A Study of BNC210 in Elderly Patients With Agitation
A Phase II Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of BNC210 in Hospitalised Elderly Patients With Agitation
1 other identifier
interventional
38
1 country
5
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2018
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2018
CompletedStudy Start
First participant enrolled
May 17, 2018
CompletedFirst Posted
Study publicly available on registry
June 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2019
CompletedJuly 9, 2020
July 1, 2020
11 months
March 27, 2018
July 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS).
5 days
Secondary Outcomes (3)
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
Time to first reach a "Non-Agitated" state.
5 days
Study Arms (2)
BNC210
EXPERIMENTALAdministered orally b.i.d. for 5 days.
Placebo
PLACEBO COMPARATORAdministered orally b.i.d. for 5 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Prince of Wales Hospital
Sydney, New South Wales, Australia
Modbury Hospital
Adelaide, South Australia, Australia
Northern Health
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Western Health
Melbourne, Victoria, Australia
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2018
First Posted
June 7, 2018
Study Start
May 17, 2018
Primary Completion
April 23, 2019
Study Completion
April 24, 2019
Last Updated
July 9, 2020
Record last verified: 2020-07