Intec Pharma has completed patient enrolment in the Phase III ACCORDANCE trial investigating the safety and efficacy of accordion pill carbidopa / levodopa (AP-CD/LD) in comparison with CD/LD (IR-CD/LD; sinemet) as a treatment for the symptoms of advanced Parkinson's disease (PD).
The active-controlled, double-blinded, double-dummy trial is being conducted at around 90 clinical sites across the US, Europe and Israel.
During the sinemet titration period, the parallel-group trial enrolled 462 patients, and aims to randomise around 300 patients into its double-blinded portion.
The trial's primary efficacy objective is the change from baseline to endpoint in the percent of daily OFF time during waking hours.
Secondary objectives include change from baseline to endpoint in ON time without troublesome dyskinesia during waking hours and clinical global impression scale-improvement (CGI-I) at endpoint.
Intec Pharma chief medical officer Michael Gendreau said: “The complications associated with advanced PD have a substantial impact on healthcare costs and quality-of-life.
“By providing more uniform levodopa plasma concentrations than those provided by currently available orally administered levodopa products, we expect to improve the duration and consistency of symptom relief provided by levodopa with a simpler dosing regimen.
“We believe the simplified dosing regimen in a baseline levodopa therapy will result in improved motor fluctuation control, reduced symptomology and enhanced compliance.”
Intec Pharma has already carried out the preliminary analysis of the baseline data for enrolled patients in the ACCORDANCE trial.
The analysis demonstrated that the average age of patients at entry was 63, with 65% being male. On average, patients had a diagnosis of PD for 8.8 years.