Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients

Parkinson Disease Clinical Trial

Official title: An Open Label Phase 2 Study to Assess the Pharmacokinetics of the Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Patients With Parkinson's Disease

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study is to assess the PK of AP-CD/LD given at dose of 50/500mg three times daily compared to CD/LD immediate release (Sinemet) 1.5 tablets of dose of 25/100 given 5 times per day in Parkinson's Disease patients.

Clinical Trial Description

An open label, non randomized crossover phase 2 study to assess the PK of AP-CD/LD given at dose of 50/500mg three times daily compared to CD/LD immediate release (Sinemet) 1.5 tablets of dose of 25/100 given 5 times per day in Parkinson's Disease patients. The study will have a screening period followed by an overnight stay in clinic where Immediate release CD/LD (Sinemet) will be administered five times, approximately every three hours. At specified intervals, blood will be drawn for PK testing. On Days 2-7, subjects will be treated at home with AP CD/LD three times/day, approximately every five hours. Day 8 will be overnight stay in clinic for PK study. AP CD/LD 500mg TID will be dispensed to subjects with specified timelines for PK assessment. Each subject will return to clinic on day 15 for a safety followup visit. ;

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT03576638
• Study type: Interventional
• Source: Intec Pharma Ltd.
• Contact: Fabrizio Stocchi, MD, PhD
• Phone: +39 0652252311
• Email: fabrizio.stocchi@sanraffaele.it
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2018
• Completion date: January 2019