At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 314 enrolled
Drug / intervention
Inhaled Placebo +2 moredrug
Likely dose
Inhaled loxapine 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Patients With Bipolar I Disorder and Acute Agitation
In Brief
A Phase 3 clinical trial evaluating Inhaled Placebo, Inhaled loxapine 5 mg, and 1 other intervention for Bipolar I Disorder. Completed, enrolled 314 participants across 6 sites.
Detailed Summary
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar I Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedJul 2008
Primary CompletionOct 2008
TodayJul 2026
First PostedJul 25, 2008
Enrollment StartJul 1, 2008
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 17.9 years ago
Interventions
Inhaled Placebodrug
Inhaled loxapine Placebo, may repeat after 2 hours x 2
Inhaled loxapine 5 mgdrug
Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2
Inhaled loxapine 10 mgdrug
Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2