Trial Outcomes & Findings for Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia (NCT NCT04251910)
NCT ID: NCT04251910
Last Updated: 2023-09-21
Results Overview
The change in PEC score was evaluated at 2 hours following the administration of the BXCL501 60 mcg, and BXCL501 30 mcg (for Part A) and BXCL501 40 mcg (for Part B) versus placebo. PEC is the sum of 5 subscales (poor impulse control, tension, hostility, uncooperativeness, and excitement, each subscale ranging from 1 to 7) and thus ranges from 5 to 35. Change from baseline (pre-dose) PEC total score, with negative values is in favor of improvement.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Baseline and 2 hours post-dose
Results posted on
2023-09-21
Participant Flow
The trial was conducted at 4 sites in the United States from 27 December 2019 to 24 January 2022.
All the assessments were performed as per the schedule of the assessments.
Participant milestones
| Measure |
Part A-30 mcg BXCL501
Randomized patients self-administered 30 micrograms (mcg) of BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-60 mcg BXCL501
Randomized patients self-administered 60 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A- 90 mcg BXCL501
Randomized patients self-administered 90 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-Placebo
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Part B-40 Mcg-BXCL501
Randomized patients self-administered 40 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part B-Placebo
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
20
|
4
|
14
|
23
|
23
|
|
Overall Study
COMPLETED
|
16
|
15
|
4
|
10
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
0
|
4
|
1
|
0
|
Reasons for withdrawal
| Measure |
Part A-30 mcg BXCL501
Randomized patients self-administered 30 micrograms (mcg) of BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-60 mcg BXCL501
Randomized patients self-administered 60 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A- 90 mcg BXCL501
Randomized patients self-administered 90 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-Placebo
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Part B-40 Mcg-BXCL501
Randomized patients self-administered 40 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part B-Placebo
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
|---|---|---|---|---|---|---|
|
Overall Study
Covid 19 lockdown
|
0
|
5
|
0
|
4
|
0
|
0
|
|
Overall Study
Assisted living facility was closed
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia
Baseline characteristics by cohort
| Measure |
Part A-30 mcg BXCL501
n=16 Participants
Randomized patients self-administered 30 mcg of BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-60 mcg BXCL501
n=20 Participants
Randomized patients self-administered 60 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A- 90 mcg BXCL501
n=4 Participants
Randomized patients self-administered 90 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-Placebo
n=14 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Part B-40 Mcg-BXCL501
n=23 Participants
Randomized patients self-administered 40 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part B-Placebo
n=23 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
75.8 Years
STANDARD_DEVIATION 8.0 • n=93 Participants
|
77.7 Years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
68.8 Years
STANDARD_DEVIATION 7.9 • n=27 Participants
|
75.9 Years
STANDARD_DEVIATION 8.9 • n=483 Participants
|
77.4 Years
STANDARD_DEVIATION 8.2 • n=36 Participants
|
77.3 Years
STANDARD_DEVIATION 8.6 • n=10 Participants
|
76.6 Years
STANDARD_DEVIATION 8.0 • n=115 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
11 Participants
n=10 Participants
|
42 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
58 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
16 Participants
n=10 Participants
|
83 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
18 Participants
n=10 Participants
|
76 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 hours post-dosePopulation: The Intent to Treat Population consisted of all patients in the Safety Population who have a baseline and at least one post-baseline efficacy assessment.
The change in PEC score was evaluated at 2 hours following the administration of the BXCL501 60 mcg, and BXCL501 30 mcg (for Part A) and BXCL501 40 mcg (for Part B) versus placebo. PEC is the sum of 5 subscales (poor impulse control, tension, hostility, uncooperativeness, and excitement, each subscale ranging from 1 to 7) and thus ranges from 5 to 35. Change from baseline (pre-dose) PEC total score, with negative values is in favor of improvement.
Outcome measures
| Measure |
Part A-30 mcg BXCL501
n=16 Participants
Randomized patients self-administered 30 mcg of BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-60 mcg BXCL501
n=20 Participants
Randomized patients self-administered 60 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-90 mcg BXCL501
Randomized patients self-administered 90 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-Placebo
n=14 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Part B-40 Mcg-BXCL501
n=23 Participants
Randomized patients self-administered 40 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part B-Placebo
n=23 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Positive and Negative Syndrome Scale-Excited Component (PEC) Total Score
|
-5.4 score on a scale
Standard Deviation 3.4
|
-7.1 score on a scale
Standard Deviation 3.8
|
—
|
-2.9 score on a scale
Standard Deviation 2.7
|
-6.8 score on a scale
Standard Deviation 5.1
|
-1.8 score on a scale
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: Day 7 post dosePopulation: The safety population consisted of all patients who received study drug.
