Staccato Loxapine in Migraine (Out Patient)
A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Outpatients With Migraine Headache
Sponsor: Alexza Pharmaceuticals, Inc.
Listed as NCT00825500, this PHASE2 trial focuses on Migraine Headache and remains completed. Sponsored by Alexza Pharmaceuticals, Inc., it has been updated 12 times since 2009, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)This study was designed to compare the safety and pharmacodynamic profiles of concomitant administration of single doses of ADASUVE and intramuscular (IM) lorazepam compared to that of each agent administered alone. Respiratory pharmacodynamics were monitored through recordings of respirations/minute and pulse oximetry. Other pharmacodynamic safety measures included effects on blood pressure, heart rate, sedation, and psychomotor measures of attention, information processing speed, reaction time, and coordination.
This study was designed to compare the safety and pharmacodynamic profiles of concomitant administration of single doses of ADASUVE and intramuscular (IM) lorazepam compared to that of each agent administered alone. Respiratory pharmacodynamics were monitored through recordings of respirations/minute and pulse oximetry. Other pharmacodynamic safety measures included effects on blood pressure, heart rate, sedation, and psychomotor measures of attention, information processing speed, reaction time, and coordination.
Status Flow
Change History
12 versions recorded-
Mar 2026 — Present [monthly]
Completed PHASE2
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Feb 2026 — Present [monthly]
Completed PHASE2
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Jan 2026 — Present [monthly]
Completed PHASE2
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Sep 2024 — Feb 2026 [monthly]
Completed PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
▶ Show 7 earlier versions
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Jan 2023 — Jul 2024 [monthly]
Completed PHASE2
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Dec 2022 — Jan 2023 [monthly]
Completed PHASE2
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Jan 2021 — Dec 2022 [monthly]
Completed PHASE2
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
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Jun 2017 — Jun 2018 [monthly]
Completed PHASE2
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Feb 2017 — Jun 2017 [monthly]
Completed PHASE2
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE2
First recorded
Jan 2009
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Alexza Pharmaceuticals, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .