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Completed

NCT Number: NCT03548194

A Study of BNC210 in 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.

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Key information

Conditions

Agitation in the Elderly

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Prince of Wales Hospital, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BNC210

Drug

BNC210 300 mg b.i.d

Placebo

Drug

Placebo b.i.d.

Primary outcomes

  1. Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS).

    Time frame: 5 days

Secondary outcomes

  1. Absolute change in global function, as measured by the Clinical Global Impression Scale - Severity and Improvement (CGI-S/I)

    Time frame: 5 days

  2. Proportion of participants reaching the "Non-Agitated" state

    Time frame: 5 days

  3. Time to first reach a "Non-Agitated" state.

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Bionomics Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2018
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.