Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT06953869
Status:
RECRUITING
Last Update Posted:
2025-05-01
First Post:
2025-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2025-04-01', 'studyFirstSubmitQcDate': '2025-04-23', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in sleep latency, as measured by daily sleep diary.', 'timeFrame': '12 Weeks'}], 'secondaryOutcomes': [{'measure': 'Change in nighttime subjective sleep parameters, such as sleep quality, as measured by sleep diary.', 'timeFrame': '12 Weeks'}, {'measure': 'Change in nighttime subjective sleep parameters, such as sleep time, as measured by sleep diary.', 'timeFrame': '12 Weeks'}, {'measure': 'Change in daytime functioning, as measured by questionnaire.', 'timeFrame': '12 Weeks'}, {'measure': 'Change in behavior, as measured by questionnaire.', 'timeFrame': '12 Weeks'}, {'measure': 'Change in nighttime objective sleep parameters such as sleep time, as measured by actigraphy.', 'timeFrame': '12 Weeks'}, {'measure': 'Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).', 'timeFrame': '12 Weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insomnia Disorder']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required).\n* Confirmed clinical diagnosis of insomnia disorder\n* Males and Females between 2 and 17 years, inclusive.\n* The sleep disturbance must not be a result of another medication.\n\nExclusion Criteria:\n\n* Inability to dose daily with tasimelteon or previous intolerance to tasimelteon.\n* Indication of impaired liver function.\n* Pregnant or lactating females.\n* A positive test for drugs of abuse.'}, 'identificationModule': {'nctId': 'NCT06953869', 'briefTitle': 'Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vanda Pharmaceuticals'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia', 'orgStudyIdInfo': {'id': 'VP-VEC-162-3108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tasimelteon', 'interventionNames': ['Drug: Tasimelteon Oral Suspension']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tasimelteon Oral Suspension', 'type': 'DRUG', 'description': 'Single daily dose, weight-based liquid suspension formulation.', 'armGroupLabels': ['Tasimelteon']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo comparator.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanda Pharmaceuticals', 'role': 'CONTACT'}], 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '28277', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanda Pharmaceuticals', 'role': 'CONTACT'}], 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanda Pharmaceuticals', 'role': 'CONTACT'}], 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Vanda Pharmaceuticals, Inc.', 'role': 'CONTACT', 'email': 'VEC162@vandapharma.com', 'phone': '202-734-3400'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanda Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}