NCT00422812

Staccato Prochlorperazine in Migraine (Out Patient)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2007-01-17
• Last updated: 2018-01-25
• Results posted: 2018-01-25

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study