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Methods: The Safety and Efficacy of Tasimelteon (SET) study is a multicenter, double-masked, placebo-controlled investigation of tasimelteon to treat Non-24 in totally blind patients. Circadian period was assessed from urinary excretion of urinary 6-sulfatoxymelatonin (aMT6s) and cortisol. Patients with sleep complaints and a confirmed non-24-hour circadian period were enrolled. Patients received tasimelteon (20mg) or placebo daily for 6 months at a fixed clock time one hour before their preferred bedtime. Circadian period was reassessed beginning 2 weeks after initiating treatment. Subjective nighttime sleep and daytime naps were reported daily.
Results: 84 patients (34F, age 21-84 yrs) were randomized and 79 were assessed for entrainment. The proportion of patients entrained by tasimelteon was greater compared to placebo as measured by urinary aMT6s and cortisol timing (p=0.0171 and p=0.0313, respectively). The number of clinical responders [defined as entrained plus a score ≥3 on the Non-24 Clinical Response Scale (N24CRS)] was greater for tasimelteon, and there was also significant improvement in Clinical Global Impression of Change, and measures of total night-time sleep, daytime nap duration, and mid-point of sleep timing (MoST) as compared to placebo (p<0.05). Tasimelteon was safe and well-tolerated.
Conclusion: Tasimelteon entrained circadian rhythms as measured by melatonin and cortisol in blind patients with Non-24. Tasimelteon-treated patients also showed significant clinical improvement in multiple sleep and wake measures and in overall global functioning. This study demonstrates that tasimelteon is an effective circadian regulator that is able to entrain the circadian pacemaker, and these results provide evidence of a direct and clinically meaningful benefit to patients with Non-24.
Disclosure: SWL: Investigator, Vanda Pharmaceuticals Inc. . MAD: Employee, Vanda Pharmaceuticals Inc. . CX: Employee, Vanda Pharmaceuticals Inc. . DMF: Consultant, Vanda Pharmaceuticals Inc. . RT: Employee, Vanda Pharmaceuticals Inc. . CL: Employee, Vanda Pharmaceuticals Inc. . LL: Employee, Vanda Pharmaceuticals Inc. . MHP: , Vanda Pharmaceuticals Inc. .
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