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A Phase 2b Study of BNC210 Tablet Formulation in Adults With Post-Traumatic Stress Disorder (PTSD) (ATTUNE Trial)
Phase 2
Waitlist Available
Research Sponsored by Bionomics Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial is testing BNC210, a medication that may help reduce PTSD symptoms by balancing brain chemicals related to stress and anxiety. The study involves people with PTSD who will take either BNC210 or another substance for a few months. Researchers will compare the effects on PTSD symptoms between the participants.
Eligible Conditions
- Post Traumatic Stress Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Clinician Global Impression (CGI)
Hamilton Anxiety Rating Scale (HAM-A)
+5 moreSide effects data
From 2018 Phase 2 trial • 193 Patients • NCT029336068%
Upper Respiratory Tract Infection
8%
Diarrhoea
8%
Nausea
8%
Nasopharyngitis
6%
Headache
6%
Somnolence
6%
Dry Mouth
4%
Dizziness
4%
Fatigue
2%
Dyspepsia
2%
Viral Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
BNC210 600 mg b.i.d.
BNC210 300 mg b.i.d.
BNC210 150 mg b.i.d.
Placebo b.i.d.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BNC210Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BNC210
2016
Completed Phase 2
~450
Find a Location
Who is running the clinical trial?
Bionomics LimitedLead Sponsor
7 Previous Clinical Trials
890 Total Patients Enrolled