Phase II Study of BNC210 in PTSD
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: BNC210; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blind
Enrollment: 193.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  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 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.