Trial Outcomes & Findings for Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder (NCT NCT06041646)
NCT ID: NCT06041646
Last Updated: 2026-01-02
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
PHASE4
Target enrollment
29 participants
Primary outcome timeframe
Baseline and 2 hours post-dose for all doses administered over 7 days.
Results posted on
2026-01-02
Participant Flow
The study was conducted in the United States from 02Oct2023 to 29Apr2024.
Participant milestones
| Measure |
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
An initial dose of 180 µg of Igalmi as needed for the treatment of agitation over a period of 7 days. In the event of persistent or recurrent agitation, investigators may choose to repeat dose at 90 μg after the 2-hour time point in the absence of dose-limiting adverse events or safety concerns. A maximum of 2 repeat doses will be allowed in a 24-hour period.
Sublingual film containing Igalmi: Sublingual film containing 180 µg of Igalmi (dexmedetomidine)
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
An initial dose of 180 µg of Igalmi as needed for the treatment of agitation over a period of 7 days. In the event of persistent or recurrent agitation, investigators may choose to repeat dose at 90 μg after the 2-hour time point in the absence of dose-limiting adverse events or safety concerns. A maximum of 2 repeat doses will be allowed in a 24-hour period.
Sublingual film containing Igalmi: Sublingual film containing 180 µg of Igalmi (dexmedetomidine)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
n=29 Participants
An initial dose of 180 µg of Igalmi as needed for the treatment of agitation over a period of 7 days. In the event of persistent or recurrent agitation, investigators may choose to repeat dose at 90 μg after the 2-hour time point in the absence of dose-limiting adverse events or safety concerns. A maximum of 2 repeat doses will be allowed in a 24-hour period.
Sublingual film containing Igalmi: Sublingual film containing 180 µg of Igalmi (dexmedetomidine)
|
|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 8.85 • n=228 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=228 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=228 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=228 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=228 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=228 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=228 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=228 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=228 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=228 Participants
|
|
Diagnosis
Bipolar 1 or 2
|
17 Participants
n=228 Participants
|
|
Diagnosis
Schizophrenia
|
10 Participants
n=228 Participants
|
|
Diagnosis
Schizoaffective disorder
|
2 Participants
n=228 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 hours post-dose for all doses administered over 7 days.Population: For each dose the population consists only of patients who took that 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 |
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
n=28 Participants
An initial dose of 180 µg of Igalmi as needed for the treatment of agitation over a period of 7 days. In the event of persistent or recurrent agitation, investigators may choose to repeat dose at 90 μg after the 2-hour time point in the absence of dose-limiting adverse events or safety concerns. A maximum of 2 repeat doses will be allowed in a 24-hour period.
Sublingual film containing Igalmi: Sublingual film containing 180 µg of Igalmi (dexmedetomidine)
|
|---|---|
|
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
Dose 1
|
-10.4 score on a scale
Standard Deviation 2.94
|
|
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
Dose 2
|
-10.0 score on a scale
Standard Deviation 3.54
|
|
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
Dose 3
|
-10.1 score on a scale
Standard Deviation 3.60
|
|
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
Dose 4
|
-9.8 score on a scale
Standard Deviation 2.55
|
|
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
Dose 5
|
-11.5 score on a scale
Standard Deviation 4.51
|
|
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
Dose 6
|
-8.7 score on a scale
Standard Deviation 3.79
|
|
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
Dose 7
|
-11.0 score on a scale
Standard Deviation NA
Not available as only one patient is included.
|
PRIMARY outcome
Timeframe: 2 hours post-dose for all doses administered over 7 days.Population: For each dose only the patients who took that dose are included.
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
| Measure |
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
n=28 Participants
An initial dose of 180 µg of Igalmi as needed for the treatment of agitation over a period of 7 days. In the event of persistent or recurrent agitation, investigators may choose to repeat dose at 90 μg after the 2-hour time point in the absence of dose-limiting adverse events or safety concerns. A maximum of 2 repeat doses will be allowed in a 24-hour period.
