during the 12-month study. [10]
10/09/2012 17:06:15
Jun 12: Results from two (n=1,021 and 1,009) pivotal PIII RCTs reported. Patients with primary insomnia were randomized to high dose suvorexant (40mg for 18-64 year olds or 30mg for ≥65 year olds), low dose suvorexant (20mg or 15mg based on age), or to placebo, for 3 months. In both trials, patients on suvorexant fell asleep faster and stayed asleep longer vs placebo at months 1 and 3 (p<0.003) (patient-reported primary outcomes). Specifically, in trial 1 at 3 months, suvorexant reduced the time to fall asleep by 25.7 minutes (vs. 17.3 minutes with placebo) and sleep lasted 60.3 minutes longer (vs. 40.6 minutes) compared to baseline. On objective primary outcomes (polysomnographic, sleep lab-based), in both trials suvorexant reduced the time it took patients to fall into continuous sleep at month 1 and decreased the time patients spent awake during the night at 1 and 3 months. In trial 1, patients on suvorexant entered into continuous sleep 36 minutes faster (vs. 26.6 minutes with placebo) and spent less time awake during the night by 47.9 minutes (vs. 25.0 minutes) compared to baseline. The most common AEs with high dose of suvorexant vs placebo were sleepiness (10.7% vs. 3.4% in Trial 1) and headache (6.8 vs. 6%). In the overall study population, there were no statistically significant next day objective residual effects vs placebo as measured by the Digit Symbol Substitution Test [9].
13/06/2012 21:35:23
July 11: Long-term PIII trial (NCT01021813) completed. The randomised, double-blind, placebo-controlled trial investigated the efficacy, safety and tolerability of suvorexant administered for up to 14 months in patients with primary insomnia. The trial enrolled 782 patients in the US. [8]
20/04/2012 15:26:03
June 10: PIIb trial results. 254 patients were randomised to MK 4305 at 10 mg (n=62), 20 mg (n=61), 40 mg (n=59) or 80 mg (n=61) and 249 randomised to placebo. MK4305 was significantly more effective than placebo in improving overall sleep efficiency at night one and at end of wk 4. All doses of MK 4305 improved objectively measured sleep maintenance, as evidenced by significant reductions in the secondary endpoint of baseline-adjusted wake-after-sleep-onset vs. placebo both at night one and at the end of week four. MK 4305 significantly improved objectively-measured sleep onset (80mg dose). Data was presented at the SLEEP 2010 24th Annual Meeting of the Associated Professional Sleep Societies. (4)
11/06/2010 08:52:28
Apr 10: A PIII, multicentre, randomized, double-blind, placebo-controlled, parallel group study (NCT01097629, Study B) is due to start May 10 and is expected to complete Jun 12. The study will investigate the efficacy and safety of MK4305 in high (40mg if <65 years old and 30mg if >65) and low dose (20 and 15mg, respectively) in 945 patients with primary insomnia. The primary co-endpoints are subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep at 1 and 3 months [3].
06/04/2010 09:08:33
Apr 10: A PIII, multicentre, randomized, double-blind, placebo-controlled, parallel group study (NCT01097616, Study A) is due to start May 10 and expected to complete Sep 12. The study will investigate the efficacy and safety of MK4305 in high (40mg if <65 years old and 30mg if >65) and low dose (20 and 15mg, respectively) in 960 patients with primary insomnia. The primary co-endpoints are subjective total sleep time a |
