Staccato Loxapine in Agitated Patients With Schizophrenia

NCT00628589 | Completed Phase 3 Results FDA Drug

• 1 other identifier: AMDC-004-301
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients

Conditions

Patients With Schizophrenia and Acute Agitation

Keywords

schizophrenia, agitation, inhaled loxapine, ADASUVE

Outcome Measures

Primary Outcomes (1)

• Change in PANSS-EC From Baseline

  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

  Baseline and 2 hours

• CGI-I Responders

  Baseline and 2 hours

Study Arms (3)

Inhaled Loxapine 5 mg

EXPERIMENTAL

Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours

Drug: Inhaled loxapine 5 mg

Inhaled Loxapine 10 mg

EXPERIMENTAL

Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours

Drug: Inhaled loxapine 10 mg

Inhaled placebo

PLACEBO COMPARATOR

Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours

Drug: Inhaled placebo

Interventions

Inhaled loxapine 5 mg DRUG

Inhaled loxapine 5 mg

Also known as: ADASUVE

Inhaled Loxapine 5 mg

Inhaled loxapine 10 mg DRUG

Inhaled loxapine 10 mg

Also known as: ADASUVE

Inhaled Loxapine 10 mg

Inhaled placebo DRUG

Inhaled placebo

Inhaled placebo

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 schizophrenia 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 (1)

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Related Publications (2)

• Lesem MD, Tran-Johnson TK, Riesenberg RA, Feifel D, Allen MH, Fishman R, Spyker DA, Kehne JH, Cassella JV. Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine. Br J Psychiatry. 2011 Jan;198(1):51-8. doi: 10.1192/bjp.bp.110.081513.

  PMID: 21200077 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

Schizophrenia; Psychomotor Agitation

Interventions

Loxapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; 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: Executive VP, Research & Development, Regulatory & Quality
• Organization: Alexza Pharmaceuticals, Inc

ClinicalTrialsInfo@alexza.com

650.944.7071

Study Officials

• Robert S Fishman, MD

  Alexza Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: February 25, 2008
• First Posted: March 5, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: July 26, 2017
• Results First Posted: June 29, 2017

Record last verified: 2008-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)