Trial Outcomes & Findings for Staccato Loxapine in Agitated Patients With Schizophrenia (NCT NCT00628589)
NCT ID: NCT00628589
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
344 participants
Primary outcome timeframe
Baseline and 2 hours
Results posted on
2017-07-26
Participant Flow
The study was conducted at 24 centers - all in the US. Patients recruited for screening were admitted to a hospital or research unit with acute agitation, and were being treated for chronic underlying schizophrenia.
During the Pre-treatment Period, agitated schizophrenic patients were screened for inclusion in the study. This period lasted until the evaluations were begun.
Participant milestones
| Measure |
Inhaled Placebo
Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
|
Inhaled Loxapine 5 mg
Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
|
Inhaled Loxapine 10 mg
Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
|
|---|---|---|---|
|
Overall Study
STARTED
|
115
|
116
|
113
|
|
Overall Study
COMPLETED
|
114
|
114
|
110
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Staccato Loxapine in Agitated Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Inhaled Placebo
n=115 Participants
Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
|
Inhaled Loxapine 5 mg
n=116 Participants
Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
|
Inhaled Loxapine 10 mg
n=113 Participants
Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
|
Total
n=344 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
|
115 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
344 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
|
43.9 years
STANDARD_DEVIATION 9.45 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 10.24 • n=7 Participants
|
42.2 years
STANDARD_DEVIATION 9.82 • n=5 Participants
|
43.1 years
STANDARD_DEVIATION 9.84 • n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
253 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
115 participants
n=5 Participants
|
116 participants
n=7 Participants
|
113 participants
n=5 Participants
|
344 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=115 Participants
Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
|
Inhaled Loxapine 5 mg
n=116 Participants
Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
|
Inhaled Loxapine 10 mg
n=112 Participants
Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
|
|---|---|---|---|
|
Change in PANSS-EC From Baseline
|
-5.5 units on a scale
Standard Deviation 4.92
|
-8.1 units on a scale
Standard Deviation 5.17
|
-8.6 units on a scale
Standard Deviation 4.37
|
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=115 Participants
Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
|
Inhaled Loxapine 5 mg
n=116 Participants
Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
|
Inhaled Loxapine 10 mg
n=112 Participants
Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
|
|---|---|---|---|
|
Clinical Global Impression-Improvement (CGI-I) Score
|
2.8 units on a scale
Standard Deviation 1.11
|
2.3 units on a scale
Standard Deviation 1.24
|
2.1 units on a scale
Standard Deviation 1.00
|
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=115 Participants
Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
|
Inhaled Loxapine 5 mg
n=116 Participants
Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
|
Inhaled Loxapine 10 mg
n=112 Participants
Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
|
|---|---|---|---|
|
CGI-I Responders
|
41 Participants
|
66 Participants
|
75 Participants
|
Adverse Events
Inhaled Placebo
Serious events: 1 serious events
Other events: 44 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: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Inhaled Placebo
n=115 participants at risk
Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
|
Inhaled Loxapine 5 mg
n=116 participants at risk
Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
|
Inhaled Loxapine 10 mg
n=113 participants at risk
Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
|
|---|---|---|---|
|
Psychiatric disorders
Exacerbation of schizophrenia
|
0.87%
1/115 • Number of events 1 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
0.00%
0/116 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
0.00%
0/113 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/115 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
0.00%
0/116 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
0.88%
1/113 • Number of events 1 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
Other adverse events
| Measure |
Inhaled Placebo
n=115 participants at risk
Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
|
Inhaled Loxapine 5 mg
n=116 participants at risk
Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
|
Inhaled Loxapine 10 mg
n=113 participants at risk
Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
|
|---|---|---|---|
|
Gastrointestinal disorders
Dysgeusia
|
2.6%
3/115 • 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.
|
8.6%
10/116 • Number of events 10 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
10.6%
12/113 • Number of events 12 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
|
Gastrointestinal disorders
Nausea
|
5.2%
6/115 • 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.
|
0.86%
1/116 • Number of events 1 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
1.8%
2/113 • 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
Dizziness
|
9.6%
11/115 • Number of events 11 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
5.2%
6/116 • 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.
|
10.6%
12/113 • Number of events 12 • 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
Headache
|
13.9%
16/115 • Number of events 16 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
2.6%
3/116 • 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.
|
2.7%
3/113 • 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.
|
|
Nervous system disorders
Sedation
|
9.6%
11/115 • Number of events 11 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
12.9%
15/116 • Number of events 15 • From informed consent through 30 days after last treatment
AEs were recorded when identified by the study center staff or volunteered by a patient.
|
10.6%
12/113 • Number of events 12 • 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
Executive VP, Research & Development, Regulatory & Quality
Alexza Pharmaceuticals, Inc
Phone: 650.944.7071
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER