Last updated on August 2018

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


Brief description of study

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).

Detailed Study Description

This will be a multi-center, global, open-label study in adult suffering from fluctuating Parkinson's disease subjects who have successfully completed the core study IN 11 004.

After signing informed consent and meeting inclusion/exclusion criteria, eligible subjects will be enrolled into a 12-month open-label extension and receive the AP-CD/LD as needed.

Efficacy and safety will be assessed throughout the study period.

Clinical Study Identifier: NCT02615873

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Janusz Kapustecki, MD

Anna Kapustecka Prywatna Przychodnia Specjalistyczna STOMED
Czestochowa, Poland
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