deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT00721955

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.

Updated 9 times since 2017 Last updated: Jun 28, 2017 Started: Jul 31, 2008 Primary completion: Oct 31, 2008 Completion: Oct 31, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshotCompleted~Aug 2017 – ~Jun 2018 · 10 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Feb 2026 · 17 months · monthly snapshotCompleted~Feb 2026 – present · 5 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Feb 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Feb 2026 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE3

Show 4 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  2. Aug 2017 — Jun 2018 [monthly]

    Completed PHASE3

  3. Feb 2017 — Aug 2017 [monthly]

    Completed PHASE3

  4. 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

Sponsor contact:
  • Alexza Pharmaceuticals, Inc.
Data source: Nova Pneuma Inc.

For direct contact, visit the study record on ClinicalTrials.gov .