drugset / Trial / NCT07138560
BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the effect of IPX203 (Crexont®) - the newest extended-release levodopa formulation - on the duration and quality of good on time, using a wearable device to monitor symptoms. 'Good on time' refers to a period (minutes to hours) when a patient experiences optimal symptom control due to effective medication and has better overall functioning without troublesome dyskinesias. The change in the duration and quality of on-time will be measured by a wearable device placed on your wrist called KinesiaU.
Timeline
- Start
- 2025-07-24
- Primary completion
- 2026-12-15
- Completion
- 2027-05-15
Publications
- Background Modi NB, Mittur A, Dinh P, Rubens R, Gupta S. Pharmacodynamics, Efficacy, and Safety of IPX203 in Parkinson Disease Patients With Motor Fluctuations. Clin Neuropharmacol. 2019 Sep/Oct;42(5):149-156. doi: 10.1097/WNF.0000000000000354.
- Background Hauser RA, Espay AJ, Ellenbogen AL, Fernandez HH, Isaacson SH, LeWitt PA, Ondo WG, Pahwa R, Schwarz J, Stocchi F, Zeitlin L, Banisadr G, Fisher S, Visser H, D'Souza R. IPX203 vs Immediate-Release Carbidopa-Levodopa for the Treatment of Motor Fluctuations in Parkinson Disease: The RISE-PD Randomized Clinical Trial. JAMA Neurol. 2023 Oct 1;80(10):1062-1069. doi: 10.1001/jamaneurol.2023.2679.
- Background Hauser RA, Fernandez HH, Jimenez-Shahed J, Allard S, Banisadr G, Fisher S, D'Souza R. Duration of "Good On" time per dose: Immediate-release carbidopa-levodopa vs. extended-release carbidopa-levodopa (IPX203, CREXONT(R)). Parkinsonism Relat Disord. 2025 Feb;131:107239. doi: 10.1016/j.parkreldis.2024.107239. Epub 2024 Dec 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crexont | Unknown | — | — |