Staccato® Loxapine Treatment of Schizophrenic Patients With Agitation - Full Text View

Purpose

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

Condition	Intervention	Phase
Schizophrenic Patients With Acute Agitation	Drug: loxapine Drug: placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 Schizophrenic Patients With Agitation

Resource links provided by NLM:

Drug Information available for: Loxapine Loxapine succinate Loxapine hydrochloride

U.S. FDA Resources

Further study details as provided by Alexza Pharmaceuticals, Inc.:

Primary Outcome Measures:

Change in PANSS Excited Component (PEC) score from baseline following Dose #1 of Staccato Loxapine, compared with placebo [ Time Frame: 2 hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Global Impression-Improvement (CGI-I) score following Dose #1 of Staccato Loxapine, compared with placebo [ Time Frame: 2 hr ] [ Designated as safety issue: No ]
Treatment emergent adverse events, compared with placebo [ Time Frame: 24 hr ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	February 2008
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: loxapine Staccato Loxapine, 5 mg
Experimental: 2	Drug: loxapine Staccato Loxapine, 10 mg
Placebo Comparator: 3	Drug: placebo Staccato Placebo

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female adult patients with schizophrenia 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628589

Locations

United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308

Sponsors and Collaborators

Alexza Pharmaceuticals, Inc.

Investigators

Study Director:

Robert S Fishman, MD

Alexza Pharmaceuticals, Inc.

More Information

No publications provided by Alexza Pharmaceuticals, Inc.

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

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;198:51-8.

Responsible Party:	Robert S. Fishman, MD, FCCP; Vice President, Medical Affairs, Alexza Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT00628589 History of Changes
Other Study ID Numbers:	AMDC-004-301, 7 December 2007
Study First Received:	February 25, 2008
Last Updated:	June 10, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alexza Pharmaceuticals, Inc.:

schizophrenia, agitation, acute, treatment

Additional relevant MeSH terms:

Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Loxapine
Antipsychotic Agents
Tranquilizing Agents

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013