Trial Outcomes & Findings for A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD) (NCT NCT02549092)

Last Updated: 2023-11-28

Results Overview

The NMSS consists of 30 questions in 9 domains (cardiovascular/falls, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, GI tract, urinary, sexual function, miscellaneous). Score of each question is calculated by multiplying severity\*frequency. Severity and frequency are rated using a scale ranging from 0 (none) to 3 (severe) for severity and from 1 (rarely) to 4 (very frequent) for frequency. Total score is the sum of 9 domains, and ranges from 0 to 360, with a lower value indicating a more desirable outcome. Repeated-measure analysis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

89 participants

Primary outcome timeframe

Baseline, Week 26

Results posted on

2023-11-28

Participant Flow

This study was conducted at 32 sites in 9 countries.

After a 30- to 67-day Screening Period for required procedures, training, and medication stabilization, eligible participants were randomized to Optimized Medical Treatment (OMT) or Levodopa-Carbidopa Intestinal Gel (LCIG) for a 26-week Treatment Period. Before Treatment Period Day 1, LCIG participants had a percutaneous endoscopic gastrostomy with a jejunal extension (PEG-J; with an initial, optional, temporary nasojejunal \[NJ\] tube placement to titrate the dose of LCIG prior to the PEG-J).

Participant milestones

Participant milestones
Measure	Optimized Medical Treatment Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated. Participants in the United States or South Korea may have elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose (after NJ and/or PEG-J placement), in order to transition to commercially available LCIG.	LCIG Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day. Participants in the United States or South Korea may have elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose, in order to transition to commercially available LCIG.
Treatment Period STARTED	44	45
Treatment Period COMPLETED	41	38
Treatment Period NOT COMPLETED	3	7
Extension/Transition Period STARTED	10	14
Extension/Transition Period Transitioned to Commercial LCIG	5	7
Extension/Transition Period COMPLETED	5	10
Extension/Transition Period NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Optimized Medical Treatment Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated. Participants in the United States or South Korea may have elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose (after NJ and/or PEG-J placement), in order to transition to commercially available LCIG.	LCIG Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day. Participants in the United States or South Korea may have elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose, in order to transition to commercially available LCIG.
Treatment Period Adverse Event	2	2
Treatment Period Withdrawal by Subject	1	3
Treatment Period Lack of Efficacy	0	2
Extension/Transition Period Adverse Event	1	1
Extension/Transition Period Withdrawal by Subject	0	1
Extension/Transition Period Other, Not Specified	4	2

