{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Espay AJ"],"funding":["NCATS NIH HHS","NIMH NIH HHS","NINDS NIH HHS","Amneal Pharmaceuticals"],"pagination":["428-432"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10922967"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["39(2)"],"pubmed_abstract":["<h4>Background</h4>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.<h4>Objectives</h4>To evaluate the safety and efficacy of IPX203 in an open-label extension of the pivotal phase 3 study.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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."],"journal":["Movement disorders : official journal of the Movement Disorder Society"],"pubmed_title":["Safety and Efficacy of IPX203 in Parkinson's Disease: The RISE-PD Open-Label Extension Study."],"pmcid":["PMC10922967"],"funding_grant_id":["R01 NS120560","K23 MH092735","UL1 TR003107"],"pubmed_authors":["Hauser RA","Thakkar S","Espay AJ","Dhall R","Visser H","Banisadr G","Cloud L","Zeitlin L","Fisher S"],"additional_accession":[]},"is_claimable":false,"name":"Safety and Efficacy of IPX203 in Parkinson's Disease: The RISE-PD Open-Label Extension Study.","description":"<h4>Background</h4>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.<h4>Objectives</h4>To evaluate the safety and efficacy of IPX203 in an open-label extension of the pivotal phase 3 study.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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.","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Feb","modification":"2026-06-01T18:11:44.866Z","creation":"2025-04-05T19:19:48.915Z"},"accession":"S-EPMC10922967","cross_references":{"pubmed":["38111267"],"doi":["10.1002/mds.29685"]}}