Staccato Loxapine in Agitated Patients With Bipolar Disorder
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
Sponsor: Alexza Pharmaceuticals, Inc.
Listed as NCT00721955, this PHASE3 trial focuses on Bipolar I Disorder and remains completed. Sponsored by Alexza Pharmaceuticals, Inc., it has been updated 9 times since 2008, reflecting limited change activity. Mental health research at this phase helps define safety and dosing parameters for future study.
Study Description(click to expand)This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.
This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.
Status Flow
Change History
9 versions recorded-
Feb 2026 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Feb 2026 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Dec 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Dec 2021 [monthly]
Completed PHASE3
▶ Show 4 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
-
Aug 2017 — Jun 2018 [monthly]
Completed PHASE3
-
Feb 2017 — Aug 2017 [monthly]
Completed PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Jul 2008
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 .