Baseline Characteristics

Intent-to-Treat Data Set: all participants randomized to the OMT arm, and all participants randomized to LCIG arm who received at least one dose of study drug. Participants with a baseline measurement are reported in this table.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Optimized Medical Treatment n=44 Participants Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated. Participants in the United States or South Korea may have elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose (after NJ and/or PEG-J placement), in order to transition to commercially available LCIG.	LCIG n=43 Participants Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day. Participants in the United States or South Korea may have elected to enter an Extension/Transition follow-up period to receive an individually optimized LCIG dose, in order to transition to commercially available LCIG.	Total n=87 Participants Total of all reporting groups
Age, Continuous	68.6 years STANDARD_DEVIATION 6.21 • n=44 Participants	66.9 years STANDARD_DEVIATION 7.34 • n=43 Participants	67.8 years STANDARD_DEVIATION 6.81 • n=87 Participants
Sex: Female, Male Female	20 Participants n=44 Participants	14 Participants n=43 Participants	34 Participants n=87 Participants
Sex: Female, Male Male	24 Participants n=44 Participants	29 Participants n=43 Participants	53 Participants n=87 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=44 Participants	7 Participants n=43 Participants	16 Participants n=87 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=44 Participants	36 Participants n=43 Participants	71 Participants n=87 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=44 Participants	0 Participants n=43 Participants	0 Participants n=87 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=44 Participants	0 Participants n=43 Participants	0 Participants n=87 Participants
Race (NIH/OMB) Asian	9 Participants n=44 Participants	8 Participants n=43 Participants	17 Participants n=87 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=44 Participants	0 Participants n=43 Participants	0 Participants n=87 Participants
Race (NIH/OMB) Black or African American	0 Participants n=44 Participants	1 Participants n=43 Participants	1 Participants n=87 Participants
Race (NIH/OMB) White	35 Participants n=44 Participants	34 Participants n=43 Participants	69 Participants n=87 Participants
Race (NIH/OMB) More than one race	0 Participants n=44 Participants	0 Participants n=43 Participants	0 Participants n=87 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=44 Participants	0 Participants n=43 Participants	0 Participants n=87 Participants
Non-Motor Symptoms Scale (NMSS) Total Score	112.4 score on a scale STANDARD_DEVIATION 51.37 • n=43 Participants • Intent-to-Treat Data Set: all participants randomized to the OMT arm, and all participants randomized to LCIG arm who received at least one dose of study drug. Participants with a baseline measurement are reported in this table.	99.7 score on a scale STANDARD_DEVIATION 46.49 • n=42 Participants • Intent-to-Treat Data Set: all participants randomized to the OMT arm, and all participants randomized to LCIG arm who received at least one dose of study drug. Participants with a baseline measurement are reported in this table.	106.2 score on a scale STANDARD_DEVIATION 49.14 • n=85 Participants • Intent-to-Treat Data Set: all participants randomized to the OMT arm, and all participants randomized to LCIG arm who received at least one dose of study drug. Participants with a baseline measurement are reported in this table.
Modified Parkinson's Disease Sleep Scale (PDSS-2) Total Score	30.3 score on a scale STANDARD_DEVIATION 8.55 • n=43 Participants • Intent-to-Treat Data Set: all participants randomized to the OMT arm, and all participants randomized to LCIG arm who received at least one dose of study drug. Participants with a baseline measurement are reported in this table.	29.9 score on a scale STANDARD_DEVIATION 7.36 • n=42 Participants • Intent-to-Treat Data Set: all participants randomized to the OMT arm, and all participants randomized to LCIG arm who received at least one dose of study drug. Participants with a baseline measurement are reported in this table.	30.1 score on a scale STANDARD_DEVIATION 7.94 • n=85 Participants • Intent-to-Treat Data Set: all participants randomized to the OMT arm, and all participants randomized to LCIG arm who received at least one dose of study drug. Participants with a baseline measurement are reported in this table.

PRIMARY outcome

Timeframe: Baseline, Week 26

Population: Intent-to-Treat Data Set: all participants who were randomized to the OMT arm, and all participants who were randomized to LCIG arm and received at least one dose of study drug. Participants with baseline and a post-baseline measurement are reported in this table.

Outcome measures

Outcome measures
Measure	Optimized Medical Treatment n=43 Participants Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.	LCIG n=42 Participants Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day.
Change From Baseline to Week 26 in the NMSS Total Score	-23.83 score on a scale Standard Error 8.30	-32.04 score on a scale Standard Error 8.53

PRIMARY outcome

Timeframe: Baseline, Week 26

The PDSS-2 addresses PD-specific sleep disturbances such as restless leg syndrome (RLS), morning akinesia, pain, and sleep apnea. The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 \[never\] to 4 \[very often\]). Scores are calculated for each of the 3 domains (motor symptoms at night, PD symptoms at night, and disturbed sleep) as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Repeated measure analysis.

Outcome measures

Outcome measures
Measure	Optimized Medical Treatment n=43 Participants Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.	LCIG n=42 Participants Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day.
Change From Baseline to Week 26 in the Modified PDSS-2 Total Score	-8.98 score on a scale Standard Error 2.00	-7.41 score on a scale Standard Error 2.01

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Intent-to-Treat Data Set: all participants who were randomized to the OMT arm, and all participants who were randomized to LCIG arm and received at least one dose of study drug.

The PDQ-8 is a disease-specific instrument designed to measure aspects of health relevant to PD. Eight questions including the mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort are assessed on a 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable). Summary index score is the sum of each question divided by 32 and multiplied by 100. Scores range from 0 to 100 with lower values desirable.

