Phase 3
N=314
Staccato Loxapine in Agitated Patients With Bipolar Disorder
Bipolar I Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00721955 ↗Enrolled (actual)
314
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo — -4.9; -8.1; -9.0 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Inhaled Placebo (Drug); Inhaled loxapine 5 mg (Drug); Inhaled loxapine 10 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alexza Pharmaceuticals, Inc.
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo |
-4.9; -8.1; -9.0 | <0.0001 sig |
| SECONDARY Clinical Global Impression-Improvement (CGI-I) Score Following Dose #1 of Staccato Loxapine, Compared With Placebo |
3.0; 2.1; 1.9 | <0.0001 sig |
| SECONDARY CGI-I Responders |
29; 69; 78 | — |
Summary
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.
Eligibility Criteria
Inclusion Criteria
- Male and female adult patients with bipolar 1 disorder 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 (NCT00721955). 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.