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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02933606
Registration number
NCT02933606
Ethics application status
Date submitted
1/09/2016
Date registered
14/10/2016
Date last updated
27/02/2023
Titles & IDs
Public title
Phase II Study of BNC210 in PTSD
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Scientific title
A Randomized, Double-blind, Placebo-controlled Phase II Study of BNC210 in Adults With Post-Traumatic Stress Disorder (PTSD).
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Secondary ID [1]
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BNC210.007
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Universal Trial Number (UTN)
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Trial acronym
RESTORE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Post-Traumatic Stress Disorder
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Condition category
Condition code
Mental Health
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Anxiety
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Mental Health
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Other mental health disorders
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Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BNC210
Treatment: Drugs - Placebo
Experimental: BNC210 600 mg b.i.d. - Suspension administered orally for 12 weeks.
Experimental: BNC210 300 mg b.i.d. - Suspension administered orally for 12 weeks.
Experimental: BNC210 150 mg b.i.d. - Suspension administered orally for 12 weeks.
Placebo Comparator: Placebo b.i.d. - Suspension administered orally for 12 weeks.
Treatment: Drugs: BNC210
Treatment: Drugs: Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5), Total Symptom Severity Score
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Assessment method [1]
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Investigator-rated PTSD symptom severity.
The range for the Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5)Total Symptom Severity Score is 0-80, with a higher score meaning a higher severity of disease.
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Timepoint [1]
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12 weeks.
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Secondary outcome [1]
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Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5).
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Assessment method [1]
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Self-reported PTSD symptom severity.
The range for the Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5) Symptom Severity Score is 0-80, with a higher score meaning a higher severity of disease.
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Timepoint [1]
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12 weeks.
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Secondary outcome [2]
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Montgomery- Åsberg Depression Rating Scale (MADRS).
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Assessment method [2]
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Depression severity.
The range for the Montgomery- Åsberg Depression Rating Scale (MADRS) is 0-60, with a higher score meaning a higher severity of disease.
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Timepoint [2]
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12 weeks.
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Secondary outcome [3]
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Hamilton Anxiety Rating Scale (HAM-A).
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Assessment method [3]
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Anxiety severity.
The range for the Hamilton Anxiety Rating Scale (HAM-A) is 0-56, with a higher score meaning a higher severity of disease.
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Timepoint [3]
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12 weeks
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Secondary outcome [4]
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Clinical Global Impressions - Severity Scale (CGI-S).
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Assessment method [4]
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Clinician's assessment of global symptom severity using the Clinical Global Impressions - Severity Scale (CGI-S).
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Timepoint [4]
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12 weeks
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Secondary outcome [5]
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Clinical Global Impressions - Improvement Scale (CGI-I).
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Assessment method [5]
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Clinician's assessment of global symptom improvement using the Clinical Global Impressions - Improvement Scale (CGI-I).
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Timepoint [5]
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12 weeks
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Secondary outcome [6]
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Patient Global Impressions - Severity Scale (PGI-S).
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Assessment method [6]
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Self-reported global symptom severity using the Patient Global Impressions - Severity Scale (CGI-S).
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Timepoint [6]
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12 weeks.
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Secondary outcome [7]
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Patient Global Impression - Improvement Scale (PGI-I).
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Assessment method [7]
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Self-reported global symptom improvement using the Patient Global Impression - Improvement Scale (PGI-I).
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Timepoint [7]
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12 weeks.
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Secondary outcome [8]
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Assessment of Quality of Life (AQoL-8D).
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Assessment method [8]
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Quality of Life.
The range for the Assessment of Quality of Life (AQoL-8D) score is 35-176, with a higher score meaning a lower quality of life.
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Timepoint [8]
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12 weeks.
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Secondary outcome [9]
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Social Functioning: Sheehan Disability Scale (SDS).
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Assessment method [9]
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Social functioning.
The range for the Total Score on the Sheehan Disability Scale (SDS) is 0-30, with a higher score meaning a higher degree of impairment.
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Timepoint [9]
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12 weeks.
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Secondary outcome [10]
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Sleep Monitoring: Pittsburgh Sleep Quality Index (PSQI).
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Assessment method [10]
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Sleep quality and duration.
The range for the Pittsburgh Sleep Quality Index (PSQI) score is 0-21, with a higher score meaning a worse level of sleep quality
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Timepoint [10]
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12 weeks.
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Secondary outcome [11]
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CANTAB (Cambridge Neuropsychological Test Automated Battery) Cognitive Assessment
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Assessment method [11]
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The CANTAB global composite score is based on the Z scores for CANTAB outcome measures (PAL first attempt memory score (PALFAMS), PAL total errors adjusted (PALTEA), SWM between errors (SWMBE), SWM strategy (SWMS), RVP A' prime (RVPA), RVP median latency (RVPMDL). Specifically, the global composite score of cognitive function is as follows: CANTAB global composite score of cognitive function = (ZPALFAMS + ZPALTEA + ZSWMBE + ZSWMS + ZRVPA + ZRVPMDL) /8 (higher is better)
A Z-score of 0 represents the population mean. A Z-score above 0 indicates cognition higher than the population mean and Z-score below 0 indicates cognition lower than the population mean
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Timepoint [11]
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12 Weeks
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Eligibility
Key inclusion criteria
Key
- Signed and dated informed consent.
