Staccato Loxapine in Agitated Patients With Schizophrenia

Alexza Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Patients With Schizophrenia and Acute Agitation

Treatments: Drug: Inhaled placebo; Drug: Inhaled loxapine 5 mg; Drug: Inhaled loxapine 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00628589

AMDC-004-301

Details and patient eligibility

About

Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients

Full 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.

Enrollment: 344 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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344 participants in 3 patient groups, including a placebo group

Inhaled Loxapine 5 mg

Experimental group

Description:

Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours

Treatment:

Drug: Inhaled loxapine 5 mg

Inhaled Loxapine 10 mg

Experimental group

Description:

Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours

Treatment:

Drug: Inhaled loxapine 10 mg

Inhaled placebo

Placebo Comparator group

Description:

Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours

Treatment:

Drug: Inhaled placebo