HealthDay News — For patients with Parkinson’s disease (PD) and excessive daytime sleepiness (EDS), sodium oxybate seems effective and well-tolerated, according to a study published online in JAMA Neurology.
Fabian Büchele, MD, from University Hospital Zurich in Switzerland, and colleagues conducted a randomized trial involving 12 patients with PD and EDS. Patients were randomized to a treatment sequence (sodium oxybate followed by placebo or placebo followed by sodium oxybate); 11 patients completed the study.
The researchers found that sodium oxybate improved EDS as measured objectively (mean sleep latency, +2.9 minutes) and subjectively (Epworth Sleepiness Scale score, −4.2 points) among the 12 patients in the intention-to-treat population.
Eight patients exhibited a positive treatment response defined electrophysiologically. Significant improvement in subjective sleep quality and objectively measured slow-wave sleep duration (+72.7 minutes) were seen with sodium oxybate. In the per-protocol analysis, the differences were more pronounced. Sodium oxybate was generally well-tolerated, but it induced de novo obstructive sleep apnea in 2 patients and parasomnia in one patient; these patients did not benefit from treatment.
“Special monitoring with follow-up polysomnography is necessary to rule out treatment-related complications and larger follow-up trials with longer treatment durations are warranted for validation,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including UCB Pharma, which partially funded the study.
Büchele F, Hackius M, Schreglmann SR, et al. Sodium oxybate for excessive daytime sleepiness and sleep disturbance in Parkinson’s disease: a randomized clinical trial [published online November 6, 2017]. JAMA Neurol. doi:10.1001/jamaneurol.2017.3171