A Study of BNC210 in Elderly Patients With Agitation
NCT03548194 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2020-07-09
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.
Conditions
- Agitation in the Elderly
Interventions
- DRUG
-
BNC210
BNC210 300 mg b.i.d
- DRUG
-
Placebo b.i.d.
Sponsors & Collaborators
-
Bionomics Limited
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-17
- Primary Completion
- 2019-04-23
- Completion
- 2019-04-24
Countries
- Australia
Study Locations
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