Sublingual film containing Igalmi: Sublingual film containing 180 µg of Igalmi (dexmedetomidine)
|
|---|---|
|
Clinical Global Impression - Improvement (CGI-I)
Dose 4
|
1.0 score on a scale
Standard Deviation 0.00
|
|
Clinical Global Impression - Improvement (CGI-I)
Dose 5
|
1.2 score on a scale
Standard Deviation 0.41
|
|
Clinical Global Impression - Improvement (CGI-I)
Dose 1
|
1.2 score on a scale
Standard Deviation 0.50
|
|
Clinical Global Impression - Improvement (CGI-I)
Dose 2
|
1.2 score on a scale
Standard Deviation 0.39
|
|
Clinical Global Impression - Improvement (CGI-I)
Dose 3
|
1.3 score on a scale
Standard Deviation 0.47
|
|
Clinical Global Impression - Improvement (CGI-I)
Dose 6
|
1.3 score on a scale
Standard Deviation 0.58
|
|
Clinical Global Impression - Improvement (CGI-I)
Dose 7
|
2.0 score on a scale
Standard Deviation NA
Only one patient.
|
SECONDARY outcome
Timeframe: Day 8 through Day 10Evaluation of withdrawal phenomenon based on the occurrence of adverse events such as tachycardia, systolic hypertension, nausea, or vomiting and the emergence of any new adverse events on ≥2 consecutive days of the 3-day off-treatment follow-up period.
Outcome measures
| Measure |
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
n=28 Participants
An initial dose of 180 µg of Igalmi as needed for the treatment of agitation over a period of 7 days. In the event of persistent or recurrent agitation, investigators may choose to repeat dose at 90 μg after the 2-hour time point in the absence of dose-limiting adverse events or safety concerns. A maximum of 2 repeat doses will be allowed in a 24-hour period.
Sublingual film containing Igalmi: Sublingual film containing 180 µg of Igalmi (dexmedetomidine)
|
|---|---|
|
Number of Participants With Adverse Events During the Follow-up Period
|
0 Participants
|
Adverse Events
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Treatment - 180 mcg of Igalmi (Dexmedetomidine)
n=28 participants at risk
An initial dose of 180 µg of Igalmi as needed for the treatment of agitation over a period of 7 days. In the event of persistent or recurrent agitation, investigators may choose to repeat dose at 90 μg after the 2-hour time point in the absence of dose-limiting adverse events or safety concerns. A maximum of 2 repeat doses will be allowed in a 24-hour period.
Sublingual film containing Igalmi: Sublingual film containing 180 µg of Igalmi (dexmedetomidine)
|
|---|---|
|
Injury, poisoning and procedural complications
Contusion
|
3.6%
1/28 • Number of events 1 • 10 days
|
|
Injury, poisoning and procedural complications
Limb injury
|
3.6%
1/28 • Number of events 1 • 10 days
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
3.6%
1/28 • Number of events 1 • 10 days
|
|
Injury, poisoning and procedural complications
Tongue injury
|
3.6%
1/28 • Number of events 1 • 10 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • Number of events 1 • 10 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
1/28 • Number of events 1 • 10 days
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
3.6%
1/28 • Number of events 1 • 10 days
|
|
Nervous system disorders
Somnolence
|
10.7%
3/28 • Number of events 4 • 10 days
|
|
Nervous system disorders
Dizziness
|
3.6%
1/28 • Number of events 1 • 10 days
|
|
Nervous system disorders
Syncope
|
3.6%
1/28 • Number of events 1 • 10 days
|
|
Gastrointestinal disorders
Dry mouth
|
10.7%
3/28 • Number of events 5 • 10 days
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
1/28 • Number of events 1 • 10 days
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.6%
1/28 • Number of events 1 • 10 days
|
|
Gastrointestinal disorders
Hypoesthesia oral
|
3.6%
1/28 • Number of events 1 • 10 days
|
|
Vascular disorders
Hypotension
|
10.7%
3/28 • Number of events 3 • 10 days
|
|
Vascular disorders
Orthostatic hypotension
|
3.6%
1/28 • Number of events 1 • 10 days
|
|
Nervous system disorders
Headache
|
10.7%
3/28 • Number of events 3 • 10 days
|
Additional Information
SVP Clinical and Medical Affairs
BioXcel Therapeutics
Phone: (203) 530-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place