A Study of BNC210 in Elderly Patients With Agitation

NCT03548194 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-07-09

No results posted yet for this study

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

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

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03548194 on ClinicalTrials.gov