Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT04233502
Status:
WITHDRAWN
Last Update Posted:
2021-03-12
First Post:
2020-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Slenyto for Insomnia in Children With ASD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was not initiated it was decided to cancel this study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-10', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Sleep Time (TST)', 'timeFrame': 'after the 3 weeks (Week 5) of double blind treatment', 'description': 'the change from baseline in average TST time as assessed by a Sleep and Nap Diary'}], 'secondaryOutcomes': [{'measure': 'Sleep Latency (SL)', 'timeFrame': 'after 3 weeks (Week 5) of double blind treatment', 'description': '• Change from baseline in average SL as assessed by a Sleep and Nap Diary'}, {'measure': 'Longest Sleep Episode (LSE)', 'timeFrame': 'after 3 weeks (Week 5) of double blind treatment', 'description': '• Change from baseline in average LSE from the Sleep and Nap Diary .'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': '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. .\n\nThe 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.', 'detailedDescription': 'This is a randomized placebo controlled study in children diagnosed with autism spectrum disorder (ASD). Children will have a documented history of this disorder, as confirmed or consistent with the International Classification of Diseases (ICD 10) or Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (Text Revision; DSM 5) criteria, having DSM-5 criteria based sleep disturbances at screening.\n\nThe children will undergo 4 weeks of basic sleep hygiene and behavioral intervention, which will serve as a wash out period from any hypnotics and prohibited medications; Children with a documented history of sleep hygiene and behavioral intervention who are taking a prohibited medication will not require additional training and will undergo a 2-week wash out period before Visit 1.\n\nChildren who are still found to be eligible for the study after the 4 week, basic sleep hygiene and behavioral intervention wash out period, will continue in a 2 week single blind (SB) placebo run in period.\n\n. After the 2 week SB placebo run in period (Visit 2; Week 2), children who are still found eligible for study participation will be randomized in a 1:1 ratio to receive either Slenyto® (1 or 5 mg prolonged release melatonin tablets) or placebo for 3 weeks double-blind treatment period. The starting dose will be 2X1mg Slenyto® or matching placebo. During these 3 weeks parents will complete the electronic sleep and nap diary every morning.\n\nAfter one week of double-blind treatment, on the last day of Week 3 ±3 days (Visit 3), sleep variables will be assessed to determine if dose modification (increase to 1X5 mg Slenyto® or matching placebo) is required. Children will then continue on 2 or 5 mg of Slenyto® or matching placebo to the end of the double blind period (End-of Study Visit 4; Week 5).\n\nStudy duration will be either 5, 7, or 9 weeks, including the optional 2-weeks medication wash out and 4 weeks sleep hygiene and behavioral intervention periods (overlapping).\n\nThe 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.\n\nThe key secondary endpoints are SL and LSE. Safety will also be assessed by Adverse events, vital signs and physical examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children 2 to 17.5 years of age at Visit 2 who comply with taking the study drug\n* Written informed consent provided by a legal guardian and assent (if needed)\n* 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.\n* 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.)\n* 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\n* The sleep disturbance is not due to the direct physiological effects of any concomitant medications such as SSRIs, β blockers etc.\n\nExclusion Criteria:\n\n* Have had treatment with any form of melatonin within 2 weeks prior to Visit\n* Have a known allergy to melatonin or lactose\n* Have a known moderate to severe sleep apnea\n* Have an untreated medical/ineffectively treated/psychological condition that may be the etiology of sleep disturbances\n* Are taking or have been taking prohibited medication within 2 weeks prior to Visit 1\n* 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.)\n* Pregnant females\n* 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\n* Participated in Study NEU\\_CH\\_7911\n* Children with known renal or hepatic insufficiency'}, 'identificationModule': {'nctId': 'NCT04233502', 'acronym': 'ASD', 'briefTitle': 'Efficacy and Safety of Slenyto for Insomnia in Children With ASD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurim Pharmaceuticals Ltd.'}, 'officialTitle': 'A Randomized, Placebo Controlled Study to Investigate the Efficacy and Safety of Slenyto® to Alleviate Sleep Disturbances in Children With Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': 'NEU_CH_7913'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Melatonin', 'description': 'Slenyto® 1 mg / 5 mg prolonged release Melatonin tablets (pink and yellow) film coated 3 mm in diameter,', 'interventionNames': ['Drug: Melatonin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo melatonin', 'description': 'Placebo melatonin will be identical in appearance (pink and yellow) and formulation to active Slenyto® tablets, but will contain no active melatonin.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Melatonin', 'type': 'DRUG', 'otherNames': ['Slenyto'], 'description': 'prolonged release 1 mg and 5 mg mini-tablets coated odorless and tasteless to facilitate swallowing', 'armGroupLabels': ['Melatonin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo melatonin', 'armGroupLabels': ['Placebo melatonin']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurim Pharmaceuticals Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}