Phase 3
Completed N=344
Staccato Loxapine in Agitated Patients With Schizophrenia
Patients With Schizophrenia and Acute Agitation
Source: ClinicalTrials.gov NCT00628589 ↗
Enrolled (actual)
344
Serious AEs
0.6%
Results posted
Jun 2017
Primary outcomePrimary: Change in PANSS-EC From Baseline — -5.5; -8.1; -8.6 units on a scale — p=0.0004
◆ Published Evidence
Highly cited
153citations · ~10 / year
Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine.
Summary
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients
Linked Publications (2)
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Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine.
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Response to inhaled loxapine in patients with schizophrenia or bipolar I disorder: PANSS-EC responder analyses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PANSS-EC From Baseline |
-5.5; -8.1; -8.6 | 0.0004 sig |
| SECONDARY Clinical Global Impression-Improvement (CGI-I) Score |
2.8; 2.3; 2.1 | 0.0015 sig |
| SECONDARY CGI-I Responders |
41; 66; 75 | 0.0015 sig |
Eligibility Criteria
Inclusion Criteria
- Male and female adult patients with schizophrenia and acute agitation
Exclusion Criteria
- Agitation caused primarily by acute intoxication
- History of drug or alcohol dependence
- Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration
Data sourced from ClinicalTrials.gov (NCT00628589) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.