Safety and Tolerability of Serial Cerebrospinal Fluid (CSF) Collections During Pharmacokinetic/Pharmacodynamic Studies: 5 Years Experience

Abstract

Purpose.To characterize the patient population, and evaluate safety and tolerability of serial CSF collections. Methods:A comprehensive chart review of subjects who underwent sequential sampling of CSF pooled from six studies that employed serial CSF sampling. Extracted information included subject demographic characteristics (age, sex, disease), adverse events (AE) severity, and actions taken as a result of the AE. Results.Seventy-eight subjects were evaluated; age range 25–89; mean 64 years and median of 67 years. The majority of the subjects was male (71%) with a diagnosis of probable Alzheimer's disease (81%). All AEs were of mild or moderate in severity. Headache (HA) was the most commonly reported AE, reported by 35/78 (45%). HA was usually ameliorated by bedrest and fluids; analgesics were administered to 12 subjects with headaches. Back pain/stiffness was reported in 19/78 (24%) subjects, acetaminophen was administered to 2 subjects. Neck/shoulder pain was reported by 8/78 (10%), one subjects received acetaminophen for the pain. There were 12/78 (10%) of subjects reporting pain at lumbar puncture site. A vaso-vagal reaction occurred in 3/78 (4%), 2 required administration of IV fluids. The incidence was resolved successfully within a couple of hours. No subjects had an infection, required a blood patch or withdrew from the study as a result of CSF collection. Conclusion.The procedure employed during serial CSF collection proved to be safe and tolerable, causing minimal discomfort to the subjects.