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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03548194




Registration number
NCT03548194
Ethics application status
Date submitted
27/03/2018
Date registered
7/06/2018
Date last updated
9/07/2020

Titles & IDs
Public title
A Study of BNC210 in Elderly Patients With Agitation
Scientific title
A Phase II Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of BNC210 in Hospitalised Elderly Patients With Agitation
Secondary ID [1] 0 0
BNC210.008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Agitation in the Elderly 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BNC210
Treatment: Drugs - Placebo

Experimental: BNC210 - Administered orally b.i.d. for 5 days.

Placebo Comparator: Placebo - Administered orally b.i.d. for 5 days.


Treatment: Drugs: BNC210
BNC210 300 mg b.i.d

Treatment: Drugs: Placebo
Placebo b.i.d.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS).
Timepoint [1] 0 0
5 days
Secondary outcome [1] 0 0
Absolute change in global function, as measured by the Clinical Global Impression Scale - Severity and Improvement (CGI-S/I)
Timepoint [1] 0 0
5 days
Secondary outcome [2] 0 0
Proportion of participants reaching the "Non-Agitated" state
Timepoint [2] 0 0
5 days
Secondary outcome [3] 0 0
Time to first reach a "Non-Agitated" state.
Timepoint [3] 0 0
5 days

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/04/2019
Sample size
Target
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [2] 0 0
Modbury Hospital - Adelaide
Recruitment hospital [3] 0 0
Northern Health - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [5] 0 0
Western Health - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bionomics Limited
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03548194
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries