A Study of BNC210 in Elderly Patients With Agitation
- Registration Number
- NCT03548194
- Lead Sponsor
- Bionomics Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Administered orally b.i.d. for 5 days. BNC210 BNC210 Administered orally b.i.d. for 5 days.
- Primary Outcome Measures
Name Time Method Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS). 5 days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (5)
Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia
Northern Health
🇦🇺Melbourne, Victoria, Australia
Western Health
🇦🇺Melbourne, Victoria, Australia
Prince of Wales Hospital
🇦🇺Sydney, New South Wales, Australia
Modbury Hospital
🇦🇺Adelaide, South Australia, Australia