The safety and tolerability of single doses of BXCL501 was determined in treatment of acute agitation associated with dementia.
Outcome measures
| Measure |
Part A-30 mcg BXCL501
n=16 Participants
Randomized patients self-administered 30 mcg of BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-60 mcg BXCL501
n=20 Participants
Randomized patients self-administered 60 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-90 mcg BXCL501
n=4 Participants
Randomized patients self-administered 90 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-Placebo
n=14 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Part B-40 Mcg-BXCL501
n=23 Participants
Randomized patients self-administered 40 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part B-Placebo
n=23 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Adverse Events
|
11 Participants
|
14 Participants
|
4 Participants
|
0 Participants
|
12 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and at 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, Day 3, Day 7 post-dosePopulation: The Intent to Treat Population consisted of all patients in the Safety Population who have a baseline and at least one post-baseline efficacy assessment.
The onset and magnitude of calming effects of different doses of BXCL501 on symptoms of acute agitation associated with dementia was described as measured by the PAS. The PAS is an instrument that measured 4 behaviors namely: aberrant vocalization, motor agitation, aggressiveness and resisting to care. The patients are evaluated on a scale of 0 to 4, where 0 indicated no agitation and 4 indicated highest form of agitation. The PAS total score ranges from 0 to 16. Higher scores mean a worse outcome. Change in value of PAS total score, with negative value indicated the improvement in condition of the patients.
Outcome measures
| Measure |
Part A-30 mcg BXCL501
n=16 Participants
Randomized patients self-administered 30 mcg of BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-60 mcg BXCL501
n=20 Participants
Randomized patients self-administered 60 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-90 mcg BXCL501
Randomized patients self-administered 90 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-Placebo
n=14 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Part B-40 Mcg-BXCL501
n=23 Participants
Randomized patients self-administered 40 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part B-Placebo
n=23 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
|---|---|---|---|---|---|---|
|
Change in Pittsburgh Agitation Scale (PAS) Total Score From Baseline
30 minutes
|
-1.3 score on a scale
Standard Deviation 1.2
|
-1.6 score on a scale
Standard Deviation 1.7
|
—
|
-1.3 score on a scale
Standard Deviation 1.6
|
-1.3 score on a scale
Standard Deviation 2.8
|
-0.7 score on a scale
Standard Deviation 0.9
|
|
Change in Pittsburgh Agitation Scale (PAS) Total Score From Baseline
1 hour
|
-2.5 score on a scale
Standard Deviation 1.8
|
-4.0 score on a scale
Standard Deviation 2.2
|
—
|
-2.1 score on a scale
Standard Deviation 1.8
|
-4.7 score on a scale
Standard Deviation 3.2
|
-1.6 score on a scale
Standard Deviation 2.0
|
|
Change in Pittsburgh Agitation Scale (PAS) Total Score From Baseline
2 hours
|
-3.9 score on a scale
Standard Deviation 2.4
|
-5.8 score on a scale
Standard Deviation 2.1
|
—
|
-2.6 score on a scale
Standard Deviation 2.4
|
-5.4 score on a scale
Standard Deviation 3.4
|
-1.8 score on a scale
Standard Deviation 2.7
|
|
Change in Pittsburgh Agitation Scale (PAS) Total Score From Baseline
4 hours
|
-4.7 score on a scale
Standard Deviation 3.1
|
-6.4 score on a scale
Standard Deviation 1.3
|
—
|
-3.3 score on a scale
Standard Deviation 2.8
|
-5.2 score on a scale
Standard Deviation 3.7
|
-2.1 score on a scale
Standard Deviation 2.8
|
|
Change in Pittsburgh Agitation Scale (PAS) Total Score From Baseline
8 hours
|
-4.4 score on a scale
Standard Deviation 3.2
|
-6.2 score on a scale
Standard Deviation 1.7
|
—
|
-3.1 score on a scale
Standard Deviation 2.0
|
-4.1 score on a scale
Standard Deviation 3.5
|
-2.3 score on a scale
