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A Study of BNC210 in Elderly Patients With Agitation

B

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

38 participants in 2 patient groups, including a placebo group

BNC210
Experimental group
Description:
Administered orally b.i.d. for 5 days.
Treatment:
Drug: BNC210
Placebo
Placebo Comparator group
Description:
Administered orally b.i.d. for 5 days.
Treatment:
Drug: Placebo

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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