drugset / Trial / NCT02615873

A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004

NCT02615873

Phase 3 Unknown 460 enrolled Intec Pharma Ltd.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to allow evaluation of long-term clinical effect and safety outcome of treatment with AP-CD/LD, as well as to allow patients to benefit from extended treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core study IN 11 004 ('core study', a phase III, multicenter, randomized, double-blind, double-dummy, active-controlled Phase 3 study to assess the safety and efficacy of AP CD/LD versus IR CD/LD in fluctuating PD patients).

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Carbidopa Unknown 50 mg
Subject Levodopa Small molecule 400 mg
Subject Levodopa Small molecule 500 mg

Indications