Standard Deviation 2.7
|
|
Change in Pittsburgh Agitation Scale (PAS) Total Score From Baseline
24 hours
|
-4.3 score on a scale
Standard Deviation 2.8
|
-4.9 score on a scale
Standard Deviation 2.1
|
—
|
-3.9 score on a scale
Standard Deviation 2.4
|
-2.0 score on a scale
Standard Deviation 2.2
|
-1.8 score on a scale
Standard Deviation 2.4
|
|
Change in Pittsburgh Agitation Scale (PAS) Total Score From Baseline
Day 3
|
-3.9 score on a scale
Standard Deviation 3.4
|
-4.9 score on a scale
Standard Deviation 2.4
|
—
|
-3.7 score on a scale
Standard Deviation 3.4
|
-2.0 score on a scale
Standard Deviation 1.9
|
-1.9 score on a scale
Standard Deviation 1.6
|
|
Change in Pittsburgh Agitation Scale (PAS) Total Score From Baseline
Day 7
|
-3.9 score on a scale
Standard Deviation 3.1
|
-4.3 score on a scale
Standard Deviation 2.3
|
—
|
-3.3 score on a scale
Standard Deviation 2.7
|
-2.6 score on a scale
Standard Deviation 3.3
|
-1.1 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline and 1 hour, 2 hours, 4 hours, 8 hours post-dosePopulation: The Intent to Treat Population consisted of all patients in the Safety Population who have a baseline and at least one post-baseline efficacy assessment. Here, number analyzed in each row signifies only the patients with available data that were analyzed for change in ACES score.
To evaluate the change in the total score of ACES from baseline to 8 hours post administration of 30 mcg, 60 mcg and 40 mcg compared to placebo. The ACES is a single item measure rating overall agitation and sedation which ranges from 1 to 9, 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. Change from baseline (pre-dose) ACES total score, with negative values in favor of improvement.
Outcome measures
| Measure |
Part A-30 mcg BXCL501
n=16 Participants
Randomized patients self-administered 30 mcg of BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-60 mcg BXCL501
n=20 Participants
Randomized patients self-administered 60 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-90 mcg BXCL501
Randomized patients self-administered 90 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-Placebo
n=14 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Part B-40 Mcg-BXCL501
n=23 Participants
Randomized patients self-administered 40 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part B-Placebo
n=23 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
|---|---|---|---|---|---|---|
|
Changes in Agitation-Calmness Evaluation Scale (ACES) Score From Baseline
1 hour
|
0.6 score on a scale
Standard Deviation 0.6
|
1.1 score on a scale
Standard Deviation 0.7
|
—
|
0.5 score on a scale
Standard Deviation 0.5
|
1.8 score on a scale
Standard Deviation 1.6
|
0.4 score on a scale
Standard Deviation 0.8
|
|
Changes in Agitation-Calmness Evaluation Scale (ACES) Score From Baseline
2 hours
|
0.9 score on a scale
Standard Deviation 1.0
|
2.7 score on a scale
Standard Deviation 1.6
|
—
|
0.9 score on a scale
Standard Deviation 0.9
|
2.5 score on a scale
Standard Deviation 1.9
|
0.7 score on a scale
Standard Deviation 1.3
|
|
Changes in Agitation-Calmness Evaluation Scale (ACES) Score From Baseline
4 hours
|
1.3 score on a scale
Standard Deviation 1.0
|
2.7 score on a scale
Standard Deviation 1.2
|
—
|
0.9 score on a scale
Standard Deviation 1.1
|
2.4 score on a scale
Standard Deviation 2.0
|
1.0 score on a scale
Standard Deviation 1.4
|
|
Changes in Agitation-Calmness Evaluation Scale (ACES) Score From Baseline
8 hours
|
1.4 score on a scale
Standard Deviation 1.1
|
2.2 score on a scale
Standard Deviation 0.9
|
—
|
0.9 score on a scale
Standard Deviation 0.8
|
1.5 score on a scale
Standard Deviation 1.5
|
1.0 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline and at 30 minutes, 1 hour, 4 hours, 8 hours, 24 hours, Day 3 and Day 7 post-dosePopulation: The Intent to Treat Population consisted of all patients in the Safety Population who have a baseline and at least one post-baseline efficacy assessment. Here, number analyzed in each row signifies only the patients with available data that were analyzed for change in PEC score.
