Phase 3
N=344
Staccato Loxapine in Agitated Patients With Schizophrenia
Patients With Schizophrenia and Acute Agitation
Bottom Line
View on ClinicalTrials.gov: NCT00628589 ↗Enrolled (actual)
344
Serious AEs
0.6%
Results posted
Jun 2017
Primary outcome: Primary: Change in PANSS-EC From Baseline — -5.5; -8.1; -8.6 units on a scale — p=0.0004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Inhaled loxapine 5 mg (Drug); Inhaled loxapine 10 mg (Drug); Inhaled placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alexza Pharmaceuticals, Inc.
- Primary completion
- May 2008
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 |
Summary
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients
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). 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.