Trial · NCT00721955
Staccato Loxapine in Agitated Patients With Bipolar Disorder
NCT00721955, 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 Bipolar Disorder. Trials, record NCT00721955. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00721955
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Staccato Loxapine in Agitated Patients With Bipolar Disorder
- NCT number
- NCT00721955
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 314 participants, actual
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Conditions
- Bipolar I Disorder
- Interventions
- Inhaled Placebo, Inhaled loxapine 5 mg, Inhaled loxapine 10 mg
- First posted
- 2008-07-25
- 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 Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo | 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 Following Dose #1 of Staccato Loxapine, Compared With Placebo | 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 Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo | Baseline and 2 hours | ITT Population with LOCF | units on a scale | MEAN |
| SECONDARY | Clinical Global Impression-Improvement (CGI-I) Score Following Dose #1 of Staccato Loxapine, Compared With Placebo | 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 | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo | Inhaled Placebo | -4.9 | Standard Deviation 4.77 | units on a scale | |
| Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo | Inhaled Loxapine 5 mg | -8.1 | Standard Deviation 4.90 | units on a scale | |
| Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo | Inhaled Loxapine 10 mg | -9.0 | Standard Deviation 4.67 | units on a scale | |
| Clinical Global Impression-Improvement (CGI-I) Score Following Dose #1 of Staccato Loxapine, Compared With Placebo | Inhaled Placebo | 3.0 | Standard Deviation 0.99 | units on a scale | |
| Clinical Global Impression-Improvement (CGI-I) Score Following Dose #1 of Staccato Loxapine, Compared With Placebo | Inhaled Loxapine 5 mg | 2.1 | Standard Deviation 1.10 | units on a scale | |
| Clinical Global Impression-Improvement (CGI-I) Score Following Dose #1 of Staccato Loxapine, Compared With Placebo | Inhaled Loxapine 10 mg | 1.9 | Standard Deviation 1.14 | units on a scale | |
| CGI-I Responders | Inhaled Placebo | 29 | Participants | ||
| CGI-I Responders | Inhaled Loxapine 5 mg | 69 | Participants | ||
| CGI-I Responders | Inhaled Loxapine 10 mg | 78 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Inhaled Placebo | 105 | |
| Overall Study | STARTED | Inhaled Loxapine 5 mg | 104 | |
| Overall Study | STARTED | Inhaled Loxapine 10 mg | 105 | |
| Overall Study | COMPLETED | Inhaled Placebo | 105 | |
| Overall Study | COMPLETED | Inhaled Loxapine 5 mg | 104 | |
| Overall Study | COMPLETED | Inhaled Loxapine 10 mg | 103 | |
| Overall Study | NOT COMPLETED | Inhaled Placebo | 0 | |
| Overall Study | NOT COMPLETED | Inhaled Loxapine 5 mg | 0 | |
| Overall Study | NOT COMPLETED | Inhaled Loxapine 10 mg | 2 |
Source ClinicalTrials.gov
Adverse events12
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 | 6 | 105 | 6 |
| other | Dysgeusia | Gastrointestinal disorders | Inhaled Loxapine 5 mg | 18 | 104 | 18 |
| other | Dysgeusia | Gastrointestinal disorders | Inhaled Loxapine 10 mg | 18 | 105 | 18 |
| other | Dizziness | Nervous system disorders | Inhaled Placebo | 8 | 105 | 8 |
| other | Dizziness | Nervous system disorders | Inhaled Loxapine 5 mg | 6 | 104 | 6 |
| other | Dizziness | Nervous system disorders | Inhaled Loxapine 10 mg | 5 | 105 | 5 |
| other | Headache | Musculoskeletal and connective tissue disorders | Inhaled Placebo | 9 | 105 | 9 |
| other | Headache | Musculoskeletal and connective tissue disorders | Inhaled Loxapine 5 mg | 4 | 104 | 4 |
| other | Headache | Musculoskeletal and connective tissue disorders | Inhaled Loxapine 10 mg | 2 | 105 | 2 |
| other | Sedation | Nervous system disorders | Inhaled Placebo | 3 | 105 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Inhaled Placebo | 0 | 105 |
| Total, all-cause mortality | Inhaled Loxapine 5 mg | 0 | 104 |
| Total, all-cause mortality | Inhaled Loxapine 10 mg | 0 | 105 |
| Total, other adverse events | Inhaled Placebo | 26 | 105 |
| Total, other adverse events | Inhaled Loxapine 5 mg | 35 | 104 |
| Total, other adverse events | Inhaled Loxapine 10 mg | 31 | 105 |
| Total, serious adverse events | Inhaled Placebo | 0 | 105 |
| Total, serious adverse events | Inhaled Loxapine 5 mg | 0 | 104 |
| Total, serious adverse events | Inhaled Loxapine 10 mg | 0 | 105 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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.
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/NCT00721955
GET https://conductscience.org/api/trials/v1/NCT00721955/registered