Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-30 @ 12:42 PM
Study NCT ID:
NCT04674735
Status:
WITHDRAWN
Last Update Posted:
2022-04-26
First Post:
2020-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008575', 'term': 'Meniere Disease'}, {'id': 'D014717', 'term': 'Vertigo'}], 'ancestors': [{'id': 'D018159', 'term': 'Endolymphatic Hydrops'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Cancelled by Sponsor', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-19', 'studyFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2020-12-14', 'lastUpdatePostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events', 'timeFrame': 'during 60 days'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic parameters in steady state', 'timeFrame': 'at Day 60', 'description': 'Cmáx\\_SS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meniere Disease', 'Vertigo', 'Vertigo Vestibular']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the safety of APSLXR in participants with Meniere's disease or other Verigo of vestibular origin. Pharmacokinetics will also be evaluated in a small group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Meniere's Disease or Vertigo of Vestibular Origin;\n* Voluntarily consent to participate in the study;\n\nExclusion Criteria:\n\n* Female patients who are pregnant or breastfeeding;\n* Participants presenting uncontroled systolic hipertension (\\>140/90 mmHg);\n* Participants presenting uncontroled diabetes (blood glucose \\>200 mg/dL)."}, 'identificationModule': {'nctId': 'NCT04674735', 'briefTitle': "Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Apsen Farmaceutica S.A.'}, 'officialTitle': "Multicentre, Open Label, Phase I Clinical Trial to Evaluate the Safety of APSLXR for the Treatment of Vertigo of Vestibular Origin or Meniere's Disease", 'orgStudyIdInfo': {'id': 'APS004/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APSLXR', 'interventionNames': ['Drug: APSLXR']}], 'interventions': [{'name': 'APSLXR', 'type': 'DRUG', 'description': 'Oral coated tablets once a day for 60 days.', 'armGroupLabels': ['APSLXR']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apsen Farmaceutica S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}