A Multi-center, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of StaccatoTM Prochlorperazine for Inhalation in Patients With Migraine Headache

Alexza Pharmaceuticals, Inc.1 site in 1 country75 target enrollmentMarch 2005

ConditionsMigraine Headache, With or Without Aura

InterventionsStaccato Placebo Staccato Prochlorperazine 5 mg Staccato Prochlorperazine 10 mg

DrugsStaccato Placebo Staccato Prochlorperazine 5 mg Staccato Prochlorperazine 10 mg

Overview

Phase: Phase 2
Intervention: Staccato Placebo
Conditions: Migraine Headache, With or Without Aura
Sponsor: Alexza Pharmaceuticals, Inc.
Enrollment: 75
Locations: 1
Primary Endpoint: Headache Pain Relief at 2 hr Post-dose by 2-point Definition
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Development of Staccato Prochlorperazine for the treatment of migraine headache.

Registry

clinicaltrials.gov

Start Date

March 2005

End Date

October 2005

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alexza Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who have migraine headache with or without aura (diagnosis according to International Headache Society guidelines) for at least 6 months, who have been pain free for at least 48 hours since the end of their last migraine attack, who have a pain rating of Moderate or Severe prior to dosing.

Exclusion Criteria

•Subjects who have taken any other migraine or pain medication within 48 hours of randomization, with a history of allergy or intolerance to phenothiazines and related drugs, or are considered by the investigator, for any reason, to be an unsuitable candidate for receiving prochlorperazine, or unable to use the inhalation device, must be excluded.

Arms & Interventions

Inhaled Placebo

Inhaled Staccato Placebo

Intervention: Staccato Placebo

Inhaled PCZ 5 mg

Inhaled Staccato Prochlorperazine 5 mg

Intervention: Staccato Prochlorperazine 5 mg

Inhaled PCZ 10 mg

Inhaled Staccato Prochlorperazine 10 mg

Intervention: Staccato Prochlorperazine 10 mg

Outcomes

Primary Outcomes

Headache Pain Relief at 2 hr Post-dose by 2-point Definition

Time Frame: 2 hours after treatment

patient headache pain relief defined as a 2 point reduction as measured on the scale: 0=NO headache pain, 1 = MILD headache pain, 2 = MODERATE headache pain, 3 = SEVERE headache pain