A Study of BNC210 in Elderly Patients With Agitation

Bionomics

Status and phase

Completed

Phase 2

Conditions

Agitation in the Elderly

Treatments

Drug: BNC210

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03548194

BNC210.008

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.