Clinical Trials Resource Center

Sleep Disorders (Pediatric)

November 14, 2016

Neurim Pharmaceuticals announced results from its NEU_CH_7911 phase III study of PedPRM for prolonged-release melatonin (PedPRM) for sleep disturbances in children with Autism spectrum disorders (ASD). This was a randomized, double-blind, placebo-controlled, parallel group, multicenter (EU and U.S.) study in children with ASD or neurogenetic diseases and sleep disorders. Patients (125), who had not shown improvement practicing sleep hygiene, received two weeks placebo run-in, and then randomized to PedPRM (2mg with optional increase to 5mg) or placebo in the evening, for 13 weeks. Completers received PedPRM open-label for additional 13 weeks. Primary efficacy endpoint was defined as the difference between PedPRM and placebo in mean change from run-in to the end of double-blind treatment period, in parent-reported TST (Daily Sleep and Nap Diary). PedPRM met the primary efficacy endpoint demonstrating statistically significant improvement in total sleep time (TST) compared to placebo. In addition to TST, secondary efficacy endpoints demonstrating improvements in sleep initiation and maintenance were also met. The safety profile was similar between PedPRM and placebo-treated groups.

July 4, 2016

Jazz Pharmaceuticals reported results of a phase III study of JZP-110 for excessive sleepiness (ES) in adult patients with narcolepsy or with obstructive sleep apnea (OSA). The HAL study was a randomized, double-blind, placebo-controlled, six-sequence crossover study evaluating the abuse potential of JZP-110 relative to the Schedule IV stimulant phentermine in 43 adults with a recent history of recreational polydrug use. Subjects were randomized to one of six test sequences, in which they received a single treatment with one of the six study drugs (JZP-110 at 300mg, 600mg and 1200mg; phentermine at 45mg and 90mg; and placebo), with a two-day washout period between each treatment. On the primary endpoint, all doses of JZP-110 had significantly lower ratings of peak (Emax) Liking at the Moment compared to 90mg of phentermine (p<0.05) and had significantly greater ratings of peak Liking at the Moment compared to placebo (p<0.001). On the secondary endpoint of Overall Next Day Drug Liking, JZP-110 at 600mg and at 1200mg had significantly lower measures compared to both doses of phentermine (p<0.05). JZP-110 at 300mg was not statistically different from 45mg of phentermine (p=0.070). JZP-110 at 600mg and at 1200mg did not have any statistical difference in Overall Next Day Drug Liking measures compared to placebo. JZP- 110 at 300mg had higher measures of Overall Next Day Drug Liking at 24 hours compared to placebo (p=0.021). On the secondary endpoint of willingness to Take the Drug Again, JZP-110 at all doses had significantly lower measures compared to both doses of phentermine (p<0.05). All doses of JZP-110 had higher ratings of willingness to Take the Drug Again relative to placebo (p<0.05).

September 20, 2004

Orphan Medical has announced the results of a phase III b study of Xyrem, for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy; Xyrem is currently approved for the treatment of cataplexy, another common symptom of narcolepsy. The study found that the study met its primary endpoint of improving wakefulness and alertness, with a significant improvement over placebo in objective wakefulness score, as measured on a standardized scale. Furthermore, the study also met its secondary endpoint of significantly reducing sleepiness score on another, similar objective standardized scale, compared with placebo. The study also found that while Xyrem was effective alone in limiting EDS, co-administration of Provigil (an approved EDS treatment) yielded greater efficacy than either agent alone. The multi-center, double-blind, placebo-controlled, parallel-group study randomized subjects with established EDS into one of four treatment arms for two weeks: Xyrem alone, Provigil alone, Xyrem and Provigil, or placebo. Orphan Medical announced plans to submit an sNDA for Xyrem for the treatment of EDS.

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