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Staccato® Loxapine Treatment of Schizophrenic Patients With Agitation

This study has been completed.
Sponsor:
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00628589
First received: February 25, 2008
Last updated: June 10, 2008
Last verified: June 2008
  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:


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
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 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):
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
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Psychomotor Disorders
Signs and Symptoms
Loxapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014