A Study of BNC210 in Elderly Patients With Agitation

A Phase II Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of BNC210 in Hospitalised Elderly Patients With Agitation

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03548194

Enrollment

Registered

2018-06-07

Start date

2018-05-17

Completion date

2019-04-24

Last updated

2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation in the Elderly

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.

Interventions

DRUGBNC210

BNC210 300 mg b.i.d

DRUGPlacebo

Placebo b.i.d.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS).	5 days

Secondary

Measure	Time frame
Absolute change in global function, as measured by the Clinical Global Impression Scale - Severity and Improvement (CGI-S/I)	5 days
Proportion of participants reaching the Non-Agitated state	5 days
Time to first reach a Non-Agitated state.	5 days

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026