Trial Outcomes & Findings for An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia (NCT NCT05276830)

NCT ID: NCT05276830

Last Updated: 2023-08-25

Results Overview

The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 120 minutes
• Results posted on: 2023-08-25

Participant Flow

The study was conducted in United States from 08 February 2022 to 01 April 2022.

Participant milestones

Measure	BXCL501: 40 Micrograms Participants received a single sublingual film containing 40 micrograms Dexmedetomidine (BXCL501)	BXCL501: 60 Micrograms Participants received a single sublingual film containing 60 micrograms Dexmedetomidine (BXCL501)	Placebo Participants received a single sublingual matching placebo film
Overall Study STARTED	2	1	2
Overall Study COMPLETED	2	1	2
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia

Baseline characteristics by cohort

Measure	BXCL501: 40 Micrograms n=2 Participants Participants received a single sublingual film containing 40 micrograms Dexmedetomidine (BXCL501)	BXCL501: 60 Micrograms n=1 Participants Participants received a single sublingual film containing 60 micrograms Dexmedetomidine (BXCL501)	Placebo n=2 Participants Participants received a single sublingual matching placebo film	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: 120 minutes

Population: The study was terminated for business reasons, No data were collected for the outcome measures.

The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 120 minutes

Population: The study was terminated for business reasons, No data were collected for the outcome measures.

The Pittsburgh Agitation Scale (PAS) assesses agitation for individuals with dementia across four behavior groups: aberrant vocalizations, motor agitation, aggressiveness, and resisting care. Each behavior group is scored ranging from 0 (not present) to 4 (maximally present).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 120 minutes

Population: The study was terminated for business reasons, No data were collected for the outcome measures.

The Agitation-Calmness Evaluation Scale (ACES) is a single item measure rating overall agitation and sedation, where 1 indicates 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 120 minutes

Population: The study was terminated for business reasons, No data were collected for the outcome measures.

The Clinical Global Impression - Improvement (CGI-I) for agitation in response to treatment measures the current level of agitation relative to the level of agitation prior to administration of study intervention. The CGI-I scores range from 1 to 7 with a score of 1 indicating very much improved, and a score of 7 indicating very much worse.

Outcome measures

Outcome data not reported

Adverse Events

BXCL501: 40 Micrograms

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

BXCL501: 60 Micrograms

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	BXCL501: 40 Micrograms n=2 participants at risk Participants received a single sublingual film containing 40 micrograms Dexmedetomidine (BXCL501)	BXCL501: 60 Micrograms n=1 participants at risk Participants received a single sublingual film containing 60 micrograms Dexmedetomidine (BXCL501)	Placebo n=2 participants at risk Participants received a single sublingual matching placebo film
Gastrointestinal disorders Nausea	50.0% 1/2 • Day 1 to Day 7	0.00% 0/1 • Day 1 to Day 7	0.00% 0/2 • Day 1 to Day 7
Nervous system disorders Somnolence	50.0% 1/2 • Day 1 to Day 7	100.0% 1/1 • Day 1 to Day 7	0.00% 0/2 • Day 1 to Day 7
Infections and infestations Urinary tract infection	0.00% 0/2 • Day 1 to Day 7	100.0% 1/1 • Day 1 to Day 7	0.00% 0/2 • Day 1 to Day 7
Cardiac disorders Bradycardia	0.00% 0/2 • Day 1 to Day 7	100.0% 1/1 • Day 1 to Day 7	0.00% 0/2 • Day 1 to Day 7

Additional Information

Vice President Head of Clinical Operations

BioXcel Therapeutics

Phone: (475) 355 5177

Email: cgommoll@bioxceltherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place