Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-26 @ 8:13 PM
Study NCT ID:
NCT03548194
Status:
COMPLETED
Last Update Posted:
2020-07-09
First Post:
2018-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of BNC210 in Elderly Patients With Agitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-07', 'studyFirstSubmitDate': '2018-03-27', 'studyFirstSubmitQcDate': '2018-05-25', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS).', 'timeFrame': '5 days'}], 'secondaryOutcomes': [{'measure': 'Absolute change in global function, as measured by the Clinical Global Impression Scale - Severity and Improvement (CGI-S/I)', 'timeFrame': '5 days'}, {'measure': 'Proportion of participants reaching the "Non-Agitated" state', 'timeFrame': '5 days'}, {'measure': 'Time to first reach a "Non-Agitated" state.', 'timeFrame': '5 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Agitation in the Elderly']}, 'descriptionModule': {'briefSummary': 'This is a Phase II randomised, double-blind, placebo-controlled study assessing the effects of BNC210 on agitation in hospitalised elderly patients as measured by the Pittsburgh Agitation Scale (PAS). Safety and tolerability of BNC210 will also be assessed.\n\nThe secondary objectives of the study include evaluation of the effects of BNC210 on global function in patients with agitation as assessed by the Clinical Global Impression Scale (CGI-S/I).\n\nParticipants will receive 5 days of blinded treatment followed by 2 days of follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Male or female elderly patient admitted to hospital and under the care of a specialist Geriatrician\n* Determined to have agitation requiring intervention in addition to standard of care behavioural management, as assessed by the Investigator or delegate, after at least 24 hours following admission to hospital.\n\nKey Exclusion Criteria:\n\n* Severe Alzheimer's Dementia (stage 7) as assessed by the Functional Assessment Staging Test (FAST).\n* Diagnosed with Severe Parkinson's Disease.\n* Premorbid psychotic illness as assessed by the Investigator.\n* Evidence of severe organ dysfunction\n* Confirmed metastatic malignancy."}, 'identificationModule': {'nctId': 'NCT03548194', 'briefTitle': 'A Study of BNC210 in Elderly Patients With Agitation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bionomics Limited'}, 'officialTitle': 'A Phase II Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of BNC210 in Hospitalised Elderly Patients With Agitation', 'orgStudyIdInfo': {'id': 'BNC210.008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BNC210', 'description': 'Administered orally b.i.d. for 5 days.', 'interventionNames': ['Drug: BNC210']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Administered orally b.i.d. for 5 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BNC210', 'type': 'DRUG', 'description': 'BNC210 300 mg b.i.d', 'armGroupLabels': ['BNC210']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo b.i.d.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Modbury Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Northern Health', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Western Health', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bionomics Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}