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A Phase 2b Study of BNC210 Tablet Formulation in Adults With Post-Traumatic Stress Disorder (PTSD) (ATTUNE)

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ClinicalTrials.gov Identifier: NCT04951076
Recruitment Status : Completed
First Posted : July 6, 2021
Last Update Posted : August 21, 2023
Sponsor:
Information provided by (Responsible Party):
Bionomics Limited

Study Description
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Brief Summary:
The purpose of this study is to assess the effects of BNC210 compared to placebo on PTSD symptom severity as measured by CAPS-5 Total Symptom Severity Scores.

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

Detailed Description:
This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study with a 12 week, 2-arm treatment period. Participants will attend a Screening visit within 3 weeks before randomization to confirm eligibility. Approximately 200 participants will be randomized using a 1:1 ratio to receive either BNC210 900 mg twice daily (b.i.d.) or matched placebo. Participants will then complete 12 weeks of treatment with their allocated study intervention. Participants will return to their study site at 4-weekly intervals to receive study intervention and complete safety and efficacy assessments. Participants are then requested to attend a Follow-up visit at Week 15 (i.e., 3 weeks after their last study intervention is administered).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double Blind, Two Arm Study to Investigate the Effects of BNC210 Tablet Formulation Compared to Placebo in Adults With Post-Traumatic Stress Disorder (PTSD)
Actual Study Start Date : July 27, 2021
Actual Primary Completion Date : July 25, 2023
Actual Study Completion Date : August 14, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: BNC210 Drug: BNC210
BNC210 900 mg twice daily (b.i.d.) for 12 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo twice daily (b.i.d.) for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: 12 weeks ]
    Change from Baseline on Investigator-rated symptoms of PTSD (total symptom severity scores)


Secondary Outcome Measures :
  1. Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: 12 Weeks ]
    Change from Baseline on Investigator-rated symptom clusters of PTSD (symptom cluster scores)

  2. Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: 12 weeks ]
    Response rate and remission rate using Investigator-rated symptoms of PTSD (total symptom severity scores)

  3. PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: 12 weeks ]
    Change from Baseline on patient-reported symptoms of PTSD

  4. Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 Weeks ]
    Change from Baseline on Investigator-rated symptoms of depression

  5. Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: 12 Weeks ]
    Change from Baseline on Investigator-rated symptoms of anxiety

  6. Clinician Global Impression (CGI) [ Time Frame: 12 weeks ]
    Change from Baseline on Investigator-rated global functioning

  7. Patient Global Impression (PGI) [ Time Frame: 12 weeks ]
    Change from Baseline on patient-reported global functioning

  8. Insomnia Severity Index (ISI) [ Time Frame: 12 weeks ]
    Change from Baseline on patient-reported sleep quality

  9. Sheehan Disability Scale (SDS) [ Time Frame: 12 weeks ]
    Change from Baseline on patient-reported social functioning


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with a current diagnosis of PTSD as defined by the CAPS-5 for DSM-5, with a CAPS-5 Total Symptom Severity Score of ≥30 at Screening and Baseline and no >25% decrease in Score from Screening to Baseline
  • The index trauma event must have occurred in adulthood, i.e., when the participant was ≥18 years of age
  • Suitable contraception use in line with protocol requirements
  • Ability to swallow tablets

Exclusion Criteria:

  • A period of less than 6 months since the index trauma event
  • Current and ongoing exposure to the trauma that caused the PTSD
  • Complex PTSD
  • Severe depression as measured by a score of ≥ 35 on the MADRS
  • Borderline personality disorder, bipolar disorder and other psychotic disorders
  • Use of antidepressant medications within 30 days (fluoxetine within 90 days) of Screening. The use of alprazolam, flunitrazepam and chronic daily use of other benzodiazepines within 90 day of Screening.
  • Failed more than three trials of antidepressant medication(s) prescribed for the treatment of PTSD.
  • Concurrent trauma-based psychotherapy such as Cognitive Behavior Therapy, Prolonged Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy. Participants may however continue to receive supportive counseling that has been in place for a minimum of three months prior to Screening.
  • Any moderate or severe substance use disorder in the past 12 months
  • Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04951076


Locations
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United States, California
ATTUNE Study Clinical Trial Site
Bellflower, California, United States, 90706
ATTUNE Study Clinical Trial Site
Beverly Hills, California, United States, 90210
ATTUNE Study Clinical Trial Site
Colton, California, United States, 92324
ATTUNE Study Clinical Trial Site
Oceanside, California, United States, 92056
ATTUNE Study Clinical Trial Site
Orange, California, United States, 92868
ATTUNE Study Clinical Trial Site
Temecula, California, United States, 92591
United States, Florida
ATTTUNE Study Clinical Trial Site
Jacksonville, Florida, United States, 32256
ATTUNE Study Clinical Trial Site
Lauderhill, Florida, United States, 33319
ATTUNE Study Clinical Trial Site
Miami Lakes, Florida, United States, 33016
ATTUNE Study Clinical Trial Site
Orlando, Florida, United States, 32801
United States, Kansas
ATTUNE Study Clinical Trial Site
Overland Park, Kansas, United States, 66221
ATTUNE Study Clinical Trial Site
Prairie Village, Kansas, United States, 66208
United States, Massachusetts
ATTUNE Study Clinical Trial Site
New Bedford, Massachusetts, United States, 02740
United States, Nevada
ATTUNE Study Clinical Trial Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
ATTUNE Study Clinical Trial Site
Berlin, New Jersey, United States, 08009
ATTUNE Study Clinical Trial Site
Cherry Hill, New Jersey, United States, 08002
United States, New York
ATTUNE Study Clinical Trial Site
Cedarhurst, New York, United States, 11516
ATTUNE Study Clinical Trial Site
Staten Island, New York, United States, 10312
United States, Ohio
ATTUNE Study Clinical Trial Site
North Canton, Ohio, United States, 44720
United States, Oklahoma
ATTUNE Study Clinical Trial Site
Oklahoma City, Oklahoma, United States, 73106
United States, Pennsylvania
ATTUNE Study Clinical Trial Site
West Chester, Pennsylvania, United States, 19380
United States, Tennessee
ATTUNE Study Clinical Trial Site
Memphis, Tennessee, United States, 38119
United States, Texas
ATTUNE Study Clinical Trial Site
Austin, Texas, United States, 78737
ATTUNE Study Clinical Trial Site
Dallas, Texas, United States, 75231
United States, Utah
ATTUNE Study Clinical Trial Site
Draper, Utah, United States, 84020
United Kingdom
ATTUNE Study Clinical Trial Site
Barnsley, United Kingdom, S75 3DL
ATTUNE Study Clinical Trial Site
Blackpool, United Kingdom, FY2 0JH
ATTUNE Study Clinical Trial Site
Cannock, United Kingdom, WS11 0BN
ATTUNE Study Clinical Trial Site
Leeds, United Kingdom, LS10 1DU
ATTUNE Study Clinical Trial Site
Liverpool, United Kingdom, L34 1BH
ATTUNE Study Clinical Trial Site
Manchester, United Kingdom, M13 9NQ
ATTUNE Study Clinical Trial Site
Stockton-on-Tees, United Kingdom, TS17 6EW
Sponsors and Collaborators
Bionomics Limited
More Information
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Responsible Party: Bionomics Limited
ClinicalTrials.gov Identifier: NCT04951076    
Other Study ID Numbers: BNC210.012
First Posted: July 6, 2021    Key Record Dates
Last Update Posted: August 21, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders