Positive staining (brown) of an intraneural Lewy-body in the Substantia nigra in Parkinson’s disease. Credit: Marvin 101.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

“We expect to improve the duration and consistency of symptom relief provided by levodopa with a simpler dosing regimen.”

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.