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Staccato® Loxapine Treatment of Agitation in Bipolar Disorder Patients (AMDC-004-302)

This study has been completed.
Sponsor:
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00721955
First received: July 23, 2008
Last updated: October 22, 2008
Last verified: October 2008
History of Changes

July 23, 2008
October 22, 2008
July 2008
October 2008   (final data collection date for primary outcome measure)
Change in PANSS Excited component (PEC) score from baseline following Dose #1 of Staccato Loxapine, compared with placebo [ Time Frame: 2 hr ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00721955 on ClinicalTrials.gov Archive Site
  • Clinical Global Impression-Improvement (CGI-I) score following Dose #1 of Staccato Loxapine, compared with placebo [ Time Frame: 2 hr ] [ Designated as safety issue: Yes ]
  • Treatment emergent adverse events, compared with placebo [ Time Frame: 24 hr ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Staccato® Loxapine Treatment of Agitation in Bipolar Disorder Patients
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

Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bipolar I Disorder
  • Drug: loxapine
    Staccato loxapine 5 mg
  • Drug: loxapine
    Staccato loxapine 10 mg
  • Drug: placebo
    Staccato Placebo
  • Experimental: 1
    Intervention: Drug: loxapine
  • Experimental: 2
    Intervention: Drug: loxapine
  • Placebo Comparator: 3
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female adult patients with bipolar 1 disorder and acute agitation

Exclusion Criteria:

  • Agitation caused primarily by acute intoxication
  • History of drug or alcohol dependence
  • Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00721955
AMDC-004-302
No
Robert S. Fishman, MD, FCCP; Vice President, Clinical Development, Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals, Inc.
Not Provided
Study Director: Robert S Fishman, MD Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals, Inc.
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP