NCT07138560 BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease
| NCT ID | NCT07138560 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The Cleveland Clinic |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2025-07-24 |
| Primary Completion | 2027-02-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 22 participants in total. It began in 2025-07-24 with a primary completion date of 2027-02-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * \- Participant is 40 years or older * Diagnosed with idiopathic Parkinson's disease and is deemed to be levodopa responsive * Baseline MDS-UPDRS score in OFF-state is \> 20 * Patient is being treated with a stable regimen of CD-LD for at least four weeks * The minimum most frequent levodopa dosing is 100 mg if using IR CD-LD and 195mg if using Rytary; maximum levodopa dosing per day is 1200 mg if using IR CD-LD, 1000 mg if associated with a COMT inhibitor, and 2400 mg if using Rytary * Participant can be on stable doses of any levodopa adjunctive medications and/or psychotropic medications for at least 30 days * Participant experiences off time estimated at 2 hours or more per day; participant can comply with the wearable kinematic device. Exclusion Criteria: * \- Participants with severe dyskinesia as defined by a score of 4 on Question 4.1 (time spent with dyskinesia) of UPDRS IV * Currently on device-aided therapies for advanced PD * Using controlled-release CD-LD apart from a single daily bedtime dose * Using "on demand" therapy unless willing to stop it during the study period * Have a diagnosis hypothesis of dopamine dysregulation syndrome or evidence of significant levodopa-related complications including orthostatic hypotension or psychosis * History of dementia or MOCA score lower than 23 * Significant medical history might interfere significantly with study participation * Being enrolled in other clinical trials involving active medication interventions.
Contact & Investigator
Hubert Fernandez, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT07138560 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07138560 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07138560 currently recruiting?
Yes, NCT07138560 is actively recruiting participants. Contact the research team at ANISS2@ccf.org for enrollment information.
Where is the NCT07138560 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07138560 clinical trial?
NCT07138560 is sponsored by The Cleveland Clinic. The principal investigator is Hubert Fernandez, MD at The Cleveland Clinic. The trial plans to enroll 22 participants.
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