Abbott has reported the results from the Phase 3 trial evaluating its investigational compound levodopa-carbidopa intestinal gel (LCIG), used for the treatment of advanced Parkinson's disease (PD), a progressive and chronic movement disorder.
LCIG is administered via a procedurally-implanted tube connected to a portable pump that delivers the medication directly into the small intestine, where it is absorbed into the bloodstream, providing a continuous delivery of medication during the 16 hours a day of pump use.
The 12-week double-blind double-dummy multi-site efficacy and safety trial was intended to determine the efficacy, safety and tolerability of continuous LCIG infusion in patients with advanced PD compared to standard levodopa-carbidopa immediate release (IR) tablets.
The primary efficacy endpoint was a 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.
The study data showed that patients treated with LCIG reported a decrease in off time by four hours a day and increase in on time by 4.1 hours per day with LCIG treatment.
In the trial, primary efficacy outcomes were measured using the Parkinson's Disease Diary-derived parameters, while secondary outcomes were assessed using tools including the Parkinson's Disease Questionnaire (PDQ-39), Clinical Global Impression-Improvement (CGI-I) and Unified Parkinson's Disease Rating Scale (UPDRS) scores, parts two and three.
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.