Effects of Levodopa-Carbidopa Intestinal Gel Compared with Optimized Medical Treatment on Nonmotor Symptoms in Advanced Parkinson’s Disease: INSIGHTS Study

Table 2

Primary and key secondary endpoints (intent-to-treat population).

Endpoints^†		Observed mean (SD)						Between-group comparisons (LCIG vs. OMT)
		Group	n ^‡	Baseline	Change to week 26	LS mean (SE)	Within-group value	LS mean (SE) of difference	95% CI	value
Primary	NMSS total score	LCIG	42	99.7 (46.5)	−30.7 (52.8)	−32.0 (8.5)	<0.001	−8.2 (9.9)	(−28.0, 11.6)	0.410
		OMT	43	112.4 (51.4)	−32.9 (64.3)	−23.8 (8.3)	0.005
	PDSS-2 total score	LCIG	42	29.9 (7.4)	−7.9 (11.4)	−7.4 (2.0)	<0.001	1.6 (2.4)	(−3.2, 6.3)	0.509
		OMT	43	30.3 (8.6)	−9.8 (12.8)	−9.0 (2.0)	<0.001
Key secondary	UPDRS part II (ADL) score	LCIG	43	16.7 (7.1)	−2.6 (5.7)	−2.3 (0.9)	0.012	−2.8 (1.0)	(−4.8, −0.8)	0.006
		OMT	44	17.5 (7.0)	−0.1 (4.7)	0.5 (0.9)	0.549
	PDQ-8 summary index	LCIG	43	39.7 (17.3)	−7.2 (18.3)	−5.6 (3.0)	0.064	−3.8 (3.6)	(−11.0, 3.3)	0.291
		OMT	44	44.5 (17.3)	−6.3 (19.6)	−1.8 (3.0)	0.556
	CGI-C score	LCIG	40		2.4 (1.2)	2.5 (0.2)	<0.001	−2.3 (0.3)	(−2.8, −1.8)	<0.001
		OMT	43		4.7 (1.2)	4.9 (0.3)	<0.001

^†Analyses for all continuous efficacy endpoints are for the change from baseline value (with the exception of CGI-C, which is the score at Week 26). Results for all efficacy variables are based on MMRM analysis with the exception of CGI-C which is based on the ANOVA model. ^‡Number of patients in the intent-to-treat dataset with the baseline value. Abbreviations: ADL: activities of daily living, ANOVA: analysis of variance, CGI-C: Clinical Global Impression of Change, CI: confidence interval, LCIG: levodopa-carbidopa intestinal gel, LS: least squares, MMRM: mixed-effects model repeated-measures, NMSS: Non-Motor Symptom Scale, OMT: optimized medical treatment, PDSS-2: Parkinson’s Disease Sleep Scale, PDQ-8: Parkinson’s Disease Questionnaire-8 item summary index, SD: standard deviation, SE: standard error, and UPDRS: Unified Parkinson’s Disease Rating Scale.