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NCT00721955 · ClinicalTrials.gov registry record · Phase 3
Staccato Loxapine in Agitated Patients With Bipolar Disorder
A Phase 3 study, sponsored by Alexza Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 314
- Enrollment target
NCT00721955: Completed Phase 3 study, sponsored by Alexza Pharmaceuticals.
NCT00721955 is a Phase 3 study that has completed, run by Alexza Pharmaceuticals. The registered enrollment target is 314 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00721955, a Phase 3 study, has completed, sponsored by Alexza Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 314 participants
- Enrollment target
Study Summary
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.
Primary Outcome
The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.
Interventions
- DRUG Inhaled Placebo
- DRUG Inhaled loxapine 5 mg
- DRUG Inhaled loxapine 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2008-07 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
What the finished NCT00721955 record still lists
NCT00721955 is an interventional study that assigns participants to a tested intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 3 interventions - of which Inhaled Placebo is the first listed.
NCT00721955 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00721955 about?
NCT00721955 is a clinical study titled "Staccato Loxapine in Agitated Patients With Bipolar Disorder". Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.
What is the current status of trial NCT00721955?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 314 participants. The study started on 2008-07. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00721955?
The interventions under investigation include: Inhaled Placebo (DRUG), Inhaled loxapine 5 mg (DRUG), Inhaled loxapine 10 mg (DRUG).
Who is sponsoring clinical trial NCT00721955?
This trial is sponsored by Alexza Pharmaceuticals, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00721955's enrollment target sits among peer trials
314 1096th of 2000 higher than 900 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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