Improvement seen in measures of sleepiness, cataplexy over eight weeks versus placebo, but drug was associated with hepatotoxic effects<\/p>\n<\/h3>\n
By Elana Gotkine HealthDay Reporter<\/b><\/p>\n
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THURSDAY, July 27, 2023 (HealthDay News) — For patients with narcolepsy type 1, an orexin receptor 2 agonist, TAK-994, improves measures of sleepiness and cataplexy over eight weeks compared with placebo but is associated with hepatotoxic adverse events, according to a study published in the July 27 issue of the New England Journal of Medicine<\/em>.<\/p>\n Yves Dauvilliers, M.D., from Gui de Chauliac Hospital and the University of Montpellier in France, and colleagues conducted a phase 2 randomized, placebo-controlled trial of TAK-994 in patients with narcolepsy type 1. Seventy-three patients were randomly assigned to receive twice-daily oral TAK-994 (30 mg [17 patients], 90 mg [20 patients], and 180 mg [19 patients]) or placebo (17 patients).<\/p>\n Owing to hepatotoxic adverse events, the phase 2 trial and extension trial were terminated early. Primary end point data were available for 41 patients. The researchers found that the least-squares mean changes to week 8 in average sleep latency on the Maintenance of Wakefulness Test were 23.9, 27.4, 32.6, and \u00e2\u0088\u00922.5 minutes in the 30-, 90-, and 180-mg groups and placebo group, respectively. The corresponding least-squares mean changes to week 8 in the Epworth Sleepiness Scale were \u00e2\u0088\u009212.2, \u00e2\u0088\u009213.5, \u00e2\u0088\u009215.1, and \u00e2\u0088\u00922.1, respectively. The corresponding weekly incidences of cataplexy at week 8 were 0.27, 1.14, 0.88, and 5.83 (rate ratios versus placebo, 0.05, 0.20, and 0.015, respectively).<\/p>\n “The outcomes described in the current report may be seen as a backward step because of the decision to terminate the trial,” write the authors of an accompanying editorial. “However, the impressive efficacy is a major step forward in helping patients with narcolepsy type 1.”<\/p>\n The study was funded by Takeda Development Center Americas.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n Editorial (subscription or payment may be required)<\/a><\/p>\n <\/i><\/p>\n