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Clinical Data With Foscarbidopa/Foslevodopa CSCI in Parkinson Disease
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Panelists discuss how phase 3 clinical trials demonstrated the efficacy, safety, and quality of life improvements associated with continuous subcutaneous foscarbidopa/foslevodopa in both short-term and long-term studies.
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Summary of Phase 3 Clinical Trials for Continuous Subcutaneous Foscarbidopa/Foslevodopa
12-Week Randomized, Double-Blind Trial
Efficacy
- Significant reduction in OFF time compared to placebo (primary end point)
- Meaningful increase in ON time without troublesome dyskinesia
- Improved UPDRS motor scores during ON periods
- Greater proportion of patients achieved ≥1 hour reduction in daily OFF time
- Effects observed as early as week 1 and maintained throughout the trial
Safety
- Most common adverse events: infusion site reactions, nausea, dyskinesia
- Majority of infusion site reactions were mild to moderate in severity
- Low discontinuation rate due to adverse events (~5%)
- No clinically significant changes in laboratory values
- No unexpected safety signals compared to oral levodopa/carbidopa
- No serious device-related complications
Quality of Life
- Significant improvement in PDQ-39 scores (Parkinson’s Disease Questionnaire)
- Enhanced patient-reported daily functioning
- Improved sleep quality measures
- Reduced caregiver burden
- High treatment satisfaction scores
52-Week Open-Label Extension Trial
Efficacy
- Sustained reduction in OFF time throughout the extended treatment period
- Maintained improvement in ON time without troublesome dyskinesia
- Stable UPDRS motor scores, suggesting durable symptomatic control
- Reduced need for rescue medication compared to baseline
- No evidence of tolerance development
Safety
- Consistent safety profile with the 12-week study
- Declining incidence of infusion site reactions over time, suggesting adaptation
- No new safety concerns with prolonged exposure
- Manageable and predictable adverse event profile
- Low rate of serious adverse events related to treatment
- Device-related complications remained infrequent
Quality of Life
- Sustained improvement in PDQ-39 scores through 52 weeks
- Maintained positive impact on activities of daily living
- Persistent improvement in sleep quality
- Stable or improved non-motor symptom scores
- High retention rate, indicating acceptable patient tolerability and satisfaction
Clinical Implications
- Continuous subcutaneous foscarbidopa/foslevodopa provides a viable alternative for advanced Parkinson disease patients with motor fluctuations
- The prodrug formulation allows for stable plasma levodopa levels, potentially addressing the limitations of oral therapy
- Benefits appear durable over the long-term with a manageable safety profile
- May be particularly beneficial for patients with refractory motor fluctuations or those unsuitable for deep brain stimulation
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