Category: Parkinson’s Disease: Clinical Trials
Objective: Evaluate interim outcomes from the real-world study of IPX203, assessing its impact to extend “Good On” time and reduce “Off” time in PD patients after switching from other levodopa-based therapies.
Background: IPX203, an extended-release carbidopa-levodopa formulation containing a mucoadhesive polymer, is designed to improve levodopa delivery and absorption.
Method: ELEVATE-PD is an ongoing, open-label phase 4 study where PD patients are converted from IR CD/LD, IR + COMT inhibitors, or IPX066 to IPX203. Following a 5-week dose-optimization period and a 1-week stable dosing, patients are followed for 12 months. Eligible participants had ≥ 2.5 hours of daily “Off” time at baseline. The primary endpoint is change in daily “Good On” time from baseline/Visit 1 to Day 42/Visit 4. This interim analysis includes 111 patients who completed Day 42.
Results: At baseline, mean daily “Good On” time was 9.39 ± 2.53 hours, “Off” time was 6.21 ± 2.31 hours:
– IPX203 treatment increased daily “Good On” time: +3.40 hours for patients switching from IR CD/LD (n=74), +2.91 hours from IR + COMT inhibitors (n=9), +3.07 hours from IPX066 (n=22).
– Corresponding reductions in “Off” time were: -3.18, -3.09, -2.90 hours, respectively.
– IPX203 increased “Good On” time per dose by: +2.09, +0.91, +0.98 hours, respectively.
– IPX203 also improved MDS-UPDRS total scores: -15.3, -10.0, -10.3 points, respectively.
– Majority of TEAEs were mild-to-moderate; most common (≥3%) were dizziness (9.0%), nausea (7.2%), fall (7.2%), dyskinesia (4.5%), hallucination (3.6%), headache (3.6%).
Conclusion: Switching from other levodopa-based therapies to IPX203 significantly improved daily symptom control by increasing “Good On” time, decreasing “Off” time, and enhancing motor function across all treatment groups.
To cite this abstract in AMA style:
R. Hauser, S. Isaacson, S. Betté, A. Richmond, M. Jay, G. Banisadr, S. Fisher, H. Visser. Improved “Good On” Time and Reduced Motor Fluctuations After Switching to IPX203: Interim Real-World Results from the First 111 Patients in ELEVATE PD [abstract]. Mov Disord. 2026; 41 (suppl 1). https://www.mdsabstracts.org/abstract/improved-good-on-time-and-reduced-motor-fluctuations-after-switching-to-ipx203-interim-real-world-results-from-the-first-111-patients-in-elevate-pd/. Accessed October 1, 2026.« Back to 2026 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/improved-good-on-time-and-reduced-motor-fluctuations-after-switching-to-ipx203-interim-real-world-results-from-the-first-111-patients-in-elevate-pd/