Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 4322795 | Other Grant/Funding Number | Amneal Pharmaceuticals LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Amneal Pharmaceuticals, LLC | INDUSTRY |
Not provided
Not provided
Not provided
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.
This research is being done because a new, longer-duration formulation of levodopa named IPX203 (brand name: Crexont®) has been recently approved by the FDA. The pivotal study on this drug demonstrated that IPX203 significantly increased the daily good on-time compared to immediate release carbidopa-levodopa (IR CD-LD), where good on-time is the time when the Parkinson's symptoms are improved without troublesome dyskinesias. In that study, the participants were taking IPX203 a mean of 3 times per day which still left a mean of 4.18 hours of off-time per day (when symptoms returned). These data were based on diaries filled out by the participants.
The aim of the study is to expand the current knowledge on IPX203, analyzing the changes in good on-time after careful and tailored adjustments, as in the real-world setting. This will be done with the assistance of a wearable device to obtain objective data. Additional variables such as changes in the tremor scores, conversion from other drugs such as Rytary and COMT inhibitors, and the difference between starting and final IPX203 doses will be evaluated.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Other | The intervention arm will be patients converting to shorter dose intervals of Crexont (IPX203) and allowing for higher dosing frequency, as practiced in real-world settings, combined with objective monitoring of on-time periods and other parameters using the KinesiaU device, could reveal additional benefits of Crexont (IPX203) treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CREXONT ER | Drug | exploring shorter dose intervals of Crexont (IPX203) and allowing for higher dosing frequency, as practiced in real-world settings, combined with objective monitoring of on-time periods |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | Mean change in the average duration of good on-time from baseline to end of study | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint | Mean change in the average 'slowness' scores as measured by KinesiaU | 8 weeks |
| Secondary Endpoint | Mean change in time spent with tremor as measured by KinesiaU |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Endpoints | Mean difference between KinesiaU and PD diary measurements of change in good on-time from baseline to end of study | 8 weeks |
| Exploratory Endpoint | Difference in the Patient Global Impression of Change from baseline to end of study. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saar Anis, MD | Contact | 216 678-8896 | ANISS2@ccf.org | |
| Mary Carmell Beukemann | Contact | 216-372-2867 | beukemm@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Hubert Fernandez, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31306216 | 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. | |
| 37578800 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 8 weeks |
| Secondary Endpoint | Mean change in the average tremor scores as measured by KinesiaU | 8 weeks |
| Secondary Endpoint | Mean change in time spent with dyskinesia as measured by KinesiaU | 8 weeks |
| Secondary Endpoint | Mean change in the continuous on time as measured by KinesiaU | 8 weeks |
| 8 weeks |
| Exploratory Endpoint | Difference between Non-Motor Fluctuation Assessment Questionnaire from baseline to end of study. | 8 weeks |
| Exploratory Endpoint | The average time (in weeks) taken to reach the final dose. | 8 weeks |
| Exploratory Endpoint | The average number of adjustments needed to reach the final dose. | 8 weeks |
| 39733558 | 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |