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

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 Overview

• Status: Completed
• Conditions: Agitation in the Elderly
• Intervention / Treatment: Drug: BNC210; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
      • Prince of Wales Hospital
  • South Australia
    • Adelaide, South Australia, Australia
      • Modbury Hospital
  • Victoria
    • Melbourne, Victoria, Australia
      • Royal Melbourne Hospital
    • Melbourne, Victoria, Australia
      • Northern Health
    • Melbourne, Victoria, Australia
      • Western Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BNC210; Administered orally b.i.d. for 5 days.	Drug: BNC210; BNC210 300 mg b.i.d
Placebo Comparator: Placebo; Administered orally b.i.d. for 5 days.	Drug: Placebo; Placebo b.i.d.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Bionomics Limited

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2018
• Primary Completion (Actual): April 23, 2019
• Study Completion (Actual): April 24, 2019

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (Actual): June 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation
• Other Study ID Numbers: BNC210.008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No