Trial Outcomes & Findings for Staccato Loxapine in Agitated Patients With Bipolar Disorder (NCT NCT00721955)
NCT ID: NCT00721955
Last Updated: 2017-07-26
Results Overview
The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
314 participants
Primary outcome timeframe
Baseline and 2 hours
Results posted on
2017-07-26
Participant Flow
Participant milestones
| Measure |
Inhaled Placebo
Inhaled Staccato Placebo, may repeat after 2 hours x 2
Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2
|
Inhaled Loxapine 5 mg
Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2
|
Inhaled Loxapine 10 mg
Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2
|
|---|---|---|---|
|
Overall Study
STARTED
|
105
|
104
|
105
|
|
Overall Study
COMPLETED
|
105
|
104
|
103
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Inhaled Placebo
Inhaled Staccato Placebo, may repeat after 2 hours x 2
Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2
|
Inhaled Loxapine 5 mg
Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2
|
Inhaled Loxapine 10 mg
Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
Baseline Characteristics
Staccato Loxapine in Agitated Patients With Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Inhaled Placebo
n=105 Participants
Inhaled Staccato Placebo, may repeat after 2 hours x 2
Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2
|
Inhaled Loxapine 5 mg
n=104 Participants
Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2
|
Inhaled Loxapine 10 mg
n=105 Participants
Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2
|
Total
n=314 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
|
105 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
314 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 9.82 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 9.63 • n=7 Participants
|
40.5 years
STANDARD_DEVIATION 9.80 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 9.72 • n=4 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
105 participants
n=5 Participants
|
104 participants
n=7 Participants
|
105 participants
n=5 Participants
|
314 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 hoursPopulation: ITT Population with LOCF
The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.
Outcome measures
| Measure |
Inhaled Placebo
n=105 Participants
Inhaled Staccato Placebo, may repeat after 2 hours x 2
Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2
|
Inhaled Loxapine 5 mg
n=104 Participants
Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2
|
Inhaled Loxapine 10 mg
n=105 Participants
Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2
|
|---|---|---|---|
|
Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo
|
-4.9 units on a scale
Standard Deviation 4.77
|
-8.1 units on a scale
Standard Deviation 4.90
|
-9.0 units on a scale
Standard Deviation 4.67
|
SECONDARY outcome
Timeframe: Baseline and 2 hoursPopulation: ITT Population with LOCF
Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 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.
Outcome measures
| Measure |
Inhaled Placebo
n=105 Participants
Inhaled Staccato Placebo, may repeat after 2 hours x 2
Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2
|
Inhaled Loxapine 5 mg
n=104 Participants
Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2
|
Inhaled Loxapine 10 mg
n=105 Participants
Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2
|
|---|---|---|---|
|
Clinical Global Impression-Improvement (CGI-I) Score Following Dose #1 of Staccato Loxapine, Compared With Placebo
|
3.0 units on a scale
Standard Deviation 0.99
|
2.1 units on a scale
Standard Deviation 1.10
|
1.9 units on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Baseline and 2 hoursPopulation: ITT Population with LOCF
Frequency of response based on the CGI-I (defined as achieving a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)
Outcome measures
| Measure |
Inhaled Placebo
n=105 Participants
Inhaled Staccato Placebo, may repeat after 2 hours x 2
Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2
|
Inhaled Loxapine 5 mg
n=104 Participants
Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2
|
Inhaled Loxapine 10 mg
n=105 Participants
Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2
|
|---|---|---|---|
|
CGI-I Responders
|
29 Participants
|
69 Participants
|
78 Participants
|
Adverse Events
Inhaled Placebo
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Inhaled Loxapine 5 mg
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Inhaled Loxapine 10 mg
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Inhaled Placebo
n=105 participants at risk
Inhaled Staccato Placebo, may repeat after 2 hours x 2
Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2
|
Inhaled Loxapine 5 mg
n=104 participants at risk
Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2
|
Inhaled Loxapine 10 mg
n=105 participants at risk
Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2
|
|---|---|---|---|
|
Gastrointestinal disorders
Dysgeusia
|
5.7%
6/105 • Number of events 6 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
17.3%
18/104 • Number of events 18 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
17.1%
18/105 • Number of events 18 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
|
Nervous system disorders
Dizziness
|
7.6%
8/105 • Number of events 8 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
5.8%
6/104 • Number of events 6 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
4.8%
5/105 • Number of events 5 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
|
Musculoskeletal and connective tissue disorders
Headache
|
8.6%
9/105 • Number of events 9 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
3.8%
4/104 • Number of events 4 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
1.9%
2/105 • Number of events 2 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
|
Nervous system disorders
Sedation
|
2.9%
3/105 • Number of events 3 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
6.7%
7/104 • Number of events 7 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
5.7%
6/105 • Number of events 6 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60