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TerminatedNCT05665088Updated Oct 1, 2026Results posted

Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)

A Phase 3 interventional study of BXCL501 and Matching Placebo in Agitation and Dementia, sponsored by BioXcel Therapeutics Inc. Terminated at 7 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by BioXcel Therapeutics Inc · Phase 3, Interventional, and Treatment

Why this study was terminated
Study was terminated for business reasons; not due to safety or efficacy concerns
Updated Oct 1, 2026Results postedStart date moved+3 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

A study to determine the safety and efficacy of BXCL501 dosing for episodes of agitation associated with dementia when they occur (given as needed [PRN]), for a maximum of 168 doses within a 12-week treatment period.

Read the detailed description

A randomized, double-blind, placebo-controlled, parallel group, 3-arm study assessing efficacy, safety, and tolerability of two doses of BXCL501 in male and female participants (65 years and older) with acute psychomotor agitation associated with dementia.

Approximately 150 participants will participate in this study. Participants will receive a single film consisting of BXCL501 40 micrograms (µg) dose or BXCL501 60 µg dose or placebo. Participants must reside in a care facility where all study-related procedures and study drug dosing will be performed.

02

Conditions studied

  • Agitation
  • Dementia
03

In context

Psychomotor Agitation

500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.

This study's enrollment of 13 is below the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.

Browse Psychomotor Agitation studies →

Lead sponsor

BioXcel Therapeutics Inc is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.

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

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. All participants must have a diagnosis of probable Alzheimer's disease (AD) based on National Institute on Aging and Alzheimer's Association (NIA-AA) criteria (2018). If participant biomarker data are unavailable, per the 2018 NIA-AA diagnostic criteria, the clinical diagnosis of probable AD will be based on the 2011 NIA-AA criteria
  2. Episodes of psychomotor agitation (e.g., kick, bite, flailing)
  3. Participants exhibit behaviors that are congruent with the International Psychogeriatric Association criterion for agitation representing a change from the participant's usual behavior
  4. A score of 0 to 20 on the Mini-Mental State Exam (MMSE) and require moderate to full assistance with activities of daily living
  5. Participants who read, understand, and provide written informed consent, or who have a legally authorized representative (LAR) to provide consent on their behalf
  6. Participants who are deemed to be medically appropriate for study participation by the principal investigator
  7. Participants who agree to use a medically acceptable and effective birth control method

Exclusion criteria

Exclusion Criteria:

  1. Participants with dementia or other memory impairment not due to probable AD.
  2. Clinical diagnosis of probable AD should not be applied when there is evidence of a cerebrovascular incident temporally related to the worsening of cognitive function.
  3. Participants with agitation caused by acute intoxication.
  4. Participants with significant risk of suicide or homicide per the investigator's assessment.
  5. Participants who are medically unstable or in recovery. Note: Participants with a remote (>5 years) history of stroke may be included, regardless of size/location.
  6. History of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years, current evidence of hypovolemia, orthostatic hypotension, bradycardia.
  7. Participants with laboratory or electrocardiogram (ECG) abnormalities.
  8. Participants who have received an investigational drug within 30 days prior to Screening.
  9. Participants who are currently suffering from substance abuse.
  10. Participants with a potential cause for delirium (relatively recent onset agitation and dementia)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    BXCL501: 40 μg

    Participants will receive 40 μg of BXCL501 sublingually or buccally, with up to 2 doses permitted per calendar day over the 12-week treatment period.

    Drug: BXCL501

  • Experimental
    BXCL501: 60 μg

    Participants will receive 60 μg of BXCL501 sublingually or buccally, with up to 2 doses permitted per calendar day over the 12-week treatment period.

    Drug: BXCL501

  • Placebo comparator
    Placebo

    Participants will receive placebo-matched to BXCL501 with up to 2 doses permitted per calendar day over the 12-week treatment period.

    Drug: Matching Placebo

Interventions

  • DrugBXCL501

    Solid-dose film administered sublingually or buccally

    Also known as: Dexmedetomidine

  • DrugMatching Placebo

    Matching solid-dose film administered sublingually or buccally

06

What researchers measure

Primary outcomes

  1. Change From Pre-dose in PEC Total Score at 30 Minutes Post-dose for the First Treated Episode of Agitation

    The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.

    Time frame: Pre-dose, 30 minutes post-dose

  2. Change From Pre-dose in PEC Total Score at 1 Hour Post-dose for the First Treated Episode of Agitation

    The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.

