Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Feb;39(2):428-432.
doi: 10.1002/mds.29685. Epub 2023 Dec 18.

Safety and Efficacy of IPX203 in Parkinson's Disease: The RISE-PD Open-Label Extension Study

Affiliations
Randomized Controlled Trial

Safety and Efficacy of IPX203 in Parkinson's Disease: The RISE-PD Open-Label Extension Study

Alberto J Espay et al. Mov Disord. 2024 Feb.

Abstract

Background: IPX203 is a novel oral extended-release formulation of carbidopa/levodopa (CD/LD) developed to address the short half-life of immediate-release CD/LD. In the phase 3 RISE-PD trial, IPX203 significantly improved "Good On" time in patients with Parkinson's disease compared with immediate-release CD/LD.

Objectives: To evaluate the safety and efficacy of IPX203 in an open-label extension of the pivotal phase 3 study.

Methods: This 9-month extension enrolled patients who completed the randomized, double-blind trial. Key efficacy endpoints included Movement Disorder Society-Unified Parkinson's Disease Rating Scale and Patient and Clinical Global Impression scores. Adverse events (AEs) were recorded.

Results: Improvements in efficacy were maintained and dosing frequency and total daily dose remained stable through the trial. A total of 52.7% of patients experienced ≥1 treatment-emergent AE, mostly mild or moderate and occurred within the first 90 days of treatment.

Conclusions: In this phase 3 open-label extension, IPX203 exhibited a favorable safety and tolerability profile and sustained efficacy of comparable magnitude to the end of the double-blind study. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Keywords: extended release; levodopa; motor fluctuations; parkinson's diseases.

PubMed Disclaimer

Conflict of interest statement

Financial Disclosure/Conflict of Interest:

Alberto J. Espay is a study investigator for, has received honoraria and travel support from, and serves as a consultant and on the Speakers’ Bureau for Amneal.

Robert A. Hauser is a study investigator for, has received honoraria and travel support from, and serves as a consultant and on the Speakers’ Bureau for Amneal.

Rohit Dhall is a study investigator for Amneal.

Sandeep Thakkar is a study investigator for and has received honoraria and travel support from Amneal.

Leslie Cloud is a study investigator for Amneal.

Leonid Zeitlin is a consultant for Quartesian, LLC, a company that provides clinical data services to Amneal.

Ghazal Banisadr, Stanley Fisher, and Hester Visser are employees of Amneal and may hold stock or ownership interest in Amneal.

References

    1. LeWitt PA. Levodopa therapy for Parkinson’s disease: pharmacokinetics and pharmacodynamics. Mov Disord 2015; 30(1): 64–72. - PubMed
    1. Stocchi F The levodopa wearing-off phenomenon in Parkinson’s disease: pharmacokinetic considerations. Expert Opin Pharmacother 2006; 7(10): 1399–1407. - PubMed
    1. Hauser RA, Espay AJ, LeWitt P, et al. IPX203 vs Immediate-Release Carbidopa-Levodopa for the Treatment of Motor Fluctuations in Parkinson Disease The RISE-PD Randomized Clinical Trial. JAMA Neurol 2023; doi:10.1001/jamaneurol.2023.2679. - DOI - PMC - PubMed
    1. Goetz CG, Tilley BC, Shaftman SR, et al. Movement Disorder Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord 2008; 23(15): 2129–2170. - PubMed
    1. Margolesky J, Singer C. Extended-release oral capsule of carbidopa-levodopa in Parkinson disease. Ther Adv Neurol Disord 2018; 11: 1756285617737728. - PMC - PubMed

Publication types