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BOOST-PD: Crexont in Parkinson's Disease
NCT07138560Phase 4
Key facts
- Status
- Recruiting
- Start
- Jul 2025
- Primary completion
- Feb 2027
- Countries
- 1
- Sponsor
- Cleveland Clinic
- Modality
- Small Molecules
- Drugs
- levodopa
- Conditions
- Parkinson's disease (PD)
01
Overview
Phase 4, open-label, single-arm trial of levodopa in Parkinson's disease (PD), sponsored by Cleveland Clinic. Primary endpoint: Change in the duration and quality of good on-time at 8 weeks. Started Jul 2025; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Intervention Arm
Patients converting to shorter dose intervals of Crexont (IPX203)
03
Who it enrols
Patients 40 years or older with idiopathic Parkinson's disease, levodopa responsive, baseline MDS-UPDRS OFF-state > 20, on a stable regimen of CD-LD for at least 4 weeks, experiencing >= 2 hours of off time per day. Excludes severe dyskinesia, device-aided therapies, and significant levodopa-related complications.
04
Endpoints
Primary
Change in the duration and quality of good on-time
Secondary
Changes in the tremor scores
Difference between starting and final IPX203 doses
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