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Staccato Loxapine in Agitated Patients With Bipolar Disorder

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.
ClinicalTrials.gov Identifier: NCT00721955
Recruitment Status : Completed
First Posted : July 25, 2008
Results First Posted : June 29, 2017
Last Update Posted : July 26, 2017
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Drug: Inhaled Placebo Drug: Inhaled loxapine 5 mg Drug: Inhaled loxapine 10 mg Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
Placebo Comparator: Inhaled Placebo
Inhaled Staccato Placebo, may repeat after 2 hours x 2
Drug: Inhaled Placebo
Inhaled loxapine Placebo, may repeat after 2 hours x 2
Other Name: Staccato Placebo

Experimental: Inhaled Loxapine 5 mg
Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
Drug: Inhaled loxapine 5 mg
Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2
Other Name: ADASUVE 5 mg

Experimental: Inhaled Loxapine 10 mg
Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2
Drug: Inhaled loxapine 10 mg
Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2
Other Name: ADASUVE 10 mg

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721955

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United States, California
Synergy Escondido
Escondido, California, United States, 92025
Collaborative NeuroScience Network, Inc.
Garden Grove, California, United States, 92845
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
United States, Texas
FutureSearch Trials
Austin, Texas, United States, 78756
Claghorn-Lesem Research Clinic
Houston, Texas, United States, 77008
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
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Study Director: Robert S Fishman, MD Alexza Pharmaceuticals, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00721955    
Other Study ID Numbers: AMDC-004-302
First Posted: July 25, 2008    Key Record Dates
Results First Posted: June 29, 2017
Last Update Posted: July 26, 2017
Last Verified: October 2008
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexza Pharmaceuticals, Inc.:
Bipolar 1 disorder,
Additional relevant MeSH terms:
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Pathologic Processes
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action