Phase II Study of BNC210 in PTSD

NCT02933606 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BNC210.007
• Study Type: interventional
• Target: 193
• Locations: 2 countries
• Sites: 25

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.

Conditions

Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  12 weeks.

• Montgomery- Åsberg Depression Rating Scale (MADRS).

  12 weeks.

• Hamilton Anxiety Rating Scale (HAM-A).

  12 weeks

• Clinical Global Impressions - Severity Scale (CGI-S).

  12 weeks

• Clinical Global Impressions - Improvement Scale (CGI-I).

  12 weeks

Study Arms (4)

BNC210 600 mg b.i.d.

EXPERIMENTAL

Suspension administered orally for 12 weeks.

Drug: BNC210

BNC210 300 mg b.i.d.

EXPERIMENTAL

Suspension administered orally for 12 weeks.

Drug: BNC210

BNC210 150 mg b.i.d.

EXPERIMENTAL

Suspension administered orally for 12 weeks.

Drug: BNC210

Placebo b.i.d.

PLACEBO COMPARATOR

Suspension administered orally for 12 weeks.

Drug: Placebo

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Bionomics Limited: lead

Study Sites (25)

Unknown Facility

Oceanside, California, 92056, United States

Location

Unknown Facility

Rancho Mirage, California, 92270, United States

Location

Unknown Facility

Redlands, California, 92374, United States

Location

Unknown Facility

Riverside, California, 92506, United States

Location

Unknown Facility

Gainesville, Florida, 32607, United States

Location

Unknown Facility

Jacksonville, Florida, 32256, United States

Location

Unknown Facility

Lauderhill, Florida, 33309, United States

Location

Unknown Facility

North Miami, Florida, 33161, United States

Location

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Oakland Park, Florida, 33334, United States

Location

Unknown Facility

Orlando, Florida, 32801, United States

Location

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Hoffman Estates, Illinois, 60169, United States

Location

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Overland Park, Kansas, 66211, United States

Location

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New Bedford, Massachusetts, 02740, United States

Location

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Lincoln, Nebraska, 68526, United States

Location

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Las Vegas, Nevada, 89102, United States

Location

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Berlin, New Jersey, 08009, United States

Location

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Canton, Ohio, 44718, United States

Location

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Memphis, Tennessee, 38119, United States

Location

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Dallas, Texas, 75231, United States

Location

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San Antonio, Texas, 78229, United States

Location

Unknown Facility

Penrith, New South Wales, 2751, Australia

Location

Unknown Facility

Auchenflower, Queensland, 4066, Australia

Location

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Toowong, Queensland, 4066, Australia

Location

Unknown Facility

Elizabeth Vale, South Australia, 5112, Australia

Location

Unknown Facility

St Kilda, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

BNC210 suspension that is dependent on concomitant food intake did not achieve expected exposure levels in the trial participants. However, a planned pharmacometrics analysis established a model of CAPS-5 scores versus plasma exposure and predicted a target exposure for future trials (O'Connor S., SOBP Conference Poster, 2019). A new tablet formulation is being evaluated in a second BNC210 Phase 2 PTSD trial (NCT04951076) and substantially higher exposures are expected in the participants.

Results Point of Contact

• Title: VP Clinical Development
• Organization: Bionomics Limited

BNC210clinicalstudies@bionomics.com.au

+61 8 8150 7400

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: October 14, 2016
• Study Start: June 30, 2016
• Primary Completion: July 5, 2018
• Study Completion: July 25, 2018
• Last Updated: February 27, 2023
• Results First Posted: February 27, 2023

Record last verified: 2023-02

Locations

AU (5); US (20)