Staccato Loxapine Multidose PK

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2007-12-31

Brief Summary

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The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of multiple inhaled doses of Staccato Loxapine.

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Detailed Description

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The purpose of the present Phase 1 study in schizophrenic patients is to assess the safety and pharmacokinetics of multiple doses of Staccato Loxapine given within a 24 hour time period. The study will be conducted in schizophrenic patients who are on chronic, stable antipsychotic medication. Patients meeting entry criteria will be randomized to one of three dose sequences of Staccato Loxapine or to Staccato Placebo. Following administration of medications, safety, tolerability and pharmacokinetic assessments will be conducted at serial time points.

Conditions

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Volunteers on Chronic, Stable Antipsychotic Regimens

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A - 10 mg loxapine q 4 h x 3 (30 mg total)

Group Type EXPERIMENTAL

A - 10 mg loxapine q 4 h x 3 (30 mg total)

Intervention Type DRUG

loxapine aerosol inhalation high dose regimen (30 mg total)

B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)

Group Type EXPERIMENTAL

B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)

Intervention Type DRUG

loxapine aerosol inhalation middle dose regimen (20 mg total)

C - 5 mg loxapine q 4 h x 3 (15 mg total)

Group Type EXPERIMENTAL

C - 5 mg loxapine q 4 h x 3 (15 mg total)

Intervention Type DRUG

loxapine aerosol inhalation low dose regimen (15 mg total)

D - inhaled placebo q 4 h x 3

Group Type PLACEBO_COMPARATOR

D - inhaled placebo q 4 h x 3

Intervention Type DRUG

placebo aerosol inhalation (0 mg total)

Interventions

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A - 10 mg loxapine q 4 h x 3 (30 mg total)

loxapine aerosol inhalation high dose regimen (30 mg total)

Intervention Type DRUG

B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)

loxapine aerosol inhalation middle dose regimen (20 mg total)

Intervention Type DRUG

C - 5 mg loxapine q 4 h x 3 (15 mg total)

loxapine aerosol inhalation low dose regimen (15 mg total)

Intervention Type DRUG

D - inhaled placebo q 4 h x 3

placebo aerosol inhalation (0 mg total)

Intervention Type DRUG

Other Intervention Names

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Staccato Loxapine 10 mg Staccato Loxapine 5 and 10 mg Staccato Loxapine 5 mg Staccato Placebo

Eligibility Criteria

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Inclusion Criteria

1. Male and female subjects between the ages of 18 to 65 years, inclusive.
2. Subjects who are on stable, oral, chronic (\>2 mos) antipsychotic medication regimen and who are able to tolerate the rapid oral dose taper and substitution regimen.

Exclusion Criteria

1. Subjects who are currently treated with injectable depot neuroleptics within one dose interval must be excluded.
2. Subjects who have received loxapine or amoxapine within the last 30 days must be excluded.
3. Subjects with a history of allergy or intolerance to dibenzoxazepines (loxapine and amoxapine) must be excluded.
4. Subjects with a history of movement disorders including Parkinson's disease or a history of neuroleptic malignant syndrome must be excluded.
5. Subjects who have a history within the past year of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No