Actively Recruiting
BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease
Led by The Cleveland Clinic · Updated on 2025-08-24
22
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
A
Amneal Pharmaceuticals, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is 40 years or older
- Diagnosed with idiopathic Parkinson's disease and responsive to levodopa
- Baseline MDS-UPDRS score in OFF-state is greater than 20
- Treated with stable carbidopa-levodopa regimen for at least four weeks
- Minimum levodopa dosing: 100 mg daily if using IR CD-LD, 195 mg if using Rytary; maximum dosing limits vary by medication
- Stable doses of levodopa adjunctive or psychotropic medications for at least 30 days
- Experiences off time of 2 hours or more daily
- Able to comply with wearable kinematic device use
You will not qualify if you...
- Severe dyskinesia with a score of 4 on UPDRS IV Question 4.1
- Currently receiving device-aided therapies for advanced Parkinson's disease
- Using controlled-release carbidopa-levodopa except a single bedtime dose
- Using on-demand therapy unwilling to stop during the study
- Diagnosis or suspicion of dopamine dysregulation syndrome or significant levodopa-related complications
- History of dementia or MOCA score below 23
- Significant medical history interfering with study participation
- Enrolled in other clinical trials with active medication interventions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
S
Saar Anis, MD
CONTACT
M
Mary Carmell Beukemann
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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