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

This study has been completed.
Sponsor:
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00721955
First received: July 23, 2008
Last updated: October 22, 2008
Last verified: October 2008
History of Changes
  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 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 Patients With Bipolar I Disorder and Acute Agitation

Resource links provided by NLM:

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

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

Additional relevant MeSH terms:
Bipolar Disorder
Psychomotor Agitation
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
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