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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02933606




Registration number
NCT02933606
Ethics application status
Date submitted
1/09/2016
Date registered
14/10/2016
Date last updated
10/03/2020

Titles & IDs
Public title
Phase II Study of BNC210 in PTSD
Scientific title
A Randomized, Double-blind, Placebo-controlled Phase II Study of BNC210 in Adults With Post-Traumatic Stress Disorder (PTSD).
Secondary ID [1] 0 0
BNC210.007
Universal Trial Number (UTN)
Trial acronym
RESTORE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-Traumatic Stress Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
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


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5). - Investigator-rated PTSD symptom severity.
Timepoint [1] 0 0
12 weeks.
Secondary outcome [1] 0 0
Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5). - Self-reported PTSD symptom severity.
Timepoint [1] 0 0
12 weeks.
Secondary outcome [2] 0 0
Montgomery- Åsberg Depression Rating Scale (MADRS). - Depression severity.
Timepoint [2] 0 0
12 weeks.
Secondary outcome [3] 0 0
Hamilton Anxiety Rating Scale (HAM-A). - Anxiety severity.
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Clinical Global Impressions - Severity and Improvement Scale (CGI-S/CGI-I). - Global symptom severity and improvement.
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Patient Global Impression - Severity and Improvement Scale (PGI-S/PGI - I). - Self-reported global symptom severity and improvement.
Timepoint [5] 0 0
12 weeks.
Secondary outcome [6] 0 0
Assessment of Quality of Life (AQoL-8D). - Quality of Life.
Timepoint [6] 0 0
12 weeks.
Secondary outcome [7] 0 0
Social functioning: Sheehan Disability Scale (SDS). - Social functioning.
Timepoint [7] 0 0
12 weeks.
Secondary outcome [8] 0 0
Sleep monitoring: Pittsburgh Sleep Quality Index (PSQI). - Sleep quality and duration.
Timepoint [8] 0 0
12 weeks.
Secondary outcome [9] 0 0
Number of participants with abnormal and clinically significant laboratory results, ECG, physical examinations, vital signs and / or Adverse Events (AEs).
Timepoint [9] 0 0
15 weeks
Secondary outcome [10] 0 0
Columbia Suicide Severity Rating Scale (C-SSRS). - Suicidal Ideation, suicidal behaviour, and non-suicidal self-injurious behaviour.
Timepoint [10] 0 0
15 weeks.
Secondary outcome [11] 0 0
Cognitive functioning: CANTAB - Spatial working memory, visual rapid information processing, paired associates learning.
Timepoint [11] 0 0
12 weeks.

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.

Key
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Penrith
Recruitment hospital [2] 0 0
- Auchenflower
Recruitment hospital [3] 0 0
- Toowong
Recruitment hospital [4] 0 0
- Elizabeth Vale
Recruitment hospital [5] 0 0
- St Kilda
Recruitment postcode(s) [1] 0 0
2751 - Penrith
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
4066 - Toowong
Recruitment postcode(s) [4] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [5] 0 0
3004 - St Kilda
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bionomics Limited
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02933606
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications