Trial Outcomes & Findings for Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder (NCT NCT04276883)
NCT ID: NCT04276883
Last Updated: 2023-09-11
Results Overview
The Positive and Negative Syndrome Scale-Excited Component (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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
380 participants
Primary outcome timeframe
Baseline and 120 minutes
Results posted on
2023-09-11
Participant Flow
Participant milestones
| Measure |
180 Micrograms
Sublingual film containing 180 Micrograms Dexmedetomidine
Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)
|
120 Micrograms
Sublingual film containing 120 Micrograms Dexmedetomidine
Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)
|
Placebo
Sublingual placebo film
Placebo Film: Placebo Film for BXCL501
|
|---|---|---|---|
|
Overall Study
STARTED
|
127
|
127
|
126
|
|
Overall Study
COMPLETED
|
123
|
119
|
120
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
6
|
Reasons for withdrawal
| Measure |
180 Micrograms
Sublingual film containing 180 Micrograms Dexmedetomidine
Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)
|
120 Micrograms
Sublingual film containing 120 Micrograms Dexmedetomidine
Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)
|
Placebo
Sublingual placebo film
Placebo Film: Placebo Film for BXCL501
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Randomized in error - di dnot receive treatment
|
1
|
1
|
0
|
Baseline Characteristics
Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder
Baseline characteristics by cohort
| Measure |
180 Micrograms
n=126 Participants
Sublingual film containing 180 Micrograms Dexmedetomidine
Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)
|
120 Micrograms
n=126 Participants
Sublingual film containing 120 Micrograms Dexmedetomidine
Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)
|
Placebo
n=126 Participants
Sublingual placebo film
Placebo Film: Placebo Film for BXCL501
|
Total
n=378 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
46.1 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
44.8 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
45.6 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
207 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
171 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
111 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
340 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
72 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
212 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
155 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Positive and Negative Syndrome Scale-Excited Component (PEC)
|
18.0 units on a scale
STANDARD_DEVIATION 3.0 • n=5 Participants
|
18.0 units on a scale
STANDARD_DEVIATION 2.7 • n=7 Participants
|
17.9 units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
18.0 units on a scale
STANDARD_DEVIATION 2.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 120 minutesPopulation: Intent-to-Treat population, defined as all participants in the safety population who have a PEC score post-dose.
The Positive and Negative Syndrome Scale-Excited Component (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).
Outcome measures
| Measure |
180 Micrograms
n=126 Participants
Sublingual film containing 180 Micrograms Dexmedetomidine
Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)
|
120 Micrograms
n=126 Participants
Sublingual film containing 120 Micrograms Dexmedetomidine
Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)
|
Placebo
n=126 Participants
Sublingual placebo film
Placebo Film: Placebo Film for BXCL501
|
|---|---|---|---|
|
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
Baseline
|
18.0 score on a scale
Standard Deviation 2.99
|
18.0 score on a scale
Standard Deviation 2.73
|
17.9 score on a scale
Standard Deviation 2.94
|
|
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
Change from Baseline at 120 Minutes
|
-10.4 score on a scale
Standard Deviation 4.45
|
-9.0 score on a scale
Standard Deviation 5.26
|
-4.9 score on a scale
Standard Deviation 4.67
|
SECONDARY outcome
Timeframe: Baseline and 20, 30, 45, 60, 90, 120 minutes post-dosePopulation: Intent-to-Treat population, defined as all participants in the safety population who have a PEC score post-dose.
Effect on agitation onset was measured by change from baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) total score. The Positive and Negative Syndrome Scale-Excited Component (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).