    Time frame: Pre-dose, 1 hour post-dose

  3. Change From Pre-dose in PEC Total Score at 2 Hours Post-dose for the First Treated Episode of Agitation

    The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.

    Time frame: Pre-dose, 2 hours post-dose

  4. Change From Pre-dose in PEC Total Score at 4 Hours Post-dose for the First Treated Episode of Agitation

    The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.

    Time frame: Pre-dose, 4 hours post-dose

  5. Change From Pre-dose in PEC Total Score at 8 Hours Post-dose for the First Treated Episode of Agitation

    The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.

    Time frame: Pre-dose, 8 hours post-dose

  6. Change From Pre-dose in PEC Total Score at 12 Hours Post-dose for the First Treated Episode of Agitation

    The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.

    Time frame: Pre-dose, 12 hours post-dose

  7. Change From Pre-dose in PEC Total Score at 24 Hours Post-dose for the First Treated Episode of Agitation

    The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.

    Time frame: Pre-dose, 24 hours post-dose

Secondary outcomes

  1. Change From Pre-dose in Pittsburgh Agitation Scale (PAS) Total Score at 2 Hours Post-dose for the First Episode of Agitation

    The PAS is an instrument based on direct observations of the participant that is developed to monitor the severity of agitation associated with dementia. The PAS is the sum of 4 behavior groups observed (aberrant vocalization, motor agitation, aggressiveness, resisting care, each behavior group ranging from 0 \[not present\] to 4 \[maximally present\]), and thus total score ranges from 0 (absence of agitation) to 16 (extremely severe). Lower score indicated better outcome.

    Time frame: Pre-dose, 2 hours post-dose

  2. Change From Pre-dose in Clinical Global Impression of Severity (CGI-S) Score at 2 Hours Post-dose for the First Episode of Agitation

    The CGI-S was used to rate the severity of agitation. The score ranges from 0 to 4 that comprises of, 0=not assessed; 1=normal, not at all symptomatic; 2=mildly symptomatic-low level of symptoms-little interference in social functioning; 3=moderately symptomatic-some prominent symptoms-some interference in functioning; 4=severely symptomatic- very marked symptoms make it difficult for participants to engage with others. Higher scores indicate greater severity of agitation.

    Time frame: Pre-dose, 2 hours post-dose

  3. Clinical Global Impression of Improvement (CGI-I) Score at 30 Minutes, 1 Hour, and 2 Hours Post-dose for the First Treated Episodes of Agitation

    The CGI-I is a global measure of improvement or change from baseline in participant's condition. The CGI-I score ranges from 0 to 7 that comprises of 0 = not assessed (missing), 1= very much improved, 2= much improved, 3= minimally improved, 4= no change, 5= minimally worse, 6= much worse, and 7= very much worse. Higher scores indicate worse condition.

    Time frame: 30 minutes, 1 hour, and 2 hours post-dose

  4. Change From Pre-dose in Agitation-Calmness Evaluation Scale (ACES) Scores at 1, 2, 4, and 8 Hours Post-dose for the First Episode of Agitation.

    The ACES is a single-item clinician-rated measure of agitation and sedation. Scores range from 1 to 9, where 1= marked agitation, 2= moderate agitation, 3= mild agitation, 4= normal behavior, 5= mild calmness, 6= moderate calmness, 7= marked calmness, 8= deep sleep, and 9= unarousable. Higher scores indicate greater levels of calmness and sedation.

    Time frame: Pre-dose, 1, 2 , 4 and 8 hours post-dose

  5. Number of Treated Episodes of Agitation After the First Treated Episode

    Time frame: Up to 12 weeks

07

Results

Posted Oct 1, 2026
Limitations and caveats
Study was terminated for business reasons; not due to safety or efficacy concerns.

Participant flow

The study was conducted in United States from 05-Dec-2022 to 11-Sep-2023.

Participant flow — Overall Study
MilestoneBXCL501: 40 μgBXCL501: 60 μgPlacebo
Started535
Completed435
Not completed100
Withdrew: Withdrawal by subject100

Outcome measures

PrimaryChange From Pre-dose in PEC Total Score at 30 Minutes Post-dose for the First Treated Episode of Agitation

The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.

