Trial · NCT04951076

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

NCT04951076, Phase 2, Completed, Bionomics Limited; results first posted 2025-02-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 2b Study of BNC210 Tablet Formulation in Adults With Post-Traumatic Stress Disorder (PTSD). Trials, record NCT04951076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04951076

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase 2b Study of BNC210 Tablet Formulation in Adults With Post-Traumatic Stress Disorder (PTSD)
NCT number: NCT04951076
Status: Completed
Phases: Phase 2
Enrollment: 212 participants, actual
Lead sponsor: Bionomics Limited
Conditions: Post-Traumatic Stress Disorder
Interventions: BNC210, Placebo
First posted: 2021-07-06
Last updated: 2025-02-06
Results first posted: 2025-02-06

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline on the Clinician Administered Post-Traumatic Stress Disorder (PTSD) Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks,12 weeks	The CAPS-5 is a 30-item structured interview used to diagnose PTSD and assess PTSD symptoms over the past month. Information about the frequency and intensity of each item is combined into a severity rating, and the CAPS-5 total symptom severity score is calculated by adding the severity scores for the 20 PTSD symptoms in the DSM-5. Scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
Secondary	Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion B Symptom Cluster Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	Criterion B (Intrusive Thoughts) is a 5-item sub section of the CAPS-5 scale that assesses intrusion symptoms associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 20, with higher scores indicating greater severity of intrusion symptoms.
Secondary	Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion C Symptom Cluster Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	Criterion C (Avoidance) is a 2-item sub section of the CAPS-5 scale that assesses avoidance of stimuli associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 8, with higher scores indicating greater severity of avoidance symptoms.
Secondary	Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion D Symptom Cluster Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	Criterion D (Negative Alterations in Cognitions and Mood) is a 7-item sub section of the CAPS-5 scale that assesses negative alterations in cognitions and mood associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 28, with higher scores indicating greater severity of negative alterations in cognitions and mood symptoms.
Secondary	Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion E Symptom Cluster Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	Criterion E (Arousal and Reactivity) is a 6-item sub section of the CAPS-5 scale that assesses marked alterations in arousal and reactivity associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 24, with higher scores indicating greater severity of arousal and reactivity symptoms.
Secondary	Change From Baseline on Montgomery Asberg Depression Rating Scale (MADRS) Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	The MADRS is a 10-item clinician-rated questionnaire to measure the presence and severity of depressive episodes. Each item is rated on a scale of 0 to 6. The score from each item is combined into a total score ranging from 0 to 60, with higher scores indicating greater severity of depressive episodes.
Secondary	Change From Baseline on Hamilton Anxiety Rating Scale (HAM-A) Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	The HAM-A is an interview questionnaire that measures severity of anxiety symptoms based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior during the interview. Each parameter is rated on a scale of 0 (not present) to 4 (very severe). The score from each parameter is combined into a total score. Scores range from 0 to 56, with higher scores indicating greater severity of anxiety symptoms.
Secondary	Change From Baseline on Clinician Global Impression - Severity (CGI-S) Scale Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	The CGI-S is a rating scale designed to assess the overall severity of the participant's symptoms. Severity is rated on a scale from 1 (normal, not at all ill) to 7 (among the most extremely ill of participants), with a higher score indicating greater severity of symptoms.
Secondary	Change From Baseline on Patient Global Impression - Severity (PGI-S) Scale Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	Change from Baseline on patient-reported global functioning The PGI-S is a patient self-reported counterpart of the CGI-S designed to assess the patient's impression of their perceived severity of overall symptoms.Severity is rated on the PGI-S from 1 (normal) to 6 (very severe), with a higher score indicating greater severity of symptoms.
Secondary	Change From Baseline on Insomnia Severity Index (ISI) Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	The ISI is a brief self-report instrument measuring both nocturnal and diurnal symptoms of insomnia. The ISI comprises seven items, each scored from 0 to 4. The scores from each of the 7 questions are added up to get a total score of 0 to 28, with a higher score indicating a higher level of symptom severity.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change From Baseline on the Clinician Administered Post-Traumatic Stress Disorder (PTSD) Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks,12 weeks	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion B Symptom Cluster Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion C Symptom Cluster Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion D Symptom Cluster Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion E Symptom Cluster Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline on Montgomery Asberg Depression Rating Scale (MADRS) Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline on Hamilton Anxiety Rating Scale (HAM-A) Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline on Clinician Global Impression - Severity (CGI-S) Scale Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline on Patient Global Impression - Severity (PGI-S) Scale Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline on Insomnia Severity Index (ISI) Scores After 12 Weeks	Baseline, 4 weeks, 8 weeks, 12 weeks	score on a scale	LEAST_SQUARES_MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline on the Clinician Administered Post-Traumatic Stress Disorder (PTSD) Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores After 12 Weeks	BNC210 900 mg	-20.08	Standard Error 1.717	score on a scale
Change From Baseline on the Clinician Administered Post-Traumatic Stress Disorder (PTSD) Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores After 12 Weeks	Placebo	-16.05	Standard Error 1.469	score on a scale
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion B Symptom Cluster Scores After 12 Weeks	BNC210 900 mg	-5.72	Standard Error 0.547	score on a scale
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion B Symptom Cluster Scores After 12 Weeks	Placebo	-4.40	Standard Error 0.472	score on a scale
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion C Symptom Cluster Scores After 12 Weeks	BNC210 900 mg	-2.28	Standard Error 0.299	score on a scale
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion C Symptom Cluster Scores After 12 Weeks	Placebo	-1.79	Standard Error 0.254	score on a scale
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion D Symptom Cluster Scores After 12 Weeks	BNC210 900 mg	-7.77	Standard Error 0.790	score on a scale
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion D Symptom Cluster Scores After 12 Weeks	Placebo	-5.98	Standard Error 0.678	score on a scale
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion E Symptom Cluster Scores After 12 Weeks	BNC210 900 mg	-4.35	Standard Error 0.514	score on a scale
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion E Symptom Cluster Scores After 12 Weeks	Placebo	-3.98	Standard Error 0.436	score on a scale

