Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2018-05-17
2019-04-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BNC210
Administered orally b.i.d. for 5 days.
BNC210
BNC210 300 mg b.i.d
Placebo
Administered orally b.i.d. for 5 days.
Placebo
Placebo b.i.d.
Interventions
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BNC210
BNC210 300 mg b.i.d
Placebo
Placebo b.i.d.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Diagnosed with Severe Parkinson's Disease.
* Premorbid psychotic illness as assessed by the Investigator.
* Evidence of severe organ dysfunction
* Confirmed metastatic malignancy.
ALL
No
Sponsors
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Bionomics Limited
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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BNC210.008
Identifier Type: -
Identifier Source: org_study_id
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