drugset / Trial / NCT02605434

A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients

NCT02605434

Phase 3 Unknown 420 enrolled Intec Pharma Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether the gastric retentive Accordion Pill™ 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.

Timeline

Start
2016-03
Primary completion
2019-07
Completion
2019-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Carbidopa Unknown 25 mg Oral
Subject Carbidopa Unknown 50 mg Oral
Subject Levodopa Small molecule 100 mg Oral
Subject Levodopa Small molecule 400 mg Oral
Subject Levodopa Small molecule 500 mg Oral

Indications