Time frame:
Pre-dose, 30 minutes post-dose
Reported as:
Mean · score on a scale
Change From Pre-dose in PEC Total Score at 30 Minutes Post-dose for the First Treated Episode of Agitation
score on a scaleBXCL501: 40 μgBXCL501: 60 μgPlacebo
Change From Pre-dose in PEC Total Score at 30 Minutes Post-dose for the First Treated Episode of Agitation-4.2 ± 2.28-3.0 ± 0.00-6.8 ± 5.81
PrimaryChange From Pre-dose in PEC Total Score at 1 Hour Post-dose for the First Treated Episode of Agitation

The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.

Time frame:
Pre-dose, 1 hour post-dose
Reported as:
Mean · score on a scale
Change From Pre-dose in PEC Total Score at 1 Hour Post-dose for the First Treated Episode of Agitation
score on a scaleBXCL501: 40 μgBXCL501: 60 μgPlacebo
Change From Pre-dose in PEC Total Score at 1 Hour Post-dose for the First Treated Episode of Agitation-6.4 ± 2.07-5.7 ± 1.53-6.0 ± 5.79
PrimaryChange From Pre-dose in PEC Total Score at 2 Hours Post-dose for the First Treated Episode of Agitation

The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.

Time frame:
Pre-dose, 2 hours post-dose
Reported as:
Mean · score on a scale
Change From Pre-dose in PEC Total Score at 2 Hours Post-dose for the First Treated Episode of Agitation
score on a scaleBXCL501: 40 μgBXCL501: 60 μgPlacebo
Change From Pre-dose in PEC Total Score at 2 Hours Post-dose for the First Treated Episode of Agitation-4.4 ± 5.13-3.3 ± 3.51-5.2 ± 8.56
PrimaryChange From Pre-dose in PEC Total Score at 4 Hours Post-dose for the First Treated Episode of Agitation

The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.

Time frame:
Pre-dose, 4 hours post-dose
Reported as:
Mean · score on a scale
Change From Pre-dose in PEC Total Score at 4 Hours Post-dose for the First Treated Episode of Agitation
score on a scaleBXCL501: 40 μgBXCL501: 60 μgPlacebo
Change From Pre-dose in PEC Total Score at 4 Hours Post-dose for the First Treated Episode of Agitation-12.0-11.0-15.3 ± 2.31
PrimaryChange From Pre-dose in PEC Total Score at 8 Hours Post-dose for the First Treated Episode of Agitation

The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.

Time frame:
Pre-dose, 8 hours post-dose
Reported as:
Mean · score on a scale
Change From Pre-dose in PEC Total Score at 8 Hours Post-dose for the First Treated Episode of Agitation
score on a scaleBXCL501: 40 μgBXCL501: 60 μgPlacebo
Change From Pre-dose in PEC Total Score at 8 Hours Post-dose for the First Treated Episode of Agitation-20.0—-12.0
PrimaryChange From Pre-dose in PEC Total Score at 12 Hours Post-dose for the First Treated Episode of Agitation

The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.

Time frame:
Pre-dose, 12 hours post-dose

No measurements were reported for this outcome.

PrimaryChange From Pre-dose in PEC Total Score at 24 Hours Post-dose for the First Treated Episode of Agitation

The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.

Time frame:
Pre-dose, 24 hours post-dose
Reported as:
Mean · score on a scale
Change From Pre-dose in PEC Total Score at 24 Hours Post-dose for the First Treated Episode of Agitation
score on a scaleBXCL501: 40 μgBXCL501: 60 μgPlacebo
Change From Pre-dose in PEC Total Score at 24 Hours Post-dose for the First Treated Episode of Agitation-12.0-5.0-8.5 ± 7.78
SecondaryChange From Pre-dose in Pittsburgh Agitation Scale (PAS) Total Score at 2 Hours Post-dose for the First Episode of Agitation

The PAS is an instrument based on direct observations of the participant that is developed to monitor the severity of agitation associated with dementia. The PAS is the sum of 4 behavior groups observed (aberrant vocalization, motor agitation, aggressiveness, resisting care, each behavior group ranging from 0 \[not present\] to 4 \[maximally present\]), and thus total score ranges from 0 (absence of agitation) to 16 (extremely severe). Lower score indicated better outcome.

Time frame:
Pre-dose, 2 hours post-dose
Reported as:
Mean · score on a scale
Change From Pre-dose in Pittsburgh Agitation Scale (PAS) Total Score at 2 Hours Post-dose for the First Episode of Agitation
score on a scaleBXCL501: 40 μgBXCL501: 60 μgPlacebo
Change From Pre-dose in Pittsburgh Agitation Scale (PAS) Total Score at 2 Hours Post-dose for the First Episode of Agitation-3.2 ± 2.28-2.3 ± 1.15-3.0 ± 4.24
SecondaryChange From Pre-dose in Clinical Global Impression of Severity (CGI-S) Score at 2 Hours Post-dose for the First Episode of Agitation

The CGI-S was used to rate the severity of agitation. The score ranges from 0 to 4 that comprises of, 0=not assessed; 1=normal, not at all symptomatic; 2=mildly symptomatic-low level of symptoms-little interference in social functioning; 3=moderately symptomatic-some prominent symptoms-some interference in functioning; 4=severely symptomatic- very marked symptoms make it difficult for participants to engage with others. Higher scores indicate greater severity of agitation.

Time frame:
Pre-dose, 2 hours post-dose
Reported as:
Mean · score on a scale
Change From Pre-dose in Clinical Global Impression of Severity (CGI-S) Score at 2 Hours Post-dose for the First Episode of Agitation
score on a scaleBXCL501: 40 μgBXCL501: 60 μgPlacebo
Change From Pre-dose in Clinical Global Impression of Severity (CGI-S) Score at 2 Hours Post-dose for the First Episode of Agitation-0.8 ± 0.84-0.3 ± 0.58-0.6 ± 1.14
SecondaryClinical Global Impression of Improvement (CGI-I) Score at 30 Minutes, 1 Hour, and 2 Hours Post-dose for the First Treated Episodes of Agitation

The CGI-I is a global measure of improvement or change from baseline in participant's condition. The CGI-I score ranges from 0 to 7 that comprises of 0 = not assessed (missing), 1= very much improved, 2= much improved, 3= minimally improved, 4= no change, 5= minimally worse, 6= much worse, and 7= very much worse. Higher scores indicate worse condition.

Time frame:
30 minutes, 1 hour, and 2 hours post-dose
Reported as:
Mean · score on a scale
Clinical Global Impression of Improvement (CGI-I) Score at 30 Minutes, 1 Hour, and 2 Hours Post-dose for the First Treated Episodes of Agitation
score on a scaleBXCL501: 40 μgBXCL501: 60 μgPlacebo
30 min Post-dose2.6 ± 0.553.3 ± 0.582.2 ± 1.10
1 hour Post-dose2.0 ± 0.002.3 ± 0.582.6 ± 2.07
2 hours Post-dose2.8 ± 0.843.0 ± 1.003.0 ± 2.35
SecondaryChange From Pre-dose in Agitation-Calmness Evaluation Scale (ACES) Scores at 1, 2, 4, and 8 Hours Post-dose for the First Episode of Agitation.

The ACES is a single-item clinician-rated measure of agitation and sedation. Scores range from 1 to 9, where 1= marked agitation, 2= moderate agitation, 3= mild agitation, 4= normal behavior, 5= mild calmness, 6= moderate calmness, 7= marked calmness, 8= deep sleep, and 9= unarousable. Higher scores indicate greater levels of calmness and sedation.

Time frame:
Pre-dose, 1, 2 , 4 and 8 hours post-dose
Reported as:
Mean · score on a scale
Change From Pre-dose in Agitation-Calmness Evaluation Scale (ACES) Scores at 1, 2, 4, and 8 Hours Post-dose for the First Episode of Agitation.
score on a scaleBXCL501: 40 μgBXCL501: 60 μgPlacebo
Change at 1 hour Post-dose0.6 ± 0.550.7 ± 0.581.0 ± 1.22
Change at 2 hours Post-dose0.6 ± 0.890.3 ± 0.580.8 ± 1.48
Change at 4 hours Post-dose2.02.02.3 ± 0.58
Change at 8 hours Post-dose7.0—2.0
SecondaryNumber of Treated Episodes of Agitation After the First Treated Episode
Time frame:
Up to 12 weeks
Reported as:
Number · Number of agitation episodes
Number of Treated Episodes of Agitation After the First Treated Episode
Number of agitation episodesBXCL501: 40 μgBXCL501: 60 μgPlacebo
Number of Treated Episodes of Agitation After the First Treated Episode575859

