Abbott Laboratories has released positive results from a phase 3 clinical trial evaluating the company’s levodopa-carbidopa intestinal gel (LCIG) for the treatment of advanced Parkinson’s disease.
The study showed that patients treated with the investigational compound for 12 weeks reported significant improvements in ‘off’ periods of poor mobility and stiffness compared to levodopa-carbidopa immediate release tablets, without increasing dyskinesia symptoms.
LCIG contains the same active medication as levodopa-carbidopa IR tablets but in gel form and is administered directly into the small intestine via a procedurally-implanted tube.
Results of the research, which will be presented at the American Academy of Neurology’s annual meeting in New Orleans, Louisiana, next week, showed that the average ‘on’ time (periods of good motor symptom control) improved by 4.1 hours with LCIG, around 1.86 more hours compared to levodopa-carbidopa IR tablets.
Adverse events occurred in 34 out of the 35 patients using the gel, compared to 35 patients (100%) taking the tablets. The most common adverse events were complication of device insertion, abdominal pain, procedural pain, nausea, constipation, orthostatic hypotension, post-operative wound infection, and incision site erythema.
LCIG is approved in 40 countries outside the US.