 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Baseline SQLC with Global NMSS	0.01625 correlation coefficient

SECONDARY outcome

Timeframe: Month 6 (±15 days)

Population: Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed Month 6 assessments.

Spearman correlation statistics were calculated for the quality of life of the caregivers (Global SQLC, see Outcome Measure ) and the following scales: ZBI (see Outcome Measure 40), GADS-Anxiety (see Outcome Measure 43), and GADS-Depression (see Outcome Measure 42), NBL A-S (see Outcome Measure 22), NBL C-D (see Outcome Measure 23), NBL C-R (see Outcome Measure 24), Global PDQ-39 (see Outcome Measure 1), UPDRS-III (see Outcome Measure 10), UPDRS-IV (see description below), and Global NMSS (see Outcome Measure 11).

The UPDRS-IV contains 11 items, each scored in a Likert scale from 0 (normal) to 4 (severe); or a 2-point scale (yes/no format), with 1 point for "yes" and 0 for "no." The global score was calculated summing the score of each item, ranging from 0 to 23, where higher scores are associated with more disability.

Outcome measures

Measure	All Participants n=48 Participants LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Month 6 SQLC with ZBI	-0.63324 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Month 6 SQLC with GADS Anxiety	0.17735 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Month 6 SQLC with GADS Depression	-0.06976 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Month 6 SQLC with NBL A-S	-0.11015 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Month 6 SQLC with NBL C-D	0.00326 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Month 6 SQLC with NBL C-R	-0.10256 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Month 6 SQLC with Global PDQ-39	-0.32445 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Month 6 SQLC with UPDRS-III	-0.23226 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Month 6 SQLC with UPDRS-IV	-0.12942 correlation coefficient
Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Month 6 SQLC with Global NMSS	0.11635 correlation coefficient

Adverse Events

All Participants

Serious events: 18 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants n=59 participants at risk LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson's disease with motor fluctuation not well responding to conventional therapies.
Cardiac disorders Acute myocardial infarction	1.7% 1/59 • Serious adverse events were reported from the time the physician obtained the participant's informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean treatment duration was 6.14 ± 1.10 months (median 6.38 months). Non-serious adverse events were not collected in this observational study, per protocol.
Cardiac disorders Angina unstable	1.7% 1/59 • Serious adverse events were reported from the time the physician obtained the participant's informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean treatment duration was 6.14 ± 1.10 months (median 6.38 months). Non-serious adverse events were not collected in this observational study, per protocol.
Cardiac disorders Atrial fibrillation	1.7% 1/59 • Serious adverse events were reported from the time the physician obtained the participant's informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean treatment duration was 6.14 ± 1.10 months (median 6.38 months). Non-serious adverse events were not collected in this observational study, per protocol.
Cardiac disorders Cardiac failure	1.7% 1/59 • Serious adverse events were reported from the time the physician obtained the participant's informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean treatment duration was 6.14 ± 1.10 months (median 6.38 months). Non-serious adverse events were not collected in this observational study, per protocol.
Cardiac disorders Ventricular tachycardia	1.7% 1/59 • Serious adverse events were reported from the time the physician obtained the participant's informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean treatment duration was 6.14 ± 1.10 months (median 6.38 months). Non-serious adverse events were not collected in this observational study, per protocol.
Gastrointestinal disorders Femoral hernia incarcerated	1.7% 1/59 • Serious adverse events were reported from the time the physician obtained the participant's informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean treatment duration was 6.14 ± 1.10 months (median 6.38 months). Non-serious adverse events were not collected in this observational study, per protocol.
Gastrointestinal disorders Gastroduodenal ulcer	1.7% 1/59 • Serious adverse events were reported from the time the physician obtained the participant's informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean treatment duration was 6.14 ± 1.10 months (median 6.38 months). Non-serious adverse events were not collected in this observational study, per protocol.
Gastrointestinal disorders Ileus paralytic	1.7% 1/59 • Serious adverse events were reported from the time the physician obtained the participant's informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean treatment duration was 6.14 ± 1.10 months (median 6.38 months). Non-serious adverse events were not collected in this observational study, per protocol.
Gastrointestinal disorders Pneumoperitoneum	6.8% 4/59 • Serious adverse events were reported from the time the physician obtained the participant's informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean treatment duration was 6.14 ± 1.10 months (median 6.38 months). Non-serious adverse events were not collected in this observational study, per protocol.
Infections and infestations Infection	1.7% 1/59 • Serious adverse events were reported from the time the physician obtained the participant's informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean treatment duration was 6.14 ± 1.10 months (median 6.38 months). Non-serious adverse events were not collected in this observational study, per protocol.
Injury, poisoning and procedural complications Cervical vertebral fracture	1.7% 1/59 • Serious adverse events were reported from the time the physician obtained the participant's informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean treatment duration was 6.14 ± 1.10 months (median 6.38 months). Non-serious adverse events were not collected in this observational study, per protocol.
Injury, poisoning and procedural complications Scapula fracture	1.7% 1/59 • Serious adverse events were reported from the time the physician obtained the participant's informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean treatment duration was 6.14 ± 1.10 months (median 6.38 months). Non-serious adverse events were not collected in this observational study, per protocol.
Nervous system disorders Peripheral sensory neuropathy	1.7% 1/59 • Serious adverse events were reported from the time the physician obtained the participant's informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean treatment duration was 6.14 ± 1.10 months (median 6.38 months). Non-serious adverse events were not collected in this observational study, per protocol.
Psychiatric disorders Substance-induced psychotic disorder	1.7% 1/59 • Serious adverse events were reported from the time the physician obtained the participant's informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean treatment duration was 6.14 ± 1.10 months (median 6.38 months). Non-serious adverse events were not collected in this observational study, per protocol.
Psychiatric disorders Withdrawal syndrome	1.7% 1/59 • Serious adverse events were reported from the time the physician obtained the participant's informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean treatment duration was 6.14 ± 1.10 months (median 6.38 months). Non-serious adverse events were not collected in this observational study, per protocol.

Other adverse events

Adverse event data not reported

Additional Information

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