Staccato® Loxapine Treatment of Agitation in Bipolar Disorder Patients - Full Text View

Sponsored by:	Alexza Pharmaceuticals, Inc.
Information provided by:	Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00721955

Purpose

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

Condition	Intervention	Phase
Bipolar I Disorder	Drug: loxapine Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Loxapine succinate Loxapine hydrochloride Loxapine

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: Yes ]
Treatment emergent adverse events, compared with placebo [ Time Frame: 24 hr ] [ Designated as safety issue: Yes ]

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721955

Locations

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

Study Director:

Robert S Fishman, MD

Alexza Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Alexza Pharmaceuticals, Inc. ( Robert S. Fishman, MD, FCCP; Vice President, Clinical Development )
Study ID Numbers:	AMDC-004-302
Study First Received:	July 23, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00721955 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alexza Pharmaceuticals, Inc.:

Bipolar 1 disorder,
agitation,
acute,
treatment

Study placed in the following topic categories:

Neurotransmitter Agents
Dopamine
Tranquilizing Agents
Bipolar Disorder
Psychotropic Drugs

Loxapine
Central Nervous System Depressants
Dopamine Agents
Psychomotor Agitation
Antipsychotic Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Loxapine
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 09, 2009