Staccato Loxapine in Agitated Patients With Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00721955

Recruitment Status : Completed

First Posted : July 25, 2008

Results First Posted : June 29, 2017

Last Update Posted : July 26, 2017

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Alexza Pharmaceuticals, Inc.

Study Description

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.

Study Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bipolar disorder

Drug Information available for: Loxapine Loxapine succinate Loxapine hydrochloride

Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 :

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)

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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

Locations

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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.

Investigators

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Study Director:	Robert S Fishman, MD	Alexza Pharmaceuticals, Inc.

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zeller S, Zun L, Cassella JV, Spyker DA, Yeung PP. Response to inhaled loxapine in patients with schizophrenia or bipolar I disorder: PANSS-EC responder analyses. BJPsych Open. 2017 Nov 10;3(6):285-290. doi: 10.1192/bjpo.bp.117.005363. eCollection 2017 Nov.

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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, agitation, acute, treatment

Additional relevant MeSH terms:

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Disease Pathologic Processes Loxapine 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

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