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Staccato Loxapine in Agitated Patients With Bipolar Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00721955
First Posted: July 25, 2008
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.
July 23, 2008
July 25, 2008
March 13, 2017
June 29, 2017
July 26, 2017
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: Baseline and 2 hours ]
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.
Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo [ Time Frame: 2 hr ]
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: Baseline and 2 hours ]
    Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.
  • CGI-I Responders [ Time Frame: Baseline and 2 hours ]
    Frequency of response based on the CGI-I (defined as achieving a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)
  • Clinical Global Impression-Improvement (CGI-I) Score Following Dose #1 of Staccato Loxapine, Compared With Placebo [ Time Frame: 2 hr ]
  • Treatment emergent adverse events, compared with placebo [ Time Frame: 24 hr ]
Not Provided
Not Provided
 
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
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bipolar I Disorder
  • Drug: Inhaled Placebo
    Inhaled loxapine Placebo, may repeat after 2 hours x 2
    Other Name: Staccato Placebo
  • Drug: Inhaled loxapine 5 mg
    Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2
    Other Name: ADASUVE 5 mg
  • Drug: Inhaled loxapine 10 mg
    Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2
    Other Name: ADASUVE 10 mg
  • Placebo Comparator: Inhaled Placebo
    Inhaled Staccato Placebo, may repeat after 2 hours x 2
    Intervention: Drug: Inhaled Placebo
  • Experimental: Inhaled Loxapine 5 mg
    Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
    Intervention: Drug: Inhaled loxapine 5 mg
  • Experimental: Inhaled Loxapine 10 mg
    Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
    Intervention: Drug: Inhaled loxapine 10 mg
Kwentus J, Riesenberg RA, Marandi M, Manning RA, Allen MH, Fishman RS, Spyker DA, Kehne JH, Cassella JV. Rapid acute treatment of agitation in patients with bipolar I disorder: a multicenter, randomized, placebo-controlled clinical trial with inhaled loxapine. Bipolar Disord. 2012 Feb;14(1):31-40. doi: 10.1111/j.1399-5618.2011.00975.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
314
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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00721955
AMDC-004-302
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
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