Efficacy and Safety of Slenyto for Insomnia in Children With ASD

NCT04233502 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: NEU_CH_7913
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Total Sleep Time (TST)

  the change from baseline in average TST time as assessed by a Sleep and Nap Diary

  after the 3 weeks (Week 5) of double blind treatment

Secondary Outcomes (2)

• Sleep Latency (SL)

  after 3 weeks (Week 5) of double blind treatment

• Longest Sleep Episode (LSE)

  after 3 weeks (Week 5) of double blind treatment

Study Arms (2)

Melatonin

EXPERIMENTAL

Slenyto® 1 mg / 5 mg prolonged release Melatonin tablets (pink and yellow) film coated 3 mm in diameter,

Drug: Melatonin

Placebo melatonin

PLACEBO COMPARATOR

Placebo melatonin will be identical in appearance (pink and yellow) and formulation to active Slenyto® tablets, but will contain no active melatonin.

Drug: Placebo

Interventions

Melatonin DRUG

prolonged release 1 mg and 5 mg mini-tablets coated odorless and tasteless to facilitate swallowing

Also known as: Slenyto

Melatonin

Placebo DRUG

Placebo melatonin

Placebo melatonin

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurim Pharmaceuticals Ltd.: lead

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 12, 2021

Record last verified: 2020-01