At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 366 enrolled
Drug / intervention
Inhaled Placebo +2 moredrug
Likely dose
Inhaled Loxapine 1.25 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, Single Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Outpatients With Migraine Headache
In Brief
A Phase 2 clinical trial evaluating Inhaled Placebo, Inhaled Loxapine 1.25 mg, and 1 other intervention for Migraine Headache. Completed, enrolled 366 participants across 3 sites.
Detailed Summary
Assess the safety and efficacy of Staccato Loxapine in patients with moderate to severe migraine headache with or without aura in an outpatient setting.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Headache
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2009
First PostedJan 2009
Primary CompletionAug 2009
TodayJul 2026
First PostedJan 21, 2009
Enrollment StartJan 1, 2009
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.4 years ago
Interventions
Inhaled Placebodrug
Inhaled Staccato placebo (0 mg)
Inhaled Loxapine 1.25 mgdrug
Inhaled Staccato Loxapine 1.25 mg, single dose
Inhaled Loxapine 2.5 mgdrug
Inhaled Staccato Loxapine 1.25 mg, single dose