Foslevodopa/Foscarbidopa Reduces Troublesome Dyskinesia in People with Advanced Parkinson’s Disease in Two Phase Three Clinical Trials
Robert Hauser1, Angelo Antonini2, Daniel Garbin Di Luca3, Eric Freire Alvarez4, Michelle Oliveira Fernandes5, Megha Shah5, Lars Bergmann5, Resmi Gupta5, Marie O'Meara5, David Standaert6
1University of South Florida Parkinson’s Disease and Movement Disorders Center of Excellence, 2Parkinson and Movement Disorders Unit, Center for Neurodegenerative Diseases CESNE, Department of Neuroscience, University of Padova, 3Department of Neurology, Washington University in St. Louis, 4Department of Neurology, Movement Disorders Unit, Hospital General Universitario of Elche, 5AbbVie Inc., 6Center for Neurodegeneration and Experimental Therapeutics, University of Alabama at Birmingham
Objective:
To evaluate reductions of troublesome dyskinesia (TSD) in people with advanced Parkinson’s disease (aPD) following treatment with foslevodopa/foscarbidopa (LDp/CDp) in two phase 3 clinical trials.
Background:
Dyskinesias are involuntary movements that can be painful and impact functioning and daily activities. In phase 3 studies, treatment with LDp/CDp resulted in increased “good On” time (“On” with no dyskinesia or with non-TSD).
Design/Methods:
This post hoc analysis included data from people with aPD treated with LDp/CDp in a 12-week, phase 3, double-blind, randomized controlled trial (RCT; NCT04380142) or a 52-week, phase 3, single-arm, open-label trial (OLT; NCT03781167). Eligible participants were aged ≥30 years and had ≥2.5 hours “Off” time per day. The PD diary was used to measure Time spent “Off” and “On” (with or without dyskinesia). Final visit values represent the last nonmissing postbaseline assessment.
Results:
More than one-third of participants experienced any TSD at baseline (RCT, 27/74 [36.5%]; OLT, 99/244 [40.6%]). Among participants with ≥1 hour of TSD at baseline (RCT, 22/74 [29.7%]; OLT, 83/244 [34.0%]), between one-third and one-half (RCT, 8/22 [36.4%]; OLT, 48/83 [57.8%]) had no TSD at their final visit. Of participants with >1 hour of TSD at baseline (RCT, 12/74 [16.2%]; OLT, 66/244 [27.0%]), one-third to over one-half (RCT, 4/12 [33.3%]; OLT, 40/66 [60.6%]) had no TSD at the final visit.
Conclusions:
Many participants with aPD no longer had TSD following treatment with LDp/CDp, regardless of the duration of their TSD at baseline.
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