Efficacy and Safety of Slenyto for Insomnia in Children With ASD

• Status: Withdrawn
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized placebo controlled study in children diagnosed with autism spectrum disorder (ASD), to Investigate the Efficacy and Safety of Slenyto® to alleviate Sleep Disturbances in these children. .

The main objective is to compare treatment effect of Slenyto® 2 mg or 5 mg to that of placebo on sleep duration (total sleep time [TST]) as assessed by the Sleep and Nap Diary after 3 weeks of double blind treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurim Pharmaceuticals Ltd.
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• children 2 to 17.5 years of age at Visit 2 who comply with taking the study drug

• Written informed consent provided by a legal guardian and assent (if needed)

• A documented history of ASD according to or consistent with the ICD 10 or DSM 5 criteria, as confirmed by case note review showing that diagnosis was reached through assessment by a community pediatrician or pediatric neurologist or other health care professionals experienced in the diagnosis who took into account early developmental history and school records.

• Current sleep problems consistent with DSM-5 criteria including: a minimum of 3 months of impaired sleep defined as ≤6 hours of continuous sleep AND ≥ 0.5-hour sleep latency from light off in 3 out of 5 nights based on parent reports and subject medical history. (The maintenance and latency problems do not necessarily have to be in the same 3 nights of the week.)

• May be on a stable dose of non excluded medication for 3 months, including anti epileptics, anti depressants (selective serotonin reuptake inhibitor [SSRIs]), and β blockers. (Only morning administration of β blockers is allowed since β blockers at night have the potential to reduce endogenous

• The sleep disturbance is not due to the direct physiological effects of any concomitant medications such as SSRIs, β blockers etc.

Exclusion Criteria:

• Have had treatment with any form of melatonin within 2 weeks prior to Visit

• Have a known allergy to melatonin or lactose

• Have a known moderate to severe sleep apnea

• Have an untreated medical/ineffectively treated/psychological condition that may be the etiology of sleep disturbances

• Are taking or have been taking prohibited medication within 2 weeks prior to Visit 1

• Are females of child bearing potential that are not using contraceptives and/or breastfeeding and that are sexually active (Abstinence is an acceptable method of contraception.)

• Pregnant females

• Are currently participating in a clinical trial or have participated in a clinical trial involving medicinal product within the last 3 months prior to the study

• Participated in Study NEU_CH_7911

• Children with known renal or hepatic insufficiency