Outcome measures
| Measure |
180 Micrograms
n=126 Participants
Sublingual film containing 180 Micrograms Dexmedetomidine
Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)
|
120 Micrograms
n=126 Participants
Sublingual film containing 120 Micrograms Dexmedetomidine
Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)
|
Placebo
n=126 Participants
Sublingual placebo film
Placebo Film: Placebo Film for BXCL501
|
|---|---|---|---|
|
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time
Baseline
|
18 score on a scale
Standard Deviation 2.99
|
18 score on a scale
Standard Deviation 2.73
|
17.9 score on a scale
Standard Deviation 2.94
|
|
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time
Change from Baseline at 20 minutes
|
-3.1 score on a scale
Standard Deviation 4.45
|
-2.9 score on a scale
Standard Deviation 3.83
|
-1.9 score on a scale
Standard Deviation 3
|
|
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time
Change from Baseline at 30 minutes
|
-4.6 score on a scale
Standard Deviation 5.08
|
-4.3 score on a scale
Standard Deviation 4.86
|
-2.8 score on a scale
Standard Deviation 3.85
|
|
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time
Change from Baseline at 45 minutes
|
-6.7 score on a scale
Standard Deviation 5.12
|
-6.3 score on a scale
Standard Deviation 5.3
|
-3.6 score on a scale
Standard Deviation 4.14
|
|
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time
Change from Baseline at 60 minutes
|
-8.4 score on a scale
Standard Deviation 5.17
|
-7.5 score on a scale
Standard Deviation 5.19
|
-4.4 score on a scale
Standard Deviation 4.53
|
|
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time
Change from Baseline at 90 minutes
|
-9.7 score on a scale
Standard Deviation 4.90
|
-8.6 score on a scale
Standard Deviation 5.28
|
-4.7 score on a scale
Standard Deviation 4.52
|
|
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time
Change from Baseline at 120 minutes
|
-10.4 score on a scale
Standard Deviation 4.45
|
-9.0 score on a scale
Standard Deviation 5.26
|
-4.9 score on a scale
Standard Deviation 4.67
|
Adverse Events
180 Micrograms
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
120 Micrograms
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
180 Micrograms
n=126 participants at risk
Sublingual film containing 180 Micrograms Dexmedetomidine
Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)
|
120 Micrograms
n=126 participants at risk
Sublingual film containing 120 Micrograms Dexmedetomidine
Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)
|
Placebo
n=126 participants at risk
Sublingual placebo film
Placebo Film: Placebo Film for BXCL501
|
|---|---|---|---|
|
Nervous system disorders
Agitation
|
0.00%
0/126 • 30 days
|
0.79%
1/126 • 30 days
|
0.00%
0/126 • 30 days
|
Other adverse events
| Measure |
180 Micrograms
n=126 participants at risk
Sublingual film containing 180 Micrograms Dexmedetomidine
Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)
|
120 Micrograms
n=126 participants at risk
Sublingual film containing 120 Micrograms Dexmedetomidine
Sublingual film containing Dexmedetomidine (BXCL501): Sublingual film containing Dexmedetomidine (BXCL501)
|
Placebo
n=126 participants at risk
Sublingual placebo film
Placebo Film: Placebo Film for BXCL501
|
|---|---|---|---|
|
Nervous system disorders
Somnolence
|
21.4%
27/126 • 30 days
|
20.6%
26/126 • 30 days
|
4.8%
6/126 • 30 days
|
|
Nervous system disorders
Dizziness
|
5.6%
7/126 • 30 days
|
5.6%
7/126 • 30 days
|
0.79%
1/126 • 30 days
|
|
Nervous system disorders
Headache
|
1.6%
2/126 • 30 days
|
4.8%
6/126 • 30 days
|
4.8%
6/126 • 30 days
|
|
Gastrointestinal disorders
Dry mouth
|
4.8%
6/126 • 30 days
|
7.1%
9/126 • 30 days
|
0.79%
1/126 • 30 days
|
|
Gastrointestinal disorders
Nausea
|
4.0%
5/126 • 30 days
|
2.4%
3/126 • 30 days
|
2.4%
3/126 • 30 days
|
|
Gastrointestinal disorders
Hypoesthesia oral
|
4.0%
5/126 • 30 days
|
1.6%
2/126 • 30 days
|
0.79%
1/126 • 30 days
|
|
Vascular disorders
Hypotension
|
6.3%
8/126 • 30 days
|
4.8%
6/126 • 30 days
|
0.00%
0/126 • 30 days
|
|
Vascular disorders
Orthostatic hypotension
|
4.8%
6/126 • 30 days
|
4.0%
5/126 • 30 days
|
0.79%
1/126 • 30 days
|
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