Who is sponsoring NCT00422812?

NCT00422812 is sponsored by Alexza Pharmaceuticals, Inc..

What condition does NCT00422812 study?

NCT00422812 studies Migraine Headache, Aura.

What drugs are being tested in NCT00422812?

Interventions: Inhaled Placebo, Inhaled PCZ 5 mg, Inhaled PCZ 7.5 mg, Inhaled PCZ 10 mg.

What is the status of NCT00422812?

NCT00422812 is currently COMPLETED.

Last reviewed 2017-06-16 · How we verify

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

NCT00422812 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Alexza Pharmaceuticals, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	400
Start date	2006-04
Completion	2007-01

Conditions

Migraine Headache
Aura

Interventions

Inhaled Placebo
Inhaled PCZ 5 mg
Inhaled PCZ 7.5 mg
Inhaled PCZ 10 mg

Primary outcomes

Headache Pain Relief at 2 hr — 2 hr post-dose
Headache pain relief at 2 hr post-dose by IHS Definition (none=0 or mild=1),

Countries

United States