Staccato Loxapine in Agitated Patients With Bipolar Disorder

NCT00721955 | Completed Phase 3 Results FDA Drug

• 1 other identifier: AMDC-004-302
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Bipolar I Disorder

Keywords

Bipolar 1 disorder,; agitation,; acute,; treatment

Outcome Measures

Primary Outcomes (1)

• Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo

  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.

  Baseline and 2 hours

Secondary Outcomes (2)

• Clinical Global Impression-Improvement (CGI-I) Score Following Dose #1 of Staccato Loxapine, Compared With Placebo

  Baseline and 2 hours

• CGI-I Responders

  Baseline and 2 hours

Study Arms (3)

Inhaled Placebo

PLACEBO COMPARATOR

Inhaled Staccato Placebo, may repeat after 2 hours x 2

Drug: Inhaled Placebo

Inhaled Loxapine 5 mg

EXPERIMENTAL

Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2

Drug: Inhaled loxapine 5 mg

Inhaled Loxapine 10 mg

EXPERIMENTAL

Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2

Drug: Inhaled loxapine 10 mg

Interventions

Inhaled Placebo DRUG

Inhaled loxapine Placebo, may repeat after 2 hours x 2

Also known as: Staccato Placebo

Inhaled Placebo

Inhaled loxapine 5 mg DRUG

Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2

Also known as: ADASUVE 5 mg

Inhaled Loxapine 5 mg

Inhaled loxapine 10 mg DRUG

Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2

Also known as: ADASUVE 10 mg

Inhaled Loxapine 10 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexza Pharmaceuticals, Inc.: lead

Study Sites (6)

Synergy Escondido

Escondido, California, 92025, United States

Location

Collaborative NeuroScience Network, Inc.

Garden Grove, California, 92845, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

FutureSearch Trials

Austin, Texas, 78756, United States

Location

Claghorn-Lesem Research Clinic

Houston, Texas, 77008, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98004, United States

Location

Related Publications (2)

• 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.

  PMID: 22329470 BACKGROUND

• 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.

  PMID: 29163985 DERIVED

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Loxapine

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzoxazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Because of the need to provide informed consent, the types of patients enrolled in the study may not have been representative of the most severely agitated patients who present for emergency care.

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Alexza Pharmaceuticals, Inc

:jcassella@alexza.com

650.944.7777

Study Officials

• Robert S Fishman, MD

  Alexza Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: July 25, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: July 26, 2017
• Results First Posted: June 29, 2017

Record last verified: 2008-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)