Phase II Study of BNC210 in PTSD (RESTORE)

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. Identifier: NCT02933606
Recruitment Status : Completed
First Posted : October 14, 2016
Last Update Posted : October 4, 2018
Information provided by (Responsible Party):
Bionomics Limited

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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Drug: BNC210 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Phase II Study of BNC210 in Adults With Post-Traumatic Stress Disorder (PTSD).
Actual Study Start Date : June 30, 2016
Actual Primary Completion Date : July 5, 2018
Actual Study Completion Date : July 25, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BNC210 600 mg b.i.d.
Suspension administered orally for 12 weeks.
Drug: BNC210
Experimental: BNC210 300 mg b.i.d.
Suspension administered orally for 12 weeks.
Drug: BNC210
Experimental: BNC210 150 mg b.i.d.
Suspension administered orally for 12 weeks.
Drug: BNC210
Placebo Comparator: Placebo b.i.d.
Suspension administered orally for 12 weeks.
Drug: Placebo

Primary Outcome Measures :
  1. Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5). [ Time Frame: 12 weeks. ]
    Investigator-rated PTSD symptom severity.

Secondary Outcome Measures :
  1. 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. ]
    Self-reported PTSD symptom severity.

  2. Montgomery- Åsberg Depression Rating Scale (MADRS). [ Time Frame: 12 weeks. ]
    Depression severity.

  3. Hamilton Anxiety Rating Scale (HAM-A). [ Time Frame: 12 weeks ]
    Anxiety severity.

  4. Clinical Global Impressions - Severity and Improvement Scale (CGI-S/CGI-I). [ Time Frame: 12 weeks ]
    Global symptom severity and improvement.

  5. Patient Global Impression - Severity and Improvement Scale (PGI-S/PGI - I). [ Time Frame: 12 weeks. ]
    Self-reported global symptom severity and improvement.

  6. Assessment of Quality of Life (AQoL-8D). [ Time Frame: 12 weeks. ]
    Quality of Life.

  7. Social functioning: Sheehan Disability Scale (SDS). [ Time Frame: 12 weeks. ]
    Social functioning.

  8. Sleep monitoring: Pittsburgh Sleep Quality Index (PSQI). [ Time Frame: 12 weeks. ]
    Sleep quality and duration.

  9. Number of participants with abnormal and clinically significant laboratory results, ECG, physical examinations, vital signs and / or Adverse Events (AEs). [ Time Frame: 15 weeks ]
  10. Columbia Suicide Severity Rating Scale (C-SSRS). [ Time Frame: 15 weeks. ]
    Suicidal Ideation, suicidal behaviour, and non-suicidal self-injurious behaviour.

  11. Cognitive functioning: CANTAB [ Time Frame: 12 weeks. ]
    Spatial working memory, visual rapid information processing, paired associates learning.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02933606

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Sponsors and Collaborators
Bionomics Limited

Responsible Party: Bionomics Limited Identifier: NCT02933606     History of Changes
Other Study ID Numbers: BNC210.007
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders