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Staccato Prochlorperazine in Migraine (Out Patient)

NCT00422812 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2018-01-25

Study results available
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Summary

Staccato Prochlorperazine is being developed to treat patients suffering from acute migraine headaches. In October 2005, we completed a 75 patient, multi-center, double-blind placebo-controlled Phase 2A clinical trial in patients suffering from moderate to severe acute migraine headaches. This Phase 2B clinical trial of Staccato Prochlorperazine has been initiated to assess the efficacy and safety in outpatients with migraine headache with or without aura.

Conditions

  • Migraine Headache
  • Aura

Interventions

DRUG

Inhaled Placebo

Inhaled Staccato Placebo

DRUG

Inhaled PCZ 5 mg

Inhaled Staccato Prochlorperazine 5 mg

DRUG

Inhaled PCZ 7.5 mg

Inhaled Staccato Prochlorperazine 7.5 mg

DRUG

Inhaled PCZ 10 mg

Inhaled Staccato Prochlorperazine 10 mg

Sponsors & Collaborators

  • Alexza Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel A Spyker, PhD, MD · Alexza Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2007-01-31
Completion
2007-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT00422812 on ClinicalTrials.gov