Agitation in the ElderlyPhase 2NCT03548194
A Study of BNC210 in Elderly Patients With Agitation
A Phase 2 study testing BNC210 in people with Agitation in the Elderly, run by Bionomics Limited at 5 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Agitation in the Elderly
- What is being tested?
- BNC210
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 5 sitesAustralia
- Study dates
- 17 May 2018to 24 Apr 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Modbury Hospital
Adelaide, South Australia
Northern Health
Melbourne, Victoria
Royal Melbourne Hospital
Melbourne, Victoria
Western Health
Melbourne, Victoria
Prince of Wales Hospital
Sydney, New South Wales
About this study
Official title: 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.
- Conditions
- Agitation in the Elderly
- Being tested
- BNC210, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNC210Drug
BNC210 300 mg b.i.d
PlaceboDrug
Placebo b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| BNC210 | Experimental | Administered orally b.i.d. for 5 days. Receives: Drug: BNC210 |
| Placebo | Placebo comparator | Administered orally b.i.d. for 5 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS).
Measured: 5 days
Secondary outcomes (3)
Absolute change in global function, as measured by the Clinical Global Impression Scale - Severity and Improvement (CGI-S/I)
Measured: 5 days
Proportion of participants reaching the "Non-Agitated" state
Measured: 5 days
Time to first reach a "Non-Agitated" state.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start17 May 2018
- Primary completion23 Apr 2019
- Study completion24 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Agitation in the ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionomics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548194
- Sponsor's protocol ID
- BNC210.008
- Status last verified
- Jul 2020
- First submitted
- 27 Mar 2018
- Last updated
- 9 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of BNC210 in Hospitalised Elderly Patients With Agitation
- ClinicalTrials.gov ID
- NCT03548194
- Acronym / sponsor ID
- BNC210.008
- Conditions
- Agitation in the Elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Bionomics LimitedIndustry (pharma, biotech, devices)
- Study start
- 17 May 2018 (actual)
- Primary completion
- 23 Apr 2019 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 7 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BNC210 | Experimental | Drug: BNC210Administered orally b.i.d. for 5 days. |
| Placebo | Placebo comparator | Drug: PlaceboAdministered orally b.i.d. for 5 days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNC210BNC210 300 mg b.i.d | Drug | BNC210 |
| PlaceboPlacebo b.i.d. | Drug | Placebo |
Primary outcome
Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS).
Time frame: 5 days
3 secondary outcomes
Absolute change in global function, as measured by the Clinical Global Impression Scale - Severity and Improvement (CGI-S/I)
Time frame: 5 days
Proportion of participants reaching the "Non-Agitated" state
Time frame: 5 days
Time to first reach a "Non-Agitated" state.
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
Related trials for Agitation in the Elderly
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BNC210 in people with Agitation in the Elderly, run by Bionomics Limited at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS). (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020; AzTrials last refreshed its copy on 7 Nov 2026.