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Staccato® Loxapine Treatment of Agitation in Bipolar Disorder Patients (AMDC-004-302)

This study has been completed.
Information provided by:
Alexza Pharmaceuticals, Inc. Identifier:
First received: July 23, 2008
Last updated: October 22, 2008
Last verified: October 2008
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

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 ]

Secondary Outcome Measures:
  • Clinical Global Impression-Improvement (CGI-I) score following Dose #1 of Staccato Loxapine, compared with placebo [ Time Frame: 2 hr ]
  • Treatment emergent adverse events, compared with placebo [ Time Frame: 24 hr ]

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
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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00721955

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

Responsible Party: Robert S. Fishman, MD, FCCP; Vice President, Clinical Development, Alexza Pharmaceuticals, Inc. Identifier: NCT00721955     History of Changes
Other Study ID Numbers: AMDC-004-302
Study First Received: July 23, 2008
Last Updated: October 22, 2008

Keywords provided by Alexza Pharmaceuticals, Inc.:
Bipolar 1 disorder,

Additional relevant MeSH terms:
Psychomotor Agitation
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
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 processed this record on May 25, 2017