Adverse events

Collected over From first dose of study drug up to 30 days after the last dose (maximum duration:16 weeks). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BXCL501: 40 μg0/5 (0%)0/5 (0%)2/5 (40%)
BXCL501: 60 μg0/3 (0%)1/3 (33.3%)3/3 (100%)
Placebo0/5 (0%)1/5 (20%)4/5 (80%)
Most frequent serious events
Most frequent serious events
EventBXCL501: 40 μgBXCL501: 60 μgPlacebo
AgitationPsychiatric disorders0/51/30/5
PneumoniaInfections and infestations0/50/31/5
Most frequent other events
Showing 10 of 16
Most frequent other events
EventBXCL501: 40 μgBXCL501: 60 μgPlacebo
BradycardiaCardiac disorders2/50/30/5
Gait disturbanceGeneral disorders0/51/30/5
OedemaGeneral disorders0/51/30/5
DysphoniaRespiratory, thoracic and mediastinal disorders0/51/30/5
FallInjury, poisoning and procedural complications0/50/31/5
Abdominal painGastrointestinal disorders0/50/31/5
Skin irritationSkin and subcutaneous tissue disorders0/50/31/5
DiarrhoeaGastrointestinal disorders0/50/31/5
Upper respiratory tract infectionInfections and infestations0/50/31/5
CellulitisInfections and infestations0/50/31/5

Baseline characteristics

Safety Population: All participants who received at least 1 dose of study drug, with participants classified according to the drug actually received.

Age, Continuous
Age, Continuous(years)BXCL501: 40 μgBXCL501: 60 μgPlaceboTotal
Mean84.6 ± 4.8389.3 ± 3.5182.4 ± 8.7384.8 ± 6.54
Sex: Female, Male
Sex: Female, Male(Participants)BXCL501: 40 μgBXCL501: 60 μgPlaceboTotal
Female4329
Male1034
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BXCL501: 40 μgBXCL501: 60 μgPlaceboTotal
Hispanic or Latino0101
Not Hispanic or Latino52512
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BXCL501: 40 μgBXCL501: 60 μgPlaceboTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White53513
More than one race0000
Unknown or Not Reported0000
Positive and Negative Syndrome Scale - Excited Component (PEC) Total Score at Pre-dose
Positive and Negative Syndrome Scale - Excited Component (PEC) Total Score at Pre-dose(score on a scale)BXCL501: 40 μgBXCL501: 60 μgPlaceboTotal
Mean19.4 ± 3.9123.0 ± 8.1920.6 ± 1.5220.7 ± 4.37
08

Study locations

7 sites
  • BioXcel Clinical Research Site
    Los Alamitos, California 90720, United States
  • BioXcel Clinical Research Site
    Daytona Beach, Florida 32117, United States
  • BioXcel Clinical Research Site
    Maitland, Florida 32751, United States
  • BioXcel Clinical Research Site
    The Villages, Florida 32162, United States
  • BioXcel Clinical Research Site
    Marrero, Louisiana 70072, United States
  • BioXcel Clinical Research Site
    Springfield, Massachusetts 01103, United States
  • BioXcel Clinical Research Site
    Toms River, New Jersey 08755, United States
09

References and documents

Study documents

  • Study protocol · Apr 10, 2023
  • Statistical analysis plan · Dec 6, 2023

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

Individual participant data

Plan to share: No

10

Updates

1 registry update since Sep 25, 2026
Results
Results posted
posted Oct 1, 2026
Start date
Dec 14, 2022→Dec 5, 2022
Oct 1, 2026
Also revised
eligibility, primary outcomes and interventions
Show all 1 update
  1. Oct 1, 2026
    Results posted
    Start date Dec 14, 2022→Dec 5, 2022
    Eligibility Criteria revised
    Primary outcomes Revised (8 changes)
    Interventions Arms or interventions changed
    + 7 other changes: index terms, identifiers, verification date, registry dates, description, secondary outcomes and documents

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT05665088
Lead sponsor
BioXcel Therapeutics Inc
Collaborators
Cognitive Research Corporation
Responsible party
Sponsor
First posted
Dec 27, 2022
Start date
Dec 5, 2022
Primary completion
Sep 11, 2023
Completion
Sep 11, 2023
Results posted
Oct 1, 2026
Last update
Oct 1, 2026

Study contacts

Robert Risinger, MD
study chair · BioXcel Therapeutics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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