Outcome measures

Outcome measures
Measure	Optimized Medical Treatment n=44 Participants Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.	LCIG n=43 Participants Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day.
Change From Baseline to Week 26 in Parkinson's Disease Questionnaire (PDQ-8) Summary Index Score	-1.75 score on a scale Standard Error 2.96	-5.56 score on a scale Standard Error 2.97

SECONDARY outcome

Timeframe: End of Treatment Period (up to Week 26)

CGI-C score is a clinician's impression of a subject's change in status on a 7-point scale (1 = very much improved, 2 = much improved, 3 = minimally Improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse). Scores range from 1 to 7, with lower score desirable.

Outcome measures

Outcome measures
Measure	Optimized Medical Treatment n=43 Participants Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.	LCIG n=40 Participants Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day.
Clinical Global Impression of Change (CGI-C) Final Score	4.9 score on a scale Standard Error 0.25	2.5 score on a scale Standard Error 0.24

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Intent-to-Treat Data Set: all participants who were randomized to the OMT arm, and all participants who were randomized to LCIG arm and received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Optimized Medical Treatment n=44 Participants Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.	LCIG n=43 Participants Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day.
Change From Baseline at Week 26 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score	0.53 score on a scale Standard Error 0.89	-2.26 score on a scale Standard Error 0.87

SECONDARY outcome

Timeframe: Baseline, Week 26

The NMSS consists of 30 questions in 9 domains. Score of each question is calculated by multiplying severity\*frequency. Severity and frequency are rated using a scale ranging from 0 (none) to 3 (severe) for severity and from 1 (rarely) to 4 (very frequent) for frequency. Cardiovascular/falls scores range from 0 - 24 with lower value desirable. Sleep/fatigue scores range from 0 - 48 with lower value desirable. Mood/cognition scores range from 0 - 72 with lower value desirable. Perceptual problems/hallucinations scores range from 0 - 36 with lower value desirable. Attention/memory scores range from 0 - 36 with lower value desirable. Gastrointestinal tract scores range from 0 - 36 with lower value desirable. Urinary scores range from 0 - 36 with lower value desirable. Sexual function scores range from 0 - 24 with lower value desirable. Miscellaneous scores range from 0 - 48 with lower value desirable. Repeated-measure analysis.

Outcome measures

Outcome measures
Measure	Optimized Medical Treatment n=43 Participants Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.	LCIG n=42 Participants Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day.
Change From Baseline to Week 26 in the NMSS Domain Scores Cardiovascular including falls	-1.84 score on a scale Standard Error 0.82	-1.76 score on a scale Standard Error 0.86
Change From Baseline to Week 26 in the NMSS Domain Scores Sleep/fatigue	-7.11 score on a scale Standard Error 2.02	-6.06 score on a scale Standard Error 2.06
Change From Baseline to Week 26 in the NMSS Domain Scores Mood/cognition	-5.99 score on a scale Standard Error 3.06	-7.84 score on a scale Standard Error 3.11
Change From Baseline to Week 26 in the NMSS Domain Scores Perceptual problems/hallucinations	-1.53 score on a scale Standard Error 0.70	-1.14 score on a scale Standard Error 0.72
Change From Baseline to Week 26 in the NMSS Domain Scores Attention/memory	-1.20 score on a scale Standard Error 1.60	-2.15 score on a scale Standard Error 1.66
Change From Baseline to Week 26 in the NMSS Domain Scores Gastrointestinal tract	-0.85 score on a scale Standard Error 1.09	-3.43 score on a scale Standard Error 1.14
Change From Baseline to Week 26 in the NMSS Domain Scores Urinary	-3.65 score on a scale Standard Error 1.90	-4.83 score on a scale Standard Error 1.96
Change From Baseline to Week 26 in the NMSS Domain Scores Sexual function	0.88 score on a scale Standard Error 0.86	0.10 score on a scale Standard Error 0.90
Change From Baseline to Week 26 in the NMSS Domain Scores Miscellaneous	-3.87 score on a scale Standard Error 1.53	-5.16 score on a scale Standard Error 1.60

