Slenyto® Clinical Evidence
Slenyto® efficacy was demonstrated in a randomized placebo-controlled, multi-center confirmatory, Phase III trial conducted in 4 countries including 125 pediatric ASD and SMS patients. Patients were aged 2-18 year old and were treated with either Slenyto® (60 patients) or placebo (65 patients) for a period of 13 weeks, followed by a long term follow up (91 weeks) in which all patients were treated with Slenyto® (total of 2 years) with additional 2 weeks placebo run-out period.
28.8% of participants had comorbid ADHD, and 12.8% participants had comorbid epilepsy. Prior ADHD treatment was reported by 10.4% of the participants, antidepressant by 8%, anti-epileptics by 6.4%, clonidine by 5.6%, and β-blockers by 0.8%.
The study was successfully completed demonstrating Slenyto® efficacy in improving children sleep variables (sleep onset, maintenance and total sleep time), children daytime behavior and parents well-being , both in the short- and long-term, demonstrating Slenyto® ability to provide patients with Good Nights and Better Days.
Improves Sleep latency, sleep maintenance and Total Sleep Time
Improves child’s externalizing behaviors (hyperactivity/inattention and conduct)
Improves parents/caregivers Quality of Life
Dose adjustable - 2mg, 5mg, 10mg
Over 75% of patients responded, once dose adjusted
Benefit was similar in all age groups, from 2 to 18 years
Compliance was close to 100% throughout the study
Slenyto®’s prolonged release properties improves both sleep initiation and sleep maintenance, resulting in increased total sleep time without early awakenings, in comparison to immediate release preparations which improve only sleep initiation and cause early awakenings.
Slenyto® improves Total Sleep Time
Slenyto® significantly improves Total Sleep Time (TST) by 57.5 mins vs. 9.1 mins on Placebo at 3 months. A 6-fold greater improvement
Slenyto® shortens Sleep Latency
Slenyto® significantly shortened Sleep Latency by 39.6 mins (-41.5%) vs 12.5 mins (-12.6%) on Placebo at 3 months
Slenyto® improves Sleep Maintenance
Slenyto® increased longest sleep duration by 77.9 mins compared to 25.4 mins for placebo at 3 months
Alleviation of a child or adolescent sleep and behavior should also have a positive effect on their parents’ satisfaction with their treatment and overall Quality of Life.
Slenyto® improves parents' satisfaction from child sleep
Parents’ satisfaction with their child's sleep increased significantly with Slenyto® by an average of almost 2 units on a scale of 1-5
Slenyto® improves caregiver’s Quality of Life (QoL)
Almost 50% of caregivers experienced a clinically relevant improvement with Slenyto® of 10% over baseline QoL score at 6 and 12 month