Trial · NCT00628589

Staccato Loxapine in Agitated Patients With Schizophrenia

NCT00628589, Phase 3, Completed, Alexza Pharmaceuticals, Inc.; results first posted 2017-06-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Staccato Loxapine in Agitated Patients With Schizophrenia. Trials, record NCT00628589. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00628589

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Staccato Loxapine in Agitated Patients With Schizophrenia
NCT number: NCT00628589
Status: Completed
Phases: Phase 3
Enrollment: 344 participants, actual
Lead sponsor: Alexza Pharmaceuticals, Inc.
Conditions: Patients With Schizophrenia and Acute Agitation
Interventions: Inhaled loxapine 5 mg, Inhaled loxapine 10 mg, Inhaled placebo
First posted: 2008-03-05
Last updated: 2017-07-26
Results first posted: 2017-06-29
Limitations and caveats: Because of the need to provide informed consent, the types of patients enrolled in the study may not have been representative of the most severely agitated patients who present for emergency care.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in PANSS-EC From Baseline	Baseline and 2 hours	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.
Secondary	Clinical Global Impression-Improvement (CGI-I) Score	Baseline and 2 hours	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.
Secondary	CGI-I Responders	Baseline and 2 hours	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)

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in PANSS-EC From Baseline	Baseline and 2 hours	ITT Population with LOCF	units on a scale	MEAN
SECONDARY	Clinical Global Impression-Improvement (CGI-I) Score	Baseline and 2 hours	ITT Population with LOCF	units on a scale	MEAN
SECONDARY	CGI-I Responders	Baseline and 2 hours	ITT Population with LOCF	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in PANSS-EC From Baseline	Inhaled Placebo	-5.5	Standard Deviation 4.92	units on a scale
Change in PANSS-EC From Baseline	Inhaled Loxapine 5 mg	-8.1	Standard Deviation 5.17	units on a scale
Change in PANSS-EC From Baseline	Inhaled Loxapine 10 mg	-8.6	Standard Deviation 4.37	units on a scale
Clinical Global Impression-Improvement (CGI-I) Score	Inhaled Placebo	2.8	Standard Deviation 1.11	units on a scale
Clinical Global Impression-Improvement (CGI-I) Score	Inhaled Loxapine 5 mg	2.3	Standard Deviation 1.24	units on a scale
Clinical Global Impression-Improvement (CGI-I) Score	Inhaled Loxapine 10 mg	2.1	Standard Deviation 1.00	units on a scale
CGI-I Responders	Inhaled Placebo	41		Participants
CGI-I Responders	Inhaled Loxapine 5 mg	66		Participants
CGI-I Responders	Inhaled Loxapine 10 mg	75		Participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Inhaled Placebo	115
Overall Study	STARTED	Inhaled Loxapine 5 mg	116
Overall Study	STARTED	Inhaled Loxapine 10 mg	113
Overall Study	COMPLETED	Inhaled Placebo	114
Overall Study	COMPLETED	Inhaled Loxapine 5 mg	114
Overall Study	COMPLETED	Inhaled Loxapine 10 mg	110
Overall Study	NOT COMPLETED	Inhaled Placebo	1
Overall Study	NOT COMPLETED	Inhaled Loxapine 5 mg	2
Overall Study	NOT COMPLETED	Inhaled Loxapine 10 mg	3

Source ClinicalTrials.gov

Adverse events21

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dysgeusia	Gastrointestinal disorders	Inhaled Placebo	3	115	3
other	Dysgeusia	Gastrointestinal disorders	Inhaled Loxapine 5 mg	10	116	10
other	Dysgeusia	Gastrointestinal disorders	Inhaled Loxapine 10 mg	12	113	12
other	Nausea	Gastrointestinal disorders	Inhaled Placebo	6	115	6
other	Nausea	Gastrointestinal disorders	Inhaled Loxapine 5 mg	1	116	1
other	Nausea	Gastrointestinal disorders	Inhaled Loxapine 10 mg	2	113	2
other	Dizziness	Nervous system disorders	Inhaled Placebo	11	115	11
other	Dizziness	Nervous system disorders	Inhaled Loxapine 5 mg	6	116	6
other	Dizziness	Nervous system disorders	Inhaled Loxapine 10 mg	12	113	12
other	Headache	Nervous system disorders	Inhaled Placebo	16	115	16

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Inhaled Placebo	0	115
Total, all-cause mortality	Inhaled Loxapine 5 mg	0	116
Total, all-cause mortality	Inhaled Loxapine 10 mg	0	113
Total, other adverse events	Inhaled Placebo	44	115
Total, other adverse events	Inhaled Loxapine 5 mg	35	116
Total, other adverse events	Inhaled Loxapine 10 mg	41	113
Total, serious adverse events	Inhaled Placebo	1	115
Total, serious adverse events	Inhaled Loxapine 5 mg	0	116
Total, serious adverse events	Inhaled Loxapine 10 mg	1	113

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21200077	BACKGROUND	PubMed
29163985	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00628589

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API reference For AI assistants