Trials / Completed
CompletedNCT03548194
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Bionomics Limited · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BNC210 | BNC210 300 mg b.i.d |
| DRUG | Placebo | Placebo b.i.d. |
Timeline
- Start date
- 2018-05-17
- Primary completion
- 2019-04-23
- Completion
- 2019-04-24
- First posted
- 2018-06-07
- Last updated
- 2020-07-09
Locations
5 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT03548194. Inclusion in this directory is not an endorsement.