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Cataplexy11/19/2023 ![]() This study shows that many people getting treatment for narcolepsy can switch to LXB without their cataplexy becoming worse. The increase in cataplexy when antidepressants were stopped was smaller in people who switched from SXB to LXB. In those people, cataplexy happened more often at first as they stopped taking antidepressants and then less often later on. Some people were already taking other medicines to treat their cataplexy (such as antidepressants), so they were asked to slowly stop those medicines while taking LXB. In people who only took LXB, cataplexy happened less often over time. This paper is about the first 12 weeks of that study, when all the people taking part in the study first tried LXB to check that they were being given the right amount. A recent study found that treatment with LXB was better at reducing how often people with narcolepsy had sleepiness and cataplexy than no medicine at all (NCT03030599). Lower-sodium oxybate (LXB) is a narcolepsy medicine that is similar to sodium oxybate (SXB) but has 92% less sodium. They may also have sudden muscle weakness (known as cataplexy). People with narcolepsy are often sleepy during the day. ![]() Trial RegistrationĪ Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy identifier: NCT03030599. These results illustrate the feasibility of switching from SXB to LXB while tapering/discontinuing other anticataplectics. LXB monotherapy was effective in reducing cataplexy and increasing cataplexy-free days. During OLOTTP and SDP, TEAEs of worsening cataplexy were reported in 0%, 47.8%, 16.7%, and 2.2% of participants in groups A, B, C, and D, respectively most TEAEs of worsening cataplexy were reported during tapering/discontinuation of other anticataplectics. Median number of cataplexy-free days/week at the end of SDP (study week 14) was similar in all groups (6.0, 6.1, 6.0, and 6.2 in groups A, B, C, and D, respectively). Cataplexy frequency decreased throughout initiation/optimization in anticataplectic-naive participants. Increased cataplexy frequency was observed in participants tapering/discontinuing other anticataplectics during weeks 3–10 and was more prominent in participants taking other anticataplectics alone compared with those taking SXB plus other anticataplectics. Median weekly cataplexy attacks decreased during weeks 1–2 of OLOTTP in all groups. ResultsĪt the beginning of OLOTTP, median weekly cataplexy attacks were lower in participants taking SXB at study entry (SXB only SXB + other anticataplectics ) versus participants who were taking other anticataplectics (3.50) or were anticataplectic naive (5.83). Treatment-emergent adverse events (TEAEs) were recorded throughout the duration of the study. A 2-week stable-dose period (SDP during which participants took a stable dose of open-label LXB) and 2-week double-blind randomized withdrawal period (during which participants were randomized to continue LXB treatment or switch to placebo) followed OLOTTP. Other anticataplectics were tapered/discontinued during weeks 3–10 of OLOTTP. LXB was initiated/optimized during a 12-week, open-label, optimized treatment and titration period (OLOTTP). ![]() ![]() MethodsĮligible participants (adults aged 18–70 years with narcolepsy with cataplexy) entered the study taking SXB only (group A), SXB + other anticataplectics (group B), or anticataplectic medication other than SXB (group C), or were cataplexy-treatment naive (group D). The aim of these analyses was to evaluate cataplexy frequency during initiation/optimization of LXB and taper/discontinuation of prior antidepressant/anticataplectic medications. Additional analyses of data from this study were conducted to explore the effects of LXB on cataplexy, including the clinical course and feasibility of transition from other anticataplectics to LXB monotherapy. LXB was shown to improve cataplexy and excessive daytime sleepiness in people with narcolepsy in a placebo-controlled, double-blind, randomized withdrawal study (NCT03030599). Lower-sodium oxybate (LXB) is an oxybate medication with the same active moiety as sodium oxybate (SXB) and a unique composition of cations, resulting in 92% less sodium. ![]()
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