The change in PEC score was evaluated following the administration of the BXCL501 60 mcg, and BXCL501 30 mcg (for Part A) and BXCL501 40 mcg (for Part B) versus placebo. PEC is the sum of 5 subscales (poor impulse control, tension, hostility, uncooperativeness, and excitement, each subscale ranging from 1 to 7) and thus ranges from 5 to 35. Change from baseline (pre-dose) PEC total score, with negative values is in favor of improvement.
Outcome measures
| Measure |
Part A-30 mcg BXCL501
n=16 Participants
Randomized patients self-administered 30 mcg of BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-60 mcg BXCL501
n=20 Participants
Randomized patients self-administered 60 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-90 mcg BXCL501
Randomized patients self-administered 90 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-Placebo
n=14 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Part B-40 Mcg-BXCL501
n=23 Participants
Randomized patients self-administered 40 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part B-Placebo
n=23 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
|---|---|---|---|---|---|---|
|
Changes in Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) Total Score From Baseline
30 minutes
|
-2.2 score on a scale
Standard Deviation 1.6
|
-1.7 score on a scale
Standard Deviation 2.2
|
—
|
-0.6 score on a scale
Standard Deviation 1.4
|
-1.0 score on a scale
Standard Deviation 2.4
|
-1.0 score on a scale
Standard Deviation 1.7
|
|
Changes in Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) Total Score From Baseline
1 hours
|
-3.6 score on a scale
Standard Deviation 1.9
|
-5.4 score on a scale
Standard Deviation 3.6
|
—
|
-2.3 score on a scale
Standard Deviation 2.0
|
-5.7 score on a scale
Standard Deviation 4.4
|
-1.9 score on a scale
Standard Deviation 3.2
|
|
Changes in Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) Total Score From Baseline
4 hours
|
-6.8 score on a scale
Standard Deviation 4.4
|
-8.1 score on a scale
Standard Deviation 2.5
|
—
|
-4.1 score on a scale
Standard Deviation 3.6
|
-6.5 score on a scale
Standard Deviation 4.5
|
-2.8 score on a scale
Standard Deviation 4.8
|
|
Changes in Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) Total Score From Baseline
8 hours
|
-7.1 score on a scale
Standard Deviation 4.6
|
-8.8 score on a scale
Standard Deviation 3.1
|
—
|
-4.6 score on a scale
Standard Deviation 3.3
|
-5.0 score on a scale
Standard Deviation 4.3
|
-3.2 score on a scale
Standard Deviation 4.7
|
|
Changes in Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) Total Score From Baseline
Day 2; 24 hours
|
-5.7 score on a scale
Standard Deviation 4.0
|
-6.0 score on a scale
Standard Deviation 3.8
|
—
|
-4.3 score on a scale
Standard Deviation 3.3
|
-3.4 score on a scale
Standard Deviation 3.7
|
-2.4 score on a scale
Standard Deviation 4.0
|
|
Changes in Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) Total Score From Baseline
Day 3
|
-5.3 score on a scale
Standard Deviation 5.0
|
-5.9 score on a scale
Standard Deviation 4.2
|
—
|
-3.9 score on a scale
Standard Deviation 3.7
|
-3.2 score on a scale
Standard Deviation 3.3
|
-1.8 score on a scale
Standard Deviation 2.7
|
|
Changes in Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) Total Score From Baseline
Day 7
|
-4.9 score on a scale
Standard Deviation 3.9
|
-4.6 score on a scale
Standard Deviation 3.9
|
—
|
-3.4 score on a scale
Standard Deviation 4.4
|
-2.5 score on a scale
Standard Deviation 4.1
|
-1.5 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline and 2 hours post-dosePopulation: The Intent to Treat Population consisted of all patients in the Safety Population who have a baseline and at least one post-baseline efficacy assessment.
The Number of patients who achieved a 40%reduction in total PEC score from baseline at 2 hours following administration of BXCL501 30 mcg, 60 mcg (for Part A) and BXCL501 40 mcg (for Part B) compared to placebo were evaluated. Responder defined as achieving \>= 40% reduction in PEC from baseline (pre-dose). The change from baseline in (pre-dose) PEC total score is presented for the Primary Outcome above.
