Parkinson’s Disease / 2020 / Article / Tab 7

Research Article

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 programaMean (SD) change from baseline to the last visit
Levodopa <2000 mg/day (n = 253b)Levodopa ≥2000 mg/day (n = 54b)

“Off” time, hours–4.5 (2.8)–4.3 (3.1)
“On” time without TSD, hours4.9 (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 registryLevodopa <2000 mg/day (n = 178b)Levodopa ≥2000 mg/day (n = 29b)

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.

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