Agitation in the Elderly Clinical Trial
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
| Verified date | July 2020 |
| Source | Bionomics Limited |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 38 |
| Est. completion date | April 24, 2019 |
| Est. primary completion date | April 23, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Modbury Hospital | Adelaide | South Australia |
| Australia | Northern Health | Melbourne | Victoria |
| Australia | Royal Melbourne Hospital | Melbourne | Victoria |
| Australia | Western Health | Melbourne | Victoria |
| Australia | Prince of Wales Hospital | Sydney | New South Wales |
| Lead Sponsor | Collaborator |
|---|---|
| Bionomics Limited |
Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS). | 5 days | ||
| Secondary | Absolute change in global function, as measured by the Clinical Global Impression Scale - Severity and Improvement (CGI-S/I) | 5 days | ||
| Secondary | Proportion of participants reaching the "Non-Agitated" state | 5 days | ||
| Secondary | Time to first reach a "Non-Agitated" state. | 5 days |