Outcome measures
| Measure |
Part A-30 mcg BXCL501
n=16 Participants
Randomized patients self-administered 30 mcg of BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-60 mcg BXCL501
n=20 Participants
Randomized patients self-administered 60 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-90 mcg BXCL501
Randomized patients self-administered 90 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-Placebo
n=14 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Part B-40 Mcg-BXCL501
n=23 Participants
Randomized patients self-administered 40 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part B-Placebo
n=23 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
|---|---|---|---|---|---|---|
|
Number of Patients at Each Dose Who Achieve a 40% Reduction From Baseline in PEC Total Score at 2 Hours Post-dose ("Responders")
|
4 Participants
|
14 Participants
|
—
|
1 Participants
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and at 2 hours, and 24 hours post-dosePopulation: The Intent to Treat Population consisted of all patients in the Safety Population who have a baseline and at least one post-baseline efficacy assessment.
The CGI-S was based upon the severity of agitation. It was assessed based on the following scale: 0 = Not assessed; 1 = Normal not at all symptomatic; 2 = Minimally symptomatic- few or mild symptoms -little interference with patients functioning; 3 = Mildly symptomatic-low level of symptoms-little interference in social functioning; 4 = Moderately symptomatic-some prominent symptoms-some interference in functioning; 5 = Markedly symptomatic-significant symptoms with very substantial interference in functioning; 6 = Severely symptomatic- very marked symptoms make it difficult for patients to engage with others; 7 = Among the most extremely symptomatic patients-extreme symptoms -patient is incapacitated or highly dangerous to self or others requires extra care and supervision. The higher the score, the higher is the severity of the agitation and lesser the score, the lower the agitation. Change from baseline CGIS total score, with negative values in favor of improvement.
Outcome measures
| Measure |
Part A-30 mcg BXCL501
n=16 Participants
Randomized patients self-administered 30 mcg of BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-60 mcg BXCL501
n=20 Participants
Randomized patients self-administered 60 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-90 mcg BXCL501
Randomized patients self-administered 90 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-Placebo
n=14 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Part B-40 Mcg-BXCL501
n=23 Participants
Randomized patients self-administered 40 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part B-Placebo
n=23 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
|---|---|---|---|---|---|---|
|
Change in Clinician Global Impression of Severity (CGI-S) Agitation Score From Baseline
2 hours
|
-1.3 score on a scale
Standard Deviation 0.8
|
-2.1 score on a scale
Standard Deviation 0.9
|
—
|
-0.9 score on a scale
Standard Deviation 0.9
|
-2.2 score on a scale
Standard Deviation 1.3
|
-0.7 score on a scale
Standard Deviation 1.0
|
|
Change in Clinician Global Impression of Severity (CGI-S) Agitation Score From Baseline
24 hours
|
-1.4 score on a scale
Standard Deviation 1.1
|
-1.6 score on a scale
Standard Deviation 0.9
|
—
|
-1.2 score on a scale
Standard Deviation 1.1
|
-1.2 score on a scale
Standard Deviation 1.1
|
-0.7 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours post-dosePopulation: The Intent to Treat Population consisted of all patients in the Safety Population who have a baseline and at least one post-baseline efficacy assessment. Here, number analyzed in each row signifies only the patients with available data that were analyzed for CGI-I agitation score.
To evaluate the CGI-I agitation score at 30 minutes, 1 hour, 2 hours, and 8 hours after administration of 30 mcg, 60 mcg and 40 mcg of BXCL501 compared to placebo. The CGI-I scores range from 1 to 7 comprise of 0 = Not assessed (missing), 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. The lower score (1) indicated the improvement in the condition of patient and higher score (7) indicates the worsening of the condition. Straight CGI-I total score, with lower values in favor of improvement.
