Phase 3 Trial Update of Levodopa-Carbidopa Intestinal Gel for Advanced Parkinson's Disease
Abbott announced results from a Phase 3 trial evaluating the company's investigational compound for advanced Parkinson's disease, levodopa-carbidopa intestinal gel (LCIG).
The trial was a 12-week, double-blind, double-dummy, multi-site efficacy and safety study in patients with advanced Parkinson's disease and severe motor fluctuations despite optimized treatment with oral medications. In order to enroll, subjects had to be responsive to oral levodopa and experience a minimum of three hours of daily "off" time. "Off" time refers to the periods of poor mobility, slowness and stiffness experienced by patients with Parkinson's disease. This study was conducted to determine the efficacy, safety and tolerability of continuous LCIG infusion in patients with advanced Parkinson's disease compared to standard levodopa-carbidopa IR tablets.
LCIG was administered via a procedurally-implanted tube connected to a portable pump that delivered the medication directly into the small intestine, where it was absorbed into the bloodstream, providing a continuous delivery of medication during the 16 hours a day of pump use.
The primary efficacy endpoint was change from baseline in daily "off" time (16 waking hours) at 12 weeks. Mean "off" time at 12 weeks decreased by 4 hours per day with LCIG, an average of 1.91 fewer hours of "off" time compared to levodopa-carbidopa IR tablets. The secondary efficacy endpoint was change from baseline in daily "on" time without troublesome dyskinesias. "On" time refers to periods of good motor symptom control. Mean "on" time improved by 4.1 hours with LCIG, an average of 1.86 more hours compared to levodopa-carbidopa IR tablets.
LCIG contains the same active medication as levodopa-carbidopa IR tablets. Carbidopa is a dopa-decarboxylase inhibitor, while levodopa is a dopamine precursor.
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