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Staccato Loxapine in Migraine (Out Patient)

NCT00825500 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2017-04-24

Study results available
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Summary

Assess the safety and efficacy of Staccato Loxapine in patients with moderate to severe migraine headache with or without aura in an outpatient setting.

Conditions

  • Migraine Headache

Interventions

DRUG

Inhaled Placebo

Inhaled Staccato placebo (0 mg)

DRUG

Inhaled Loxapine 1.25 mg

Inhaled Staccato Loxapine 1.25 mg, single dose

DRUG

Inhaled Loxapine 2.5 mg

Inhaled Staccato Loxapine 1.25 mg, single dose

Sponsors & Collaborators

  • Alexza Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Roger K. Cady, MD · Clinvest

  • Peter J. Bellafiore, MD · CNS Research, Inc.

  • Arthur Elkind, MD · Elkind Headache Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-08-31
Completion
2009-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00825500 on ClinicalTrials.gov