Outcome measures
| Measure |
Part A-30 mcg BXCL501
n=16 Participants
Randomized patients self-administered 30 mcg of BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-60 mcg BXCL501
n=20 Participants
Randomized patients self-administered 60 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-90 mcg BXCL501
Randomized patients self-administered 90 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-Placebo
n=14 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Part B-40 Mcg-BXCL501
n=23 Participants
Randomized patients self-administered 40 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part B-Placebo
n=23 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
|---|---|---|---|---|---|---|
|
Clinical Global Impression - Improvement (CGI-I) Agitation Score
30 minutes
|
3.3 score on a scale
Standard Error 0.2
|
3.4 score on a scale
Standard Error 0.2
|
—
|
3.5 score on a scale
Standard Error 0.2
|
3.5 score on a scale
Standard Error 0.1
|
3.7 score on a scale
Standard Error 0.1
|
|
Clinical Global Impression - Improvement (CGI-I) Agitation Score
1 hour
|
3.0 score on a scale
Standard Error 0.2
|
2.6 score on a scale
Standard Error 0.2
|
—
|
3.3 score on a scale
Standard Error 0.2
|
2.5 score on a scale
Standard Error 0.2
|
3.5 score on a scale
Standard Error 0.2
|
|
Clinical Global Impression - Improvement (CGI-I) Agitation Score
2 hours
|
2.4 score on a scale
Standard Error 0.2
|
1.6 score on a scale
Standard Error 0.2
|
—
|
3.2 score on a scale
Standard Error 0.2
|
1.9 score on a scale
Standard Error 0.2
|
3.6 score on a scale
Standard Error 0.2
|
|
Clinical Global Impression - Improvement (CGI-I) Agitation Score
4 hours
|
2.4 score on a scale
Standard Error 0.3
|
1.5 score on a scale
Standard Error 0.2
|
—
|
3.0 score on a scale
Standard Error 0.3
|
2.0 score on a scale
Standard Error 0.3
|
3.3 score on a scale
Standard Error 0.3
|
|
Clinical Global Impression - Improvement (CGI-I) Agitation Score
8 hours
|
2.3 score on a scale
Standard Error 0.2
|
1.4 score on a scale
Standard Error 0.2
|
—
|
3.0 score on a scale
Standard Error 0.2
|
2.5 score on a scale
Standard Error 0.3
|
3.5 score on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and at 2 Hours and Day 7 post-dosePopulation: The Intent to Treat Population consisted of all patients in the Safety Population who have a baseline and at least one post-baseline efficacy assessment.
To evaluate the change in Cohen Mansfield Agitation Inventory (CMAI) total score from baseline after 2 hour and on Day 7 post administration of 30 mcg, 60 mcg and 40 mcg BXCL501 compared to placebo. The CMAI is a rating which is comprised of 29 behaviors each rated on a 7-point scale of frequency. A total CMAI score is obtained by summing all the individual items, giving a range from 29 to 203. Change from baseline (pre-dose) CMAI total score, with negative values in favor of improvement in the condition of the patients.
Outcome measures
| Measure |
Part A-30 mcg BXCL501
n=16 Participants
Randomized patients self-administered 30 mcg of BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-60 mcg BXCL501
n=20 Participants
Randomized patients self-administered 60 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-90 mcg BXCL501
Randomized patients self-administered 90 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-Placebo
n=14 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Part B-40 Mcg-BXCL501
n=23 Participants
Randomized patients self-administered 40 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part B-Placebo
n=23 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
|---|---|---|---|---|---|---|
|
Change in Cohen Mansfield Agitation Inventory (CMAI) Total Score From Baseline
2 hours
|
-8.9 score on a scale
Standard Deviation 5.1
|
-14.7 score on a scale
Standard Deviation 9.8
|
—
|
1.6 score on a scale
Standard Deviation 4.5
|
-17.9 score on a scale
Standard Deviation 22.7
|
-5.7 score on a scale
Standard Deviation 14.0
|
|
Change in Cohen Mansfield Agitation Inventory (CMAI) Total Score From Baseline
Day 7
|
-5.9 score on a scale
Standard Deviation 4.3
|
-6.6 score on a scale
Standard Deviation 6.7
|
—
|
0.4 score on a scale
Standard Deviation 9.8
|
-6.9 score on a scale
Standard Deviation 17.7
|
-1.4 score on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: At 30 minutes post-dosePopulation: The safety population consisted of all patients who received study drug.
To evaluate the time taken for BXCL501 30 mcg, 60mcg, 90 mcg and 40 mcg compared to placebo to dissolve which was measured after 30 minutes of administration.
Outcome measures
| Measure |
Part A-30 mcg BXCL501
n=16 Participants
Randomized patients self-administered 30 mcg of BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-60 mcg BXCL501
n=20 Participants
Randomized patients self-administered 60 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-90 mcg BXCL501
n=4 Participants
Randomized patients self-administered 90 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-Placebo
n=14 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Part B-40 Mcg-BXCL501
n=23 Participants
Randomized patients self-administered 40 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part B-Placebo
n=23 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Event "Time Taken for Medication to Dissolve"
1- 30 seconds
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Event "Time Taken for Medication to Dissolve"
31- 59 seconds
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Event "Time Taken for Medication to Dissolve"
1- 2 minutes
|
10 Participants
|
8 Participants
|
2 Participants
|
8 Participants
|
12 Participants
|
10 Participants
|
|
Number of Patients With Event "Time Taken for Medication to Dissolve"
3+ minutes
|
6 Participants
|
12 Participants
|
2 Participants
|
6 Participants
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: At 30 minutes, 2 hours, 4 hours, 24 hours post dosePopulation: The safety population consisted of all patients who received study drug.
