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Sponsored by: |
Alexza Pharmaceuticals, Inc. |
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Information provided by: | Alexza Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00369577 |
The purpose of this study is to assess efficacy and safety of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients. The study will be conducted in 120 agitated schizophrenic patients - either newly admitted to a hospital setting or a research unit for acute agitation or already in hospital for chronic underlying conditions. Patients meeting entry criteria will be randomized to one of two doses of Staccato Loxapine or to Staccato Placebo. Following administration of study drug, assessment of agitation state will be conducted at serial time points using standard agitation scales over a 24 hour period.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: Loxapine thermal aerosol |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Efficacy and Safety Study of StaccatoTM Loxapine for Inhalation in Schizophrenic Patients With Agitation. |
Estimated Enrollment: | 120 |
Study Start Date: | August 2006 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | AMDC-004-201 |
Study First Received: | August 25, 2006 |
Last Updated: | January 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00369577 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Agitation Schizophrenia |
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Central Nervous System Depressants Psychomotor Agitation Antipsychotic Agents Schizophrenia |
Dopamine Mental Disorders Loxapine Psychotic Disorders Dopamine Agents Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents |
Pharmacologic Actions Schizophrenia Mental Disorders Therapeutic Uses Loxapine Dopamine Agents Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features |