Last Patient Fully Assessed in Trial of Accordion Formulation of Levodopa/Carbidopa for Parkinson’s Disease
The final patient completed their last physician visit in a pivotal phase 3 clinical trial for the accordion pill formulation of carbidopa/levodopa (AP-CD/LD) (Intec Pharma, Jerusalem, Israel) for treating advanced Parkinson’s disease (PD).
A gastric-retentive drug delivery system, AP-CD/LD that contains carbidopa and levodopa in both immediate- and extended-release modes. The medicine is released slowly in the stomach over 8-12 hours for a more stable and predictable pharmacokinetic profile.
The ACCORDANCE trial (NCT02605434) is a multi-center, global, randomized study in adult subjects with advanced PD. Prior to the 13-week randomized portion of the study were two open-label periods of 6 weeks each in which patients were stabilized and optimized on the active comparator, Sinemet (Merck, Kenilworth, NJ), and then on AP-CD/LD.
The primary efficacy endpoint of the study is the change from baseline to endpoint in OFF time during waking hours based on Hauser home diaries. Secondary endpoints include change from baseline to endpoint in ON time without troublesome dyskinesia during waking hours, and progress on Clinical Global Impressions—Improvement (CGI-I).
Clinical data and patient diaries are being validated and top-line results are expected in July or August. “Completion of the ACCORDANCE study brings us closer to potentially providing an enhanced baseline levodopa treatment to advanced PD patients,” said R. Michael Gendreau, MD, PhD, chief medical officer, Intec Pharma. “By delivering 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. Assuming successful ACCORDANCE study outcomes, we believe the AP-CD/LD will result in improved motor fluctuation control, reduced symptomology, a simpler dosing regimen, and enhanced compliance.”