To evaluate the number patient showing negative reactions to sublingual film by assessing the buccal at 30 minutes, 2 hours, 4 hours and 24 hours post administration of 30mcg, 60 mcg, 40 mcg and 90 mcg v/s placebo. The larger number of patients reporting negative reaction, the lesser is the reliability of the drug.
Outcome measures
| Measure |
Part A-30 mcg BXCL501
n=16 Participants
Randomized patients self-administered 30 mcg of BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-60 mcg BXCL501
n=20 Participants
Randomized patients self-administered 60 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-90 mcg BXCL501
n=4 Participants
Randomized patients self-administered 90 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-Placebo
n=14 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Part B-40 Mcg-BXCL501
n=23 Participants
Randomized patients self-administered 40 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part B-Placebo
n=23 Participants
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
|---|---|---|---|---|---|---|
|
Number of Patients Showing Negative Reaction to Sublingual Film in the Examiner's Opinion
30 minutes Post dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients Showing Negative Reaction to Sublingual Film in the Examiner's Opinion
2 hours post dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients Showing Negative Reaction to Sublingual Film in the Examiner's Opinion
4 hours post dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients Showing Negative Reaction to Sublingual Film in the Examiner's Opinion
24 hours post dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and at 2 hours post-dosePopulation: The Intent to Treat Population consisted of all patients in the Safety Population who have a baseline and at least one post-baseline efficacy assessment.
To evaluate the change in PANSS Supplementary Items Total Score from Baseline to 2 hours post administration of 40 mcg of BXCL501 compared to placebo. PANSS Supplementary Items: The total score (sum score of anger, difficulty in delaying gratification, and affective lability) ranges from 3 to 21. The higher score indicates the worsening of the condition and lower score indicates the improvement of the condition of the patient. Change from baseline (pre-dose) PANSS Supplementary Items total score, with negative values in favor of improvement.
Outcome measures
| Measure |
Part A-30 mcg BXCL501
n=23 Participants
Randomized patients self-administered 30 mcg of BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-60 mcg BXCL501
n=22 Participants
Randomized patients self-administered 60 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-90 mcg BXCL501
Randomized patients self-administered 90 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-Placebo
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Part B-40 Mcg-BXCL501
Randomized patients self-administered 40 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part B-Placebo
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in the Total Score of 3 Supplementary Items of Positive and Negative Syndrome Scale (PANSS)
|
-3.7 score on a scale
Standard Deviation 2.9
|
-0.6 score on a scale
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
Adverse Events
Part A-30 mcg BXCL501
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part A-60 mcg BXCL501
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Part A- 90 mcg BXCL501
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A-Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B-40 Mcg-BXCL501
Serious events: 1 serious events
Other events: 12 other events
Deaths: 1 deaths
Part B-Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A-30 mcg BXCL501
n=16 participants at risk
Randomized patients self-administered 30 mcg of BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-60 mcg BXCL501
n=20 participants at risk
Randomized patients self-administered 60 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A- 90 mcg BXCL501
n=4 participants at risk
Randomized patients self-administered 90 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-Placebo
n=14 participants at risk
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Part B-40 Mcg-BXCL501
n=23 participants at risk
Randomized patients self-administered 40 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part B-Placebo
n=23 participants at risk
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/16 • Day 7 post-dose
|
0.00%
0/20 • Day 7 post-dose
|
0.00%
0/4 • Day 7 post-dose
|
0.00%
0/14 • Day 7 post-dose
|
4.3%
1/23 • Number of events 1 • Day 7 post-dose
|
0.00%
0/23 • Day 7 post-dose
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/16 • Day 7 post-dose
|
0.00%
0/20 • Day 7 post-dose
|
0.00%
0/4 • Day 7 post-dose
|
0.00%
0/14 • Day 7 post-dose
|
4.3%
1/23 • Number of events 1 • Day 7 post-dose
|
0.00%
0/23 • Day 7 post-dose
|
Other adverse events
| Measure |
Part A-30 mcg BXCL501
n=16 participants at risk
Randomized patients self-administered 30 mcg of BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-60 mcg BXCL501
n=20 participants at risk
Randomized patients self-administered 60 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A- 90 mcg BXCL501
n=4 participants at risk
Randomized patients self-administered 90 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part A-Placebo
n=14 participants at risk
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
Part B-40 Mcg-BXCL501
n=23 participants at risk
Randomized patients self-administered 40 mcg BXCL501 sublingually under the supervision of a trained staff member.
