A Phase II Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of BNC210 in Hospitalised Elderly Patients With Agitation
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Bionomics Limited
- Enrollment
- 38
- Locations
- 5
- Primary Endpoint
- Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Arms & Interventions
BNC210
Administered orally b.i.d. for 5 days.
Intervention: BNC210 (Drug)
Placebo
Administered orally b.i.d. for 5 days.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS).
Time Frame: 5 days
Secondary Outcomes
- Proportion of participants reaching the "Non-Agitated" state(5 days)
- Time to first reach a "Non-Agitated" state.(5 days)
- Absolute change in global function, as measured by the Clinical Global Impression Scale - Severity and Improvement (CGI-S/I)(5 days)