SECONDARY outcome

Timeframe: Baseline, Week 26

Outcome measures

Outcome measures
Measure	Optimized Medical Treatment n=43 Participants Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.	LCIG n=42 Participants Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day.
Change From Baseline to Week 26 in the Modified PDSS-2 Domain Scores Motor symptoms at night	-2.21 score on a scale Standard Error 1.04	-2.79 score on a scale Standard Error 1.05
Change From Baseline to Week 26 in the Modified PDSS-2 Domain Scores PD symptoms at night	-1.77 score on a scale Standard Error 0.66	-1.53 score on a scale Standard Error 0.69
Change From Baseline to Week 26 in the Modified PDSS-2 Domain Scores Disturbed sleep	-4.88 score on a scale Standard Error 0.74	-2.89 score on a scale Standard Error 0.75

SECONDARY outcome

Timeframe: Baseline, Week 26

UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease of 42 total questions. Part I (Questions 1 - 4), Part II (Questions 5 - 17), Part III (Questions 18 - 31), and Part IV (Questions 32 - 42). Questions 35 - 38 and 40 - 42 are 2-point (0 and 1), all other questions are 5-point (0 - 4). Part I is the sum of Questions 1 - 4; scores range from 0 to 16 with lower value desirable. Part III is the sum of Questions 18 - 31 (Questions 20 - 26 apply to multiple body parts, resulting in 27 answers total); scores range from 0 to 108 with lower value desirable. Part IV is the sum of Questions 32 - 42; scores range from 0 to 23 with lower value desirable.

Outcome measures

Outcome measures
Measure	Optimized Medical Treatment n=44 Participants Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.	LCIG n=43 Participants Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day.
Change From Baseline at Week 26 in UPDRS Parts I, III, and IV Score Part I	0.20 score on a scale Standard Error 0.39	0.39 score on a scale Standard Error 0.39
Change From Baseline at Week 26 in UPDRS Parts I, III, and IV Score Part III	1.32 score on a scale Standard Error 1.84	-0.89 score on a scale Standard Error 1.80
Change From Baseline at Week 26 in UPDRS Parts I, III, and IV Score Part IV	-0.61 score on a scale Standard Error 0.53	-2.31 score on a scale Standard Error 0.52

SECONDARY outcome

Timeframe: Baseline, Week 26

PAS is a 12-item scale developed specifically to measure severity in anxiety in Parkinson's disease for the following items: Feeling anxious or nervous; Feeling tense or stressed; Being unable to relax; Excessive worrying about everyday matters; Fear of something bad, or even the worst, happening; Panic or intense fear; Shortness of breath; Heart palpitations or heart beating fast; Fear of losing control; Social situations; Public settings; Specific objects or situations. Severity for each item is rated as: 0, Never; 1 Rarely; 2, Sometimes; 3, Often; 4, Nearly always. Total score is the sum of the12 item scores, with a range of 0 to 48; a lower value is desirable.

Outcome measures

Outcome measures
Measure	Optimized Medical Treatment n=44 Participants Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.	LCIG n=41 Participants Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day.
Change From Baseline at Week 26 in Parkinson's Anxiety Scale (PAS) Total Score	-0.75 score on a scale Standard Error 1.28	-2.29 score on a scale Standard Error 1.27

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Intent-to-Treat Data Set: all participants who were randomized to the OMT arm, and all participants who were randomized to LCIG arm and received at least one dose of study drug.

The GDS-15 is a short, self-report reliable and valid screening instrument for depression in the elderly of 15 yes/no questions: 1) Satisfied with life 2) Dropped many activities and interests 3) Life is empty 4) Often get bored 5) In good spirits most of the time 6) Afraid that something bad is going to happen 7) Feel happy most of the time 8) Often feel helpless 9) Prefer to stay at home, rather than going out and doing things 10) Feel that have more problems with memory than most 11) Think it is wonderful to be alive now 12) Feel worthless 13) Feel full of energy 14) Situation is hopeless 15) Most subjects are better off. Answers of 'yes' to questions 2, 3, 4, 6, 8, 9, 10, 12, 14, 15 are scored 1 point. Answers of 'no' to questions 1, 5, 7, 11, 13 are scored 1 point. The 15 items are summed and scores range from 0 - 15 with lower value desirable.

