AAN 2023: Poorly controlled disease’s long-term burden evaluated
PROSPECT clinical trial will assess how patients' 'off' episodes vary over time with advanced Parkinson's
Abbvie is funding a clinical trial called PROSPECT to assess how clinical outcomes and disease burden change over time for people with Parkinson’s disease whose symptoms are not adequately controlled with available treatments.
Interim data from the trial, presented at this year’s American Academy of Neurology (AAN) annual meeting, suggest the amount of time patients spent with uncontrolled symptoms didn’t change much over the year. The poster was titled, “Evaluation of the Clinical Outcomes and Disease Burden in Advanced Parkinson’s Disease Patients: PROSPECT Study Preliminary Results.”
Treatments such as levodopa can be effective for easing some symptoms of Parkinson’s disease. However, even with available therapies, many people with advanced disease have “off” episodes where their symptoms aren’t adequately controlled between doses.
PROSPECT — short for prospective observational study to evaluate the disease progression and burden of disease in patients with Parkinson’s disease inadequately controlled by conventional therapy — will assess how off episodes vary over time with advanced Parkinson’s. The study will also evaluate changes in nonmotor symptoms, changes in quality of life, in utilizing health resources, and in impairments in work productivity and activity.
The presented data referred to 90 patients from the U.S., Japan, Spain, and Australia. The average patient age at the start of the study was nearly 69, just over half were male, and most were either white (55.6%) or Asian (42.2%). Most were being treated with levodopa and/or other Parkinson’s therapies, but all were still seeing at least 2.5 hours of off time a day, with an average of five hours off time a day.
Interim data were available for 76 patients followed for at least six months and 61 followed for at least a year. Results showed the average daily off time decreased slightly — by about six minutes at six months and 30 minutes at a year — but the change wasn’t statistically significant compared to the values at the start of the study and there was a lot of variation from patient to patient.
“While there is a slight change in ‘off’ time after [one year], this change was not statistically significant,” the researchers said, noting the finding illustrates that the symptoms are still not being adequately controlled after a year.
The PROSPECT study is ongoing and the researchers hope its results will provide real-world insights on the progression and disease burden for people with advanced, poorly controlled Parkinson’s.
Note: The Parkinson’s News Today team is providing coverage of the American Academy of Neurology (AAN) 2023 Annual Meeting April 22-27. Go here to see the latest stories from the conference.