BioCentury
ARTICLE | Clinical News

Neurim's PedPRM meets in Phase III for insomnia in children with autism

February 16, 2018 5:28 PM UTC

In October, Neurim Pharmaceuticals Ltd. (Tel Aviv, Israel) reported data from a Phase III trial in 125 children ages 2-18 with autism or neurogenetic diseases and insomnia showing that PedPRM melatonin met the primary endpoint of increasing parent-reported total sleep time vs. placebo (p=0.034). Specifically, PedPRM increased total sleep time from run-in baseline by 57.5 minutes vs. 9.14 minutes for placebo. On a secondary endpoint, PedPRM reduced sleep latency by 39.6 minutes vs. 12.5 minutes for placebo (p=0.011). Data were presented at the World Sleep Congress in Prague.

The double-blind, international trial enrolled patients who had not shown improvement after standard sleep behavioral intervention to receive placebo during a two-week run-in, followed by either placebo or once-daily 2 mg PedPRM (with an optional increase to 5 mg) for 13 weeks. Patients received open-label PedPRM for another 13 weeks and are being followed up to 78 weeks to assess long-term efficacy and safety...