Outcome measures

Outcome measures
Measure	Optimized Medical Treatment n=44 Participants Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.	LCIG n=43 Participants Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day.
Change From Baseline at Week 26 in Geriatric Depression Scale (GDS-15) Score	0.25 score on a scale Standard Error 0.40	0.17 score on a scale Standard Error 0.39

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Intent-to-Treat Data Set: all participants who were randomized to the OMT arm, and all participants who were randomized to LCIG arm and received at least one dose of study drug.

The KPPS score is a clinical PD-specific pain scale of 14 items addressing the following 7 domains: musculoskeletal pain, chronic pain, fluctuation-related pain, nocturnal pain, orofacial pain, neuropathic pain, radicular pain. Each domain item is scored by severity (0, none to 3, very severe) multiplied by frequency (0, never to 4, all the time) resulting in a subscore of 0 - 12 (with lower value desirable), the sum of the 14 items gives the total score with a range from 0 to 168 with lower value desirable.

Outcome measures

Outcome measures
Measure	Optimized Medical Treatment n=44 Participants Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.	LCIG n=43 Participants Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day.
Change From Baseline at Week 26 in King's PD Pain Scale (KPPS) Score Total score	-11.32 score on a scale Standard Error 2.83	-12.46 score on a scale Standard Error 2.77
Change From Baseline at Week 26 in King's PD Pain Scale (KPPS) Score Musculoskeletal Pain Score	-1.72 score on a scale Standard Error 0.63	-1.79 score on a scale Standard Error 0.62
Change From Baseline at Week 26 in King's PD Pain Scale (KPPS) Score Chronic pain score	-0.84 score on a scale Standard Error 0.54	-0.77 score on a scale Standard Error 0.55
Change From Baseline at Week 26 in King's PD Pain Scale (KPPS) Score Fluctuation related pain score	-3.77 score on a scale Standard Error 1.30	-3.14 score on a scale Standard Error 1.28
Change From Baseline at Week 26 in King's PD Pain Scale (KPPS) Score Nocturnal pain score	-2.41 score on a scale Standard Error 1.04	-2.78 score on a scale Standard Error 1.01
Change From Baseline at Week 26 in King's PD Pain Scale (KPPS) Score Orofacial pain score	-0.74 score on a scale Standard Error 0.41	-0.87 score on a scale Standard Error 0.41
Change From Baseline at Week 26 in King's PD Pain Scale (KPPS) Score Discoloration and edema score	-0.47 score on a scale Standard Error 0.65	-2.27 score on a scale Standard Error 0.65
Change From Baseline at Week 26 in King's PD Pain Scale (KPPS) Score Radicular pain score	-1.43 score on a scale Standard Error 0.39	-1.47 score on a scale Standard Error 0.39

SECONDARY outcome

Timeframe: End of Treatment Period (up to Week 26)

The PGIC is a 7-point response scale. The participant was asked by the Investigator or qualified designee to rate their change in status using the following 7-point scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. PGIC score ranges from 1 to 7 with lower score desirable.

Outcome measures

Outcome measures
Measure	Optimized Medical Treatment n=43 Participants Participants randomized to continue OMT remained on their current optimized regimen during the 26-week treatment phase. Changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated.	LCIG n=40 Participants Participants randomized to LCIG at an individually optimized dose, in accordance with the LCIG approved product label for countries participating in the study during the 26-week treatment phase. Changes to anti-PD and NMS medications were to remain stable and were only made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion was expected to run over a period of 16 consecutive hours each day.
Patient Global Impression of Change (PGIC) Final Score	4.9 score on a scale Standard Error 0.25	2.5 score on a scale Standard Error 0.24

Adverse Events

Optimized Medical Treatment (OMT)

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

LCIG

Serious events: 9 serious events

Other events: 33 other events

Deaths: 0 deaths

Extension/Transition OMT->LCIG

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

Extension/Transition LCIG->LCIG

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER