Concomitant Medication Use in Progressive Supranuclear Palsy Clinical Trial Participants

Progressive Supranuclear Palsy (PSP) is a rare and progressive movement disorder pathologically characterized by tau tangles for which there are no effective therapies. Emerging therapies for Alzheimer’s Disease are increasingly focus on tau and consequently, PSP has emerged as an attractive patient population in which to test novel tau-directed therapies. There are currently no approved therapies for PSP; however, most PSP patients are treated with multiple medications to address some of the symptoms of PSP and comorbidities found in this patient population. The risks of polypharmacy to patient safety as well as clinical trial outcome measures are clearly evident. Data on medication use extracted from an interventional study in subjects with PSP revealed that PSP patients were on an average (SD) of 8.5 (4.7) medications at the time of enrollment in to the study. Dopaminergic agents and antidepressants were the two most common classes of medications used by 53% and 46% of subjects respectively. Approximately a third of subjects enrolling in this study were on a potentially inappropriate medication. A substantial number of subjects were on combinations of medications known to be associated with adverse reactions due to drug-drug interactions. Given their particular susceptibility to the consequences of polypharmacy, clinicians and pharmacists need to be aware and cautious about the treatment of PSP patients. Additionally, it is important to recognize these concomitant medications when formulating the inclusion-exclusion criteria for clinical trials.