Safety of Levodopa-Carbidopa Intestinal Gel Treatment in Patients with Advanced Parkinson’s Disease Receiving ≥2000 mg Daily Dose of Levodopa

Table 7

Select efficacy outcomes.

Phase III program^a	Mean (SD) change from baseline to the last visit
	Levodopa <2000 mg/day (n = 253^b)	Levodopa ≥2000 mg/day (n = 54^b)
“Off” time, hours	–4.5 (2.8)	–4.3 (3.1)
“On” time without TSD, hours	4.9 (3.4)	4.5 (3.3)
“On” time with TSD, hours	–0.4 (2.8)	–0.2 (2.8)
UPDRS part II score	–4.6 (6.3)	–3.5 (7.0)
PDQ-39 summary index	–7.0 (13.4)	–6.7 (17.4)
GLORIA registry	Levodopa <2000 mg/day (n = 178^b)	Levodopa ≥2000 mg/day (n = 29^b)
Modified UPDRS part IV item 39: “Off” time, h	–3.8 (3.4)	–4.9 (4.2)
Modified UPDRS part IV item 32: “On” time with dyskinesia, h	–1.1 (4.7)	–1.3 (4.5)
UPDRS part II score	–0.9 (9.2)	–3.0 (8.2)
PDQ-8 summary index	–7.4 (20.0)	–5.2 (25.7)

“On”/“Off” time was normalized to a 16-hour waking day and averaged for the three days prior to each study visit. ^aEfficacy analyses include only data from patients enrolled in the 12-month open-label phase III study (study II); baseline values for this population were similar to those presented for the phase III program population in Table 1. ^bNumber of patients at the last visit. PDQ-8: Parkinson’s Disease Questionnaire-8; SD: standard deviation; TSD: troublesome dyskinesia; UPDRS: Unified Parkinson’s Disease Rating Scale.