Sleep disturbance is often associated with RLS. In this clinical trial, patients completed the Medical Outcomes Study (MOS) Sleep Scale to assess the impact of XP13512 treatment on sleep. At Week 12, XP13512-treated patients, compared to placebo-treated patients, had statistically significant improvements in sleep quantity and sleep adequacy, as well as statistically significant reductions in sleep disturbance and daytime somnolence.
The PIVOT RLS I clinical trial used a 24-hour diary to collect the presence and severity of RLS symptoms every 30 minutes starting at 8:00 a.m. At the end of the study, more than half of patients treated with XP13512 were symptom-free for the 24-hour assessment period compared to 18 percent of placebo-treated patients.
The two most commonly reported adverse events in the study were somnolence (27 percent, XP13512 vs. 7 percent, placebo) and dizziness (20 percent, XP13512 vs. 5 percent, placebo), with the majority reported as mild-to- moderate in intensity. Nine patients (8 percent) who received XP13512 withdrew from study participation due to adverse events compared to three patients (3 percent) who received placebo. No clinically meaningful changes in vital signs or laboratory parameters were observed.
In addition, the Epworth Sleepiness Scale (ESS), a reliable tool
designed to measure daytime drowsiness, was used to evaluate the likelihood
of patients dozing or falling asleep in common situations of daily living,
such as sitting and reading or watching TV. At Week 12, the ESS scores for
patients in the XP13512 group were lower than patients in the placebo
group, indicating that XP13512 treatment was associated with less daytime
drowsiness. The findings on the ESS scale are consistent with the reduction
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