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A Study of BNC210 in Elderly Patients With Agitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03548194
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Bionomics Limited

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.


Condition or disease Intervention/treatment Phase
Agitation in the Elderly Drug: BNC210 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of BNC210 in Hospitalised Elderly Patients With Agitation
Actual Study Start Date : May 17, 2018
Actual Primary Completion Date : April 23, 2019
Actual Study Completion Date : April 24, 2019

Arm Intervention/treatment
Experimental: BNC210
Administered orally b.i.d. for 5 days.
Drug: BNC210
BNC210 300 mg b.i.d

Placebo Comparator: Placebo
Administered orally b.i.d. for 5 days.
Drug: Placebo
Placebo b.i.d.




Primary Outcome Measures :
  1. Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS). [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Absolute change in global function, as measured by the Clinical Global Impression Scale - Severity and Improvement (CGI-S/I) [ Time Frame: 5 days ]
  2. Proportion of participants reaching the "Non-Agitated" state [ Time Frame: 5 days ]
  3. Time to first reach a "Non-Agitated" state. [ Time Frame: 5 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548194


Locations
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Australia, New South Wales
Prince of Wales Hospital
Sydney, New South Wales, Australia
Australia, South Australia
Modbury Hospital
Adelaide, South Australia, Australia
Australia, Victoria
Northern Health
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Western Health
Melbourne, Victoria, Australia
Sponsors and Collaborators
Bionomics Limited

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Responsible Party: Bionomics Limited
ClinicalTrials.gov Identifier: NCT03548194     History of Changes
Other Study ID Numbers: BNC210.008
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms