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CompletedNCT02933606RESTOREUpdated Feb 27, 2023Results posted

Phase II Study of BNC210 in PTSD

A Phase 2 interventional study of BNC210 and Placebo in Post-Traumatic Stress Disorder, sponsored by Bionomics Limited. Completed at 25 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-02-27.

Sponsored by Bionomics Limited · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
193
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Stress Disorders, Traumatic

1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

This study's enrollment of 193 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.

Browse Stress Disorders, Traumatic studies →

Lead sponsor

Bionomics Limited is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
193 participants (actual)

Study arms

  • 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

Interventions

  • DrugBNC210
  • DrugPlacebo
06

What researchers measure

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.

    Time frame: 12 weeks.

Secondary outcomes

  1. Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5).

    Self-reported PTSD symptom severity. The range for the Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5) Symptom Severity Score is 0-80, with a higher score meaning a higher severity of disease.

    Time frame: 12 weeks.

  2. Montgomery- Åsberg Depression Rating Scale (MADRS).

    Depression severity. The range for the Montgomery- Åsberg Depression Rating Scale (MADRS) is 0-60, with a higher score meaning a higher severity of disease.

    Time frame: 12 weeks.

  3. Hamilton Anxiety Rating Scale (HAM-A).

    Anxiety severity. The range for the Hamilton Anxiety Rating Scale (HAM-A) is 0-56, with a higher score meaning a higher severity of disease.

    Time frame: 12 weeks

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

    Clinician's assessment of global symptom severity using the Clinical Global Impressions - Severity Scale (CGI-S).

    Time frame: 12 weeks

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

    Clinician's assessment of global symptom improvement using the Clinical Global Impressions - Improvement Scale (CGI-I).

    Time frame: 12 weeks

  6. Patient Global Impressions - Severity Scale (PGI-S).

    Self-reported global symptom severity using the Patient Global Impressions - Severity Scale (CGI-S).

    Time frame: 12 weeks.

  7. Patient Global Impression - Improvement Scale (PGI-I).

    Self-reported global symptom improvement using the Patient Global Impression - Improvement Scale (PGI-I).

    Time frame: 12 weeks.

  8. Assessment of Quality of Life (AQoL-8D).

    Quality of Life. The range for the Assessment of Quality of Life (AQoL-8D) score is 35-176, with a higher score meaning a lower quality of life.

    Time frame: 12 weeks.

  9. Social Functioning: Sheehan Disability Scale (SDS).

    Social functioning. The range for the Total Score on the Sheehan Disability Scale (SDS) is 0-30, with a higher score meaning a higher degree of impairment.

    Time frame: 12 weeks.

  10. Sleep Monitoring: Pittsburgh Sleep Quality Index (PSQI).

    Sleep quality and duration. The range for the Pittsburgh Sleep Quality Index (PSQI) score is 0-21, with a higher score meaning a worse level of sleep quality

    Time frame: 12 weeks.

  11. CANTAB (Cambridge Neuropsychological Test Automated Battery) Cognitive Assessment

    The CANTAB global composite score is based on the Z scores for CANTAB outcome measures (PAL first attempt memory score (PALFAMS), PAL total errors adjusted (PALTEA), SWM between errors (SWMBE), SWM strategy (SWMS), RVP A' prime (RVPA), RVP median latency (RVPMDL). Specifically, the global composite score of cognitive function is as follows: CANTAB global composite score of cognitive function = (ZPALFAMS + ZPALTEA + ZSWMBE + ZSWMS + ZRVPA + ZRVPMDL) /8 (higher is better) A Z-score of 0 represents the population mean. A Z-score above 0 indicates cognition higher than the population mean and Z-score below 0 indicates cognition lower than the population mean

    Time frame: 12 Weeks

07

Results

Posted Feb 27, 2023
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.

Participant flow

Participant flow — Overall Study
MilestoneBNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.
Started49484749
Completed33393330
Not completed1691419

Outcome measures

PrimaryClinician-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.

Time frame:
12 weeks.
Reported as:
Least squares mean · score on a scale
Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5), Total Symptom Severity Score
score on a scaleBNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.
Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5), Total Symptom Severity Score15.26 (11.2 to 19.3)16.62 (12.3 to 20.9)19.76 (15.5 to 24.0)14.57 (9.8 to 19.4)
SecondaryPost-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5).

Self-reported PTSD symptom severity. The range for the Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5) Symptom Severity Score is 0-80, with a higher score meaning a higher severity of disease.

Time frame:
12 weeks.
Reported as:
Least squares mean · score on a scale
Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5).
score on a scaleBNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.
Post-Traumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5).25.02 (19.1 to 31.0)20.99 (15.3 to 26.7)29.97 (23.5 to 36.4)24.65 (17.8 to 31.5)
SecondaryMontgomery- Åsberg Depression Rating Scale (MADRS).

Depression severity. The range for the Montgomery- Åsberg Depression Rating Scale (MADRS) is 0-60, with a higher score meaning a higher severity of disease.

Time frame:
12 weeks.
Reported as:
Least squares mean · score on a scale
Montgomery- Åsberg Depression Rating Scale (MADRS).
score on a scaleBNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.
Montgomery- Åsberg Depression Rating Scale (MADRS).9.48 (6.7 to 12.3)10.25 (7.7 to 12.8)12.16 (9.4 to 14.9)8.94 (6.1 to 11.8)
SecondaryHamilton Anxiety Rating Scale (HAM-A).

Anxiety severity. The range for the Hamilton Anxiety Rating Scale (HAM-A) is 0-56, with a higher score meaning a higher severity of disease.

Time frame:
12 weeks
Reported as:
Least squares mean · score on a scale
Hamilton Anxiety Rating Scale (HAM-A).
score on a scaleBNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.
Hamilton Anxiety Rating Scale (HAM-A).9.03 (6.6 to 11.5)9.94 (7.6 to 12.3)10.55 (8.1 to 13.0)7.94 (5.3 to 10.6)
SecondaryClinical Global Impressions - Severity Scale (CGI-S).

Clinician's assessment of global symptom severity using the Clinical Global Impressions - Severity Scale (CGI-S).

Time frame:
12 weeks
Reported as:
Count of participants · Participants
Clinical Global Impressions - Severity Scale (CGI-S).
ParticipantsBNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.
Normal, not at all ill105510
Borderline mentally ill5366
Mildly ill81685
Moderately ill91397
Markedly ill1231
Severely ill0021
Among the most extremely ill patients0000
SecondaryClinical Global Impressions - Improvement Scale (CGI-I).

Clinician's assessment of global symptom improvement using the Clinical Global Impressions - Improvement Scale (CGI-I).

Time frame:
12 weeks
Reported as:
Count of participants · Participants
Clinical Global Impressions - Improvement Scale (CGI-I).
ParticipantsBNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.
Very Much Improved/Much Improved22231519
Other11161811
SecondaryPatient Global Impressions - Severity Scale (PGI-S).

Self-reported global symptom severity using the Patient Global Impressions - Severity Scale (CGI-S).

Time frame:
12 weeks.
Reported as:
Count of participants · Participants
Patient Global Impressions - Severity Scale (PGI-S).
ParticipantsBNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.
Normal116610
Mild8211413
Moderate121193
Severe2144
SecondaryPatient Global Impression - Improvement Scale (PGI-I).

Self-reported global symptom improvement using the Patient Global Impression - Improvement Scale (PGI-I).

Time frame:
12 weeks.
Reported as:
Count of participants · Participants
Patient Global Impression - Improvement Scale (PGI-I).
ParticipantsBNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.
Very Much/Much Improved17201820
Other16191510
SecondaryAssessment of Quality of Life (AQoL-8D).

Quality of Life. The range for the Assessment of Quality of Life (AQoL-8D) score is 35-176, with a higher score meaning a lower quality of life.

Time frame:
12 weeks.
Reported as:
Least squares mean · score on a scale
Assessment of Quality of Life (AQoL-8D).
score on a scaleBNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.
Assessment of Quality of Life (AQoL-8D).77.95 (71.4 to 84.5)76.79 (70.3 to 83.3)85.47 (78.0 to 93.0)81.05 (73.3 to 88.9)
SecondarySocial Functioning: Sheehan Disability Scale (SDS).

Social functioning. The range for the Total Score on the Sheehan Disability Scale (SDS) is 0-30, with a higher score meaning a higher degree of impairment.

Time frame:
12 weeks.
Reported as:
Least squares mean · score on a scale
Social Functioning: Sheehan Disability Scale (SDS).
score on a scaleBNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.
Social Functioning: Sheehan Disability Scale (SDS).8.84 (6.2 to 11.5)6.66 (4.0 to 9.3)10.32 (7.5 to 13.1)8.47 (5.3 to 11.7)
SecondarySleep Monitoring: Pittsburgh Sleep Quality Index (PSQI).

Sleep quality and duration. The range for the Pittsburgh Sleep Quality Index (PSQI) score is 0-21, with a higher score meaning a worse level of sleep quality

Time frame:
12 weeks.
Reported as:
Least squares mean · score on a scale
Sleep Monitoring: Pittsburgh Sleep Quality Index (PSQI).
score on a scaleBNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.
Sleep Monitoring: Pittsburgh Sleep Quality Index (PSQI).8.80 (7.5 to 10.1)8.83 (7.6 to 10.1)9.15 (7.7 to 10.6)8.00 (6.4 to 9.6)
SecondaryCANTAB (Cambridge Neuropsychological Test Automated Battery) Cognitive Assessment

The CANTAB global composite score is based on the Z scores for CANTAB outcome measures (PAL first attempt memory score (PALFAMS), PAL total errors adjusted (PALTEA), SWM between errors (SWMBE), SWM strategy (SWMS), RVP A' prime (RVPA), RVP median latency (RVPMDL). Specifically, the global composite score of cognitive function is as follows: CANTAB global composite score of cognitive function = (ZPALFAMS + ZPALTEA + ZSWMBE + ZSWMS + ZRVPA + ZRVPMDL) /8 (higher is better) A Z-score of 0 represents the population mean. A Z-score above 0 indicates cognition higher than the population mean and Z-score below 0 indicates cognition lower than the population mean

Time frame:
12 Weeks
Reported as:
Least squares mean · Composite Z score
CANTAB (Cambridge Neuropsychological Test Automated Battery) Cognitive Assessment
Composite Z scoreBNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.
CANTAB (Cambridge Neuropsychological Test Automated Battery) Cognitive Assessment0.06 (-0.1 to 0.2)0.12 (0.0 to 0.2)0.18 (0.1 to 0.3)0.02 (-0.1 to 0.2)

Adverse events

Collected over 15 Weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BNC210 600 mg b.i.d.0/48 (0%)0/48 (0%)31/48 (64.6%)
BNC210 300 mg b.i.d.0/48 (0%)1/48 (2.1%)42/48 (87.5%)
BNC210 150 mg b.i.d.0/47 (0%)0/47 (0%)30/47 (63.8%)
Placebo b.i.d.0/49 (0%)1/49 (2%)45/49 (91.8%)
Most frequent serious events
Most frequent serious events
EventBNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.
Elevated Liver Function TestsInvestigations0/481/480/470/49
Acute AbdomenGastrointestinal disorders0/480/480/471/49
Most frequent other events
Showing 10 of 13
Most frequent other events
EventBNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.
HeadacheNervous system disorders3/4810/484/4712/49
Upper Respiratory Tract InfectionInfections and infestations4/483/486/472/49
DiarrhoeaGastrointestinal disorders4/486/484/476/49
NauseaGastrointestinal disorders4/484/482/476/49
FatigueGeneral disorders2/485/482/471/49
NasopharyngitisInfections and infestations4/482/481/471/49
DizzinessNervous system disorders2/483/481/474/49
Dry MouthGastrointestinal disorders3/480/483/473/49
SomnolenceNervous system disorders3/483/482/471/49
Viral InfectionInfections and infestations1/483/482/470/49

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)BNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.Total
<=18 years10102
Between 18 and 65 years46484649189
>=65 years10001
Sex: Female, Male
Sex: Female, Male(Participants)BNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.Total
Female25263130112
Male2322161980
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.Total
American Indian or Alaska Native00000
Asian00000
Native Hawaiian or Other Pacific Islander00112
Black or African American161181045
White30353634135
More than one race11237
Unknown or Not Reported11013
Region of Enrollment
Region of Enrollment(participants)BNC210 600 mg b.i.d.BNC210 300 mg b.i.d.BNC210 150 mg b.i.d.Placebo b.i.d.Total
United States41414138161
Australia7761131
08

Study locations

25 sites
  • Oceanside, California 92056, United States
  • Rancho Mirage, California 92270, United States
  • Redlands, California 92374, United States
  • Riverside, California 92506, United States
  • Gainesville, Florida 32607, United States
  • Jacksonville, Florida 32256, United States
  • Lauderhill, Florida 33309, United States
  • North Miami, Florida 33161, United States
  • Oakland Park, Florida 33334, United States
  • Orlando, Florida 32801, United States
  • Hoffman Estates, Illinois 60169, United States
  • Overland Park, Kansas 66211, United States
  • New Bedford, Massachusetts 02740, United States
  • Lincoln, Nebraska 68526, United States
  • Las Vegas, Nevada 89102, United States
  • Berlin, New Jersey 08009, United States
  • Canton, Ohio 44718, United States
  • Memphis, Tennessee 38119, United States
  • Dallas, Texas 75231, United States
  • San Antonio, Texas 78229, United States
  • Penrith, New South Wales 2751, Australia
  • Auchenflower, Queensland 4066, Australia
  • Toowong, Queensland 4066, Australia
  • Elizabeth Vale, South Australia 5112, Australia
  • St Kilda, Victoria 3004, Australia
09

References and documents

Study documents

  • Study protocol · May 30, 2018
  • Statistical analysis plan · Sep 27, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02933606
Lead sponsor
Bionomics Limited
Responsible party
Sponsor
First posted
Oct 14, 2016
Start date
Jun 30, 2016
Primary completion
Jul 5, 2018
Completion
Jul 25, 2018
Results posted
Feb 27, 2023
Last update
Feb 27, 2023

Oversight

FDA-regulated drug
Yes
View the source record on ClinicalTrials.gov ↗

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