CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 400 enrolled
Drug / intervention
Inhaled Placebo +3 moredrug
Likely dose
Inhaled PCZ 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00422812
NCT00422812Phase 2Completed
CompareCT.gov

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

Alexza Pharmaceuticals, Inc.·interventional·Posted Jan 17, 2007·Updated Jan 25, 2018

In Brief

A Phase 2 clinical trial evaluating Inhaled Placebo, Inhaled PCZ 5 mg, and 2 other interventions for Migraine Headache and Aura. Completed, enrolled 400 participants across 25 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Headache, Aura
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 17, 2007
Enrollment StartApr 1, 2006
Primary CompletionJan 1, 2007
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 19.5 years ago

Interventions

Inhaled Placebodrug

Inhaled Staccato Placebo

Inhaled PCZ 5 mgdrug

Inhaled Staccato Prochlorperazine 5 mg

Inhaled PCZ 7.5 mgdrug

Inhaled Staccato Prochlorperazine 7.5 mg

Inhaled PCZ 10 mgdrug

Inhaled Staccato Prochlorperazine 10 mg