Back to resultsA Study of BNC210 in Elderly Patients With Agitation
Primary Purpose
Agitation in the Elderly
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
BNC210
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Agitation in the Elderly
Eligibility Criteria
Key Inclusion Criteria:
- Male or female elderly patient admitted to hospital and under the care of a specialist Geriatrician
- 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.
Key Exclusion Criteria:
- Severe Alzheimer's Dementia (stage 7) as assessed by the Functional Assessment Staging Test (FAST).
- Diagnosed with Severe Parkinson's Disease.
- Premorbid psychotic illness as assessed by the Investigator.
- Evidence of severe organ dysfunction
- Confirmed metastatic malignancy.
Sites / Locations
- Prince of Wales Hospital
- Modbury Hospital
- Northern Health
- Royal Melbourne Hospital
- Western Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BNC210
Placebo
Arm Description
Administered orally b.i.d. for 5 days.
Administered orally b.i.d. for 5 days.
Outcomes
Primary Outcome Measures
Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS).
Secondary Outcome Measures
Absolute change in global function, as measured by the Clinical Global Impression Scale - Severity and Improvement (CGI-S/I)
Proportion of participants reaching the "Non-Agitated" state
Time to first reach a "Non-Agitated" state.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03548194
Brief Title
A Study of BNC210 in Elderly Patients With Agitation
Official Title
A Phase II Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of BNC210 in Hospitalised Elderly Patients With Agitation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 17, 2018 (Actual)
Primary Completion Date
April 23, 2019 (Actual)
Study Completion Date
April 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bionomics Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
The 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).
Participants will receive 5 days of blinded treatment followed by 2 days of follow up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation in the Elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BNC210
Arm Type
Experimental
Arm Description
Administered orally b.i.d. for 5 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered orally b.i.d. for 5 days.
Intervention Type
Drug
Intervention Name(s)
BNC210
Intervention Description
BNC210 300 mg b.i.d
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo b.i.d.
Primary Outcome Measure Information:
Title
Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS).
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Absolute change in global function, as measured by the Clinical Global Impression Scale - Severity and Improvement (CGI-S/I)
Time Frame
5 days
Title
Proportion of participants reaching the "Non-Agitated" state
Time Frame
5 days
Title
Time to first reach a "Non-Agitated" state.
Time Frame
5 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Male or female elderly patient admitted to hospital and under the care of a specialist Geriatrician
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.
Key Exclusion Criteria:
Severe Alzheimer's Dementia (stage 7) as assessed by the Functional Assessment Staging Test (FAST).
Diagnosed with Severe Parkinson's Disease.
Premorbid psychotic illness as assessed by the Investigator.
Evidence of severe organ dysfunction
Confirmed metastatic malignancy.
Facility Information:
Facility Name
Prince of Wales Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Modbury Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Northern Health
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Western Health
City
Melbourne
State/Province
Victoria
Country
Australia
12. IPD Sharing Statement
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A Study of BNC210 in Elderly Patients With Agitation
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