A Study of BNC210 in Elderly Patients With Agitation | NCT03548194

Studies
A Study of BNC210 in Elderly Patients With Agitation

NCT03548194

Sponsor

Bionomics Limited

Status

Completed

Last Update Posted

Jul 9, 2020Actual

Enrollment

38Actual

Phase

Phase 2

Conditions

Agitation in the Elderly

Interventions

BNC210
Placebo

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 17, 2018Actual

Primary Completion Date

Apr 23, 2019Actual

Completion Date

Apr 24, 2019Actual

First Submitted Date

Mar 27, 2018

First Submission Date that Met QC Criteria

May 25, 2018

First Posted Date

Jun 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2020

Last Update Posted Date

Jul 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BNC210	Experimental	Administered orally b.i.d. for 5 days.	Drug: BNC210
Placebo	Placebo Comparator	Administered orally b.i.d. for 5 days.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BNC210	Drug	BNC210 300 mg b.i.d	BNC210
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital		Sydney	New South Wales		Australia
Modbury Hospital