- Male or female between 18 and 70 years of age, inclusive.
- Diagnosed with current PTSD as defined by the CAPS-5 for DSM-5.
- Currently not using any psychiatric medications except for:
- No more than one selective serotonin reuptake inhibitor (SSRI) (fluvoxamine is
excluded) or serotonin noradrenaline reuptake inhibitor (SNRI) within the
licensed prescribing dose range. Subjects must have been on a stable dose for at
least 3 months prior and through Screening, with the intent to remain on the same
dose through to Week 16.
- As needed (PRN) use of benzodiazepines (BZD) at a frequency not exceeding 2 days
per week in the 3 months prior to Screening. The total dose must not exceed 30
mg/day in diazepam equivalents.
- Subjects not currently receiving psychotherapy except long term supportive counseling
or subjects that have received intensive regular psychotherapy for a minimum of three
months prior to Screening.
- Females of childbearing potential must have a negative serum pregnancy. Females not of
childbearing potential must be postmenopausal. Sterilized male patients must be at
least 1 year post-vasectomy to be considered of non-child bearing potential. Females
and males of childbearing potential must agree to use two effective methods of
contraception.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
- Current and ongoing exposure to the trauma that caused the PTSD.
- Failed more than three trials of antidepressant medication(s) prescribed for the
treatment of PTSD. Each trial must have lasted at least 6 weeks to be considered a
failed attempt. A trial that was terminated due to intolerability or side effects does
not constitute a failed attempt.
- The use of psychiatric medications within 2 weeks of Screening except for SSRIs, SNRIs
or limited PRN BZD use as per inclusion criterion 4. Restricted psychiatric
medications include (but are not limited to) antidepressants not allowed by inclusion
criterion 4, antianxiety drugs (except limited BZD use per inclusion criterion 4),
mood stabilizers, stimulants, antipsychotics, hypnotics and acetylcholinesterase
inhibitors.
- History of significant traumatic brain injury.
- Depression as measured by Montgomery-Äsberg depression scale (MADRS) rating > 23.
- Bipolar and psychotic disorders as identified at Screening using the MINI
International Neuropsychiatry Interview (V7.0) (M.I.N.I).
- A score = 7 on the McLean Screening Instrument for Borderline Personality Disorder
(MSI-BPD) at Screening.
- History of seizure disorders, uncontrolled sleep apnoea or severe neurologic disease.
- Increased risk of suicide, defined as:
- Any previous suicide attempt disclosed by the participant at Screening using the
Columbia Suicide Severity Rating Scale (C-SSRS).
- Any suicidal ideation with intent (yes to item 4 and / or 5) or suicidal behavior
in the past year, as captured at Screening using the C-SSRS.
- A score > 4 on item 10 of the MADRS at Screening.
- The use of alprazolam or flunitrazepam within 3 months of Screening.
- Any clinically significant abnormalities in laboratory test results, vitals signs, or
ECG at Screening.
- Positive result for human immunodeficiency virus (HIV), hepatitis B surface antigen
(HBsAg), or hepatitis C (HCV) at Screening.
- Any moderate to severe substance use disorder (any type) in the 12 months prior to
Screening as identified by the DSM-5 using the M.I.N.I (V7.0).
- Current Australian serving Defense personnel or any member of the US military
currently serving on active duty.
- Participants involved with ongoing insurance or workplace claims that in the opinion
of the Investigator are likely to have an impact on the mental health, presentation or
capacity of the patient to engage in the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/06/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/07/2018
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Sample size
Target
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Accrual to date
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Final
193
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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- Penrith
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Recruitment hospital [2]
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- Auchenflower
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Recruitment hospital [3]
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- Toowong
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Recruitment hospital [4]
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- Elizabeth Vale
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Recruitment hospital [5]
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- St Kilda
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Recruitment postcode(s) [1]
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2751 - Penrith
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Recruitment postcode(s) [2]
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4066 - Auchenflower
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Recruitment postcode(s) [3]
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4066 - Toowong
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Recruitment postcode(s) [4]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [5]
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3004 - St Kilda
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Illinois
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Country [4]
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United States of America
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State/province [4]
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Kansas
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Country [5]
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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Nebraska
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Country [7]
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United States of America
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State/province [7]
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Nevada
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Country [8]
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United States of America
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State/province [8]
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New Jersey
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Country [9]
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United States of America
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State/province [9]
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Ohio
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Country [10]
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United States of America
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State/province [10]
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Tennessee
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Country [11]
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United States of America
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State/province [11]
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Texas
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bionomics Limited
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a randomized, double-blind, placebo-controlled study, evaluating the effects of
BNC210 versus placebo on the symptoms of Post-Traumatic Stress Disorder, as measured by the
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
The secondary objectives of the study are to evaluate the effects of BNC210 on anxiety,
depression, global functioning and patient reported outcomes in patients with PTSD. Safety
and tolerability of BNC210 will also be assessed. Study participants will receive 12 weeks of
blinded treatment followed by a 3 week follow-up period.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02933606
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02933606
Download to PDF