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Trial record 2 of 3 for:    bnc210

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 : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Bionomics Limited

Tracking Information
First Submitted Date  ICMJE March 27, 2018
First Posted Date  ICMJE June 7, 2018
Last Update Posted Date July 9, 2020
Actual Study Start Date  ICMJE May 17, 2018
Actual Primary Completion Date April 23, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS). [ Time Frame: 5 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • Absolute change in global function, as measured by the Clinical Global Impression Scale - Severity and Improvement (CGI-S/I) [ Time Frame: 5 days ]
  • Proportion of participants reaching the "Non-Agitated" state [ Time Frame: 5 days ]
  • Time to first reach a "Non-Agitated" state. [ Time Frame: 5 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of BNC210 in Elderly Patients With Agitation
Official Title  ICMJE A Phase II Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of BNC210 in Hospitalised Elderly Patients With Agitation
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Agitation in the Elderly
Intervention  ICMJE
  • Drug: BNC210
    BNC210 300 mg b.i.d
  • Drug: Placebo
    Placebo b.i.d.
Study Arms  ICMJE
  • Experimental: BNC210
    Administered orally b.i.d. for 5 days.
    Intervention: Drug: BNC210
  • Placebo Comparator: Placebo
    Administered orally b.i.d. for 5 days.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2019)
38
Original Estimated Enrollment  ICMJE
 (submitted: May 25, 2018)
40
Actual Study Completion Date  ICMJE April 24, 2019
Actual Primary Completion Date April 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03548194
Other Study ID Numbers  ICMJE BNC210.008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bionomics Limited
Study Sponsor  ICMJE Bionomics Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bionomics Limited
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP