Post-Traumatic Stress DisorderPhase 2RESTORENCT02933606
Phase II Study of BNC210 in PTSD
A Phase 2 study testing BNC210 in people with Post-Traumatic Stress Disorder, run by Bionomics Limited at 25 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- BNC210
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 193 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 30 Jun 2016to 25 Jul 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States20 sites
Study site
Berlin, New Jersey, 08009
Study site
Canton, Ohio, 44718
Study site
Dallas, Texas, 75231
Study site
Gainesville, Florida, 32607
Study site
Hoffman Estates, Illinois, 60169
Study site
Jacksonville, Florida, 32256
Study site
Las Vegas, Nevada, 89102
Study site
Lauderhill, Florida, 33309
Study site
Lincoln, Nebraska, 68526
Study site
Memphis, Tennessee, 38119
Study site
New Bedford, Massachusetts, 02740
Study site
North Miami, Florida, 33161
Study site
Oakland Park, Florida, 33334
Study site
Oceanside, California, 92056
Study site
Orlando, Florida, 32801
Study site
Overland Park, Kansas, 66211
Study site
Rancho Mirage, California, 92270
Study site
Redlands, California, 92374
Study site
Riverside, California, 92506
Study site
San Antonio, Texas, 78229
Australia5 sites
Study site
Auchenflower, Queensland, 4066
Study site
Elizabeth Vale, South Australia, 5112
Study site
Penrith, New South Wales, 2751
Study site
St Kilda, Victoria, 3004
Study site
Toowong, Queensland, 4066
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Study of BNC210 in Adults With Post-Traumatic Stress Disorder (PTSD).
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.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- BNC210, Placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNC210Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BNC210 600 mg b.i.d. | Experimental | Suspension administered orally for 12 weeks. Receives: Drug: BNC210 |
| BNC210 300 mg b.i.d. | Experimental | Suspension administered orally for 12 weeks. Receives: Drug: BNC210 |
| BNC210 150 mg b.i.d. | Experimental | Suspension administered orally for 12 weeks. Receives: Drug: BNC210 |
| Placebo b.i.d. | Placebo comparator | Suspension administered orally for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5), Total Symptom Severity Score
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.
Measured: 12 weeks.
Secondary outcomes (11)
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.
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.
Measured: 12 weeks.
Montgomery- Åsberg Depression Rating Scale (MADRS).
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.
Measured: 12 weeks.
Hamilton Anxiety Rating Scale (HAM-A).
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.
Measured: 12 weeks
Clinical Global Impressions - Severity Scale (CGI-S).
Clinician's assessment of global symptom severity using the Clinical Global Impressions - Severity Scale (CGI-S).
Measured: 12 weeks
Clinical Global Impressions - Improvement Scale (CGI-I).
Clinician's assessment of global symptom improvement using the Clinical Global Impressions - Improvement Scale (CGI-I).
Measured: 12 weeks
Patient Global Impressions - Severity Scale (PGI-S).
Self-reported global symptom severity using the Patient Global Impressions - Severity Scale (CGI-S).
Measured: 12 weeks.
Patient Global Impression - Improvement Scale (PGI-I).
Self-reported global symptom improvement using the Patient Global Impression - Improvement Scale (PGI-I).
Measured: 12 weeks.
Assessment of Quality of Life (AQoL-8D).
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.
Measured: 12 weeks.
Social Functioning: Sheehan Disability Scale (SDS).
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.
Measured: 12 weeks.
Sleep Monitoring: Pittsburgh Sleep Quality Index (PSQI).
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
Measured: 12 weeks.
CANTAB (Cambridge Neuropsychological Test Automated Battery) Cognitive Assessment
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
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study start30 Jun 2016
- Primary completion5 Jul 2018
- Study completion25 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionomics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933606
- Sponsor's protocol ID
- BNC210.007
- Acronym
- RESTORE
- Status last verified
- Feb 2023
- First submitted
- 1 Sep 2016
- Last updated
- 27 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase II Study of BNC210 in Adults With Post-Traumatic Stress Disorder (PTSD).
- ClinicalTrials.gov ID
- NCT02933606
- Acronym / sponsor ID
- RESTORE / BNC210.007
- Conditions
- Post-Traumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Bionomics LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 5 Jul 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Posted 27 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BNC210 600 mg b.i.d. | Experimental | Drug: BNC210Suspension administered orally for 12 weeks. |
| BNC210 300 mg b.i.d. | Experimental | Drug: BNC210Suspension administered orally for 12 weeks. |
| BNC210 150 mg b.i.d. | Experimental | Drug: BNC210Suspension administered orally for 12 weeks. |
| Placebo b.i.d. | Placebo comparator | Drug: PlaceboSuspension administered orally for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNC210 | Drug | BNC210 150 mg b.i.d., BNC210 300 mg b.i.d., BNC210 600 mg b.i.d. |
| Placebo | Drug | Placebo b.i.d. |
Primary outcome
Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5), Total Symptom Severity Score
Time frame: 12 weeks.
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.
11 secondary outcomes
Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5).
Time frame: 12 weeks.
Montgomery- Åsberg Depression Rating Scale (MADRS).
Time frame: 12 weeks.
Hamilton Anxiety Rating Scale (HAM-A).
Time frame: 12 weeks
Clinical Global Impressions - Severity Scale (CGI-S).
Time frame: 12 weeks
Clinical Global Impressions - Improvement Scale (CGI-I).
Time frame: 12 weeks
Patient Global Impressions - Severity Scale (PGI-S).
Time frame: 12 weeks.
Patient Global Impression - Improvement Scale (PGI-I).
Time frame: 12 weeks.
Assessment of Quality of Life (AQoL-8D).
Time frame: 12 weeks.
Social Functioning: Sheehan Disability Scale (SDS).
Time frame: 12 weeks.
Sleep Monitoring: Pittsburgh Sleep Quality Index (PSQI).
Time frame: 12 weeks.
CANTAB (Cambridge Neuropsychological Test Automated Battery) Cognitive Assessment
Time frame: 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BNC210 in people with Post-Traumatic Stress Disorder, run by Bionomics Limited at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5), Total Symptom Severity Score (time frame: 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.