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Clinical Trial Summary

The purpose of this study is to determine whether the gastric retentive Accordion Pillâ„¢ Carbidopa/Levodopa (AP-CD/LD) is more effective than the commercially available immediate release Carbidopa/Levodopa in reducing motor fluctuations such as "off time" in advanced Parkinson's Disease patients.


Clinical Trial Description

A multi-center, global, randomized, double-blind, double-dummy, active-controlled, parallel-group study in adult subjects with fluctuating PD. The study will have 2 open label Titration periods of 6 weeks each prior to the double blind Maintenance period. In the open label periods all patients will be stabilized on the active comparator Sinemet® and then on AP-CD/LD. The double blind Maintenance period will be 13 weeks long. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02605434
Study type Interventional
Source Intec Pharma Ltd.
Contact
Status Active, not recruiting
Phase Phase 3
Start date March 2016
Completion date December 2019

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