|
Part B-Placebo
n=23 participants at risk
Randomized patients self-administered Placebo sublingually under the supervision of a trained staff member.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
56.2%
9/16 • Day 7 post-dose
|
60.0%
12/20 • Day 7 post-dose
|
75.0%
3/4 • Day 7 post-dose
|
0.00%
0/14 • Day 7 post-dose
|
34.8%
8/23 • Day 7 post-dose
|
8.7%
2/23 • Day 7 post-dose
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Day 7 post-dose
|
5.0%
1/20 • Day 7 post-dose
|
50.0%
2/4 • Day 7 post-dose
|
0.00%
0/14 • Day 7 post-dose
|
4.3%
1/23 • Day 7 post-dose
|
0.00%
0/23 • Day 7 post-dose
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • Day 7 post-dose
|
5.0%
1/20 • Day 7 post-dose
|
0.00%
0/4 • Day 7 post-dose
|
0.00%
0/14 • Day 7 post-dose
|
0.00%
0/23 • Day 7 post-dose
|
0.00%
0/23 • Day 7 post-dose
|
|
Vascular disorders
Orthostatic hypotension
|
6.2%
1/16 • Day 7 post-dose
|
5.0%
1/20 • Day 7 post-dose
|
75.0%
3/4 • Day 7 post-dose
|
0.00%
0/14 • Day 7 post-dose
|
0.00%
0/23 • Day 7 post-dose
|
0.00%
0/23 • Day 7 post-dose
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • Day 7 post-dose
|
10.0%
2/20 • Day 7 post-dose
|
25.0%
1/4 • Day 7 post-dose
|
0.00%
0/14 • Day 7 post-dose
|
8.7%
2/23 • Day 7 post-dose
|
0.00%
0/23 • Day 7 post-dose
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/16 • Day 7 post-dose
|
5.0%
1/20 • Day 7 post-dose
|
0.00%
0/4 • Day 7 post-dose
|
0.00%
0/14 • Day 7 post-dose
|
0.00%
0/23 • Day 7 post-dose
|
0.00%
0/23 • Day 7 post-dose
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16 • Day 7 post-dose
|
5.0%
1/20 • Day 7 post-dose
|
0.00%
0/4 • Day 7 post-dose
|
0.00%
0/14 • Day 7 post-dose
|
4.3%
1/23 • Day 7 post-dose
|
0.00%
0/23 • Day 7 post-dose
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • Day 7 post-dose
|
5.0%
1/20 • Day 7 post-dose
|
0.00%
0/4 • Day 7 post-dose
|
0.00%
0/14 • Day 7 post-dose
|
4.3%
1/23 • Day 7 post-dose
|
0.00%
0/23 • Day 7 post-dose
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • Day 7 post-dose
|
0.00%
0/20 • Day 7 post-dose
|
0.00%
0/4 • Day 7 post-dose
|
0.00%
0/14 • Day 7 post-dose
|
4.3%
1/23 • Day 7 post-dose
|
0.00%
0/23 • Day 7 post-dose
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/16 • Day 7 post-dose
|
0.00%
0/20 • Day 7 post-dose
|
0.00%
0/4 • Day 7 post-dose
|
0.00%
0/14 • Day 7 post-dose
|
13.0%
3/23 • Day 7 post-dose
|
0.00%
0/23 • Day 7 post-dose
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/16 • Day 7 post-dose
|
0.00%
0/20 • Day 7 post-dose
|
0.00%
0/4 • Day 7 post-dose
|
0.00%
0/14 • Day 7 post-dose
|
4.3%
1/23 • Day 7 post-dose
|
0.00%
0/23 • Day 7 post-dose
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • Day 7 post-dose
|
0.00%
0/20 • Day 7 post-dose
|
0.00%
0/4 • Day 7 post-dose
|
0.00%
0/14 • Day 7 post-dose
|
4.3%
1/23 • Day 7 post-dose
|
0.00%
0/23 • Day 7 post-dose
|
Additional Information
Vice President Head of Clinical Operations
BioXcel Therapeutics
Phone: (475) 355 5177
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place