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	BNC210 900 mg	106
Overall Study	STARTED	Placebo	106
Overall Study	Received Any Trial Drug	BNC210 900 mg	105
Overall Study	Received Any Trial Drug	Placebo	104
Overall Study	Modified Intent-To-Treat (mITT)	BNC210 900 mg	89
Overall Study	Modified Intent-To-Treat (mITT)	Placebo	93
Overall Study	COMPLETED	BNC210 900 mg	57
Overall Study	COMPLETED	Placebo	66
Overall Study	NOT COMPLETED	BNC210 900 mg	49
Overall Study	NOT COMPLETED	Placebo	40

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	BNC210 900 mg	18	105
other	Headache	Nervous system disorders	Placebo	13	104
other	Nausea	Gastrointestinal disorders	BNC210 900 mg	13	105
other	Nausea	Gastrointestinal disorders	Placebo	8	104
other	Fatigue	General disorders	BNC210 900 mg	6	105
other	Fatigue	General disorders	Placebo	8	104
other	Eleveted Liver Enzymes	Investigations	BNC210 900 mg	14	105
other	Eleveted Liver Enzymes	Investigations	Placebo	2	104
serious	Cholelithiasis	Hepatobiliary disorders	BNC210 900 mg	0	105	0
serious	Cholelithiasis	Hepatobiliary disorders	Placebo	1	104	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BNC210 900 mg	0	105
Total, all-cause mortality	Placebo	0	104
Total, other adverse events	BNC210 900 mg	36	105
Total, other adverse events	Placebo	25	104
Total, serious adverse events	BNC210 900 mg	0	105
Total, serious adverse events	Placebo	2	104

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39647171	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
BNC210 900 mg vs Placebo: deaths from any cause	Trial comparisons
BNC210 900 mg vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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