Numerous studies demonstrate that continuous levodopa infusion can result in reductions of more than 50 percent in time spent in the "off" state and time spent with severe dyskinesias. However, to date, such therapies have been difficult or impractical. DopaFuse is a therapy to safely and continuously infuse a levodopa prodrug subcutaneously. DopaFuse contains a daily dose of levodopa in a volume of 3 mL. Upon subcutaneous infusion, the prodrug is rapidly converted into levodopa, providing stable plasma levodopa concentrations.
This Phase II clinical study of DopaFuse in Parkinson’s disease (PD) patients with motor fluctuations. Its primary objectives are: i) to assess the safety and tolerability of continuous subcutaneous infusion of DopaFuse, and ii) to determine the pharmacokinetics of subcutaneous infusion of DopaFuse as compared to oral levodopa administration. Secondary objectives are: i) to determine the conversion factor with which subjects can be switched from oral levodopa to DopaFuse, and ii) to determine preliminary efficacy.
Relevance to Diagnosis/Treatment of Parkinson’s Disease:
Today, PD patients whose motor fluctuations are poorly controlled with oral medications have limited treatment options. If successful, DopaFuse would provide a safe, convenient treatment alternative that would dramatically reduce motor fluctuations.
Previous studies have demonstrated that stabilization of patients’ plasma levodopa concentrations results in major reductions in motor fluctuations. The primary goals of this study are to demonstrate that DopaFuse administration is well tolerated at the infusion site and that subcutaneous delivery of DopaFuse results in stabilized plasma levodopa concentrations. Positive results from the study will validate the feasibility of subcutaneous DopaFuse administration, enabling continued clinical development of DopaFuse.
This grant was selected by The Michael J. Fox Foundation staff to be highlighted via the Foundation’s Partnering Program.
Based on data from pre-clinical models, the route of administration and formulation have been modified to enable better tolerability. The originally planned clinical trial has been redesigned.