Abbott has announced the Phase 3 study results of its levodopa-carbidopa intestinal gel (LCIG), used for the treatment of advanced Parkinson’s Disease (PD).
LCIG is administered via a procedurally-implanted tube connected to a portable pump which delivers the medication directly into the small intestine, providing a continuous delivery of medication during the 16 hours a day of pump use.
The 12-week double-blind double-dummy multi-site trial compared the efficacy, safety and tolerability of continuous LCIG infusion to standard levodopa-carbidopa immediate release (IR) tablets.
The study’s primary efficacy endpoint was change from baseline in daily off time (16 waking hours) at 12 weeks, and the secondary efficacy endpoint was change from baseline in daily on time which refers to periods of good motor symptom control without troublesome dyskinesias.
LCIG showed decrease in off time by 4 hours a day and increase in on time by 4.1 hours per day in the study. Mount Sinai School of Medicine, New York, US, Neurology and Neuroscience professor C.W. Olanow said the results demonstrated that continuous delivery of LCIG produces meaningful improvements in advanced PD patients by decreasing ‘off’ time and increasing ‘on’ time without troublesome dyskinetic symptoms.
“These benefits in a patient group that cannot be satisfactorily controlled with standard levodopa, represent an important step forward in our efforts to treat advanced PD patients,” Olanow added.