Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-03-02 @ 8:05 AM
Study NCT ID:
NCT03814135
Status:
WITHDRAWN
Last Update Posted:
2021-04-01
First Post:
2019-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Two Doses of Hipnos in the Treatment of Adults With 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Duble-blind and double-dummy'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-30', 'studyFirstSubmitDate': '2019-01-22', 'studyFirstSubmitQcDate': '2019-01-22', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in sleep latency time, obtained through polysomnography, performed before and at the end of treatment.', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Incidence and severity of adverse events recorded during the study.', 'timeFrame': '5 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['insomnia'], 'conditions': ['Insomnia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of three doses of Hipnos medication in adults with insomnia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants aged 50 years or more;\n* Diagnosis of insomnia disorder according to criteria defined by the DSM-V;\n* Sleep latency ≥ 20 minutes obtained through polysomnography performed prior to the randomization visit.\n\nExclusion Criteria:\n\n* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;\n* Known hypersensitivity to the formula components used during the clinical trial;\n* Decompensated diabetes mellitus, hypothyroidism or hyperthyroidism;\n* History of hepatic impairment;\n* Current smoking;\n* Pregnancy or risk of pregnancy and lactating patients;\n* History of sleep-disordered breathing, sleep disorders associated with changes in circadian rhythm and severe neurological and psychiatric disorders;\n* Diagnosis of clinical diseases that interfere with sleep;\n* Participants who have used psychostimulant medications, antidepressants and/ or antipsychotic with sedative effects and/or antiepileptic;\n* Participation in clinical trial in the year prior to this study.'}, 'identificationModule': {'nctId': 'NCT03814135', 'briefTitle': 'Efficacy and Safety of Two Doses of Hipnos in the Treatment of Adults With Insomnia', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': 'Randomized, Double-blind, Double-dummy, National, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Two Doses of Hipnos Medication in the Treatment of Adults With Insomnia', 'orgStudyIdInfo': {'id': 'EMS0518 - HIPNOS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIPNOS 3', 'description': 'The study is double-dummy. Thus, the patient will take 2 tablets, as follow:\n\n1 tablet Hipnos 3 and 1 placebo tablet, oral, once a day.', 'interventionNames': ['Drug: Hipnos 3', 'Other: Hipnos 5 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'HIPNOS 5', 'description': 'The study is double-dummy. Thus, the patient will take 2 tablets, as follow:\n\n1 tablet Hipnos 5 and 1 placebo tablet, oral, once a day.', 'interventionNames': ['Drug: Hipnos 5', 'Other: Hipnos 3 Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'HIPNOS Placebo', 'description': 'The study is double-dummy. Thus, the patient will take 2 tablet of placebo, oral, once a day.', 'interventionNames': ['Other: Hipnos 5 Placebo', 'Other: Hipnos 3 Placebo']}], 'interventions': [{'name': 'Hipnos 3', 'type': 'DRUG', 'otherNames': ['EMS tablet'], 'description': '1 tablet, oral, once a day.', 'armGroupLabels': ['HIPNOS 3']}, {'name': 'Hipnos 5', 'type': 'DRUG', 'otherNames': ['EMS tablet'], 'description': '1 tablet, oral, once a day.', 'armGroupLabels': ['HIPNOS 5']}, {'name': 'Hipnos 5 Placebo', 'type': 'OTHER', 'otherNames': ['Placebo'], 'description': '1 tablet, oral, once a day.', 'armGroupLabels': ['HIPNOS 3', 'HIPNOS Placebo']}, {'name': 'Hipnos 3 Placebo', 'type': 'OTHER', 'otherNames': ['Placebo'], 'description': '1 tablet, oral, once a day.', 'armGroupLabels': ['HIPNOS 5', 'HIPNOS Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}