Staccato Prochlorperazine in Migraine (in Clinic)

Migraine Headache, With or Without Aura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610428
• Other study ID #: AMDC-001-201
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2008
• Last updated: June 17, 2017
• Start date: March 2005
• Est. completion date: October 2005

Study information

• Verified date: January 2008
• Source: Alexza Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Development of Staccato Prochlorperazine for the treatment of migraine headache.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache, With or Without Aura

Intervention

Drug:
• Staccato Placebo
Inhaled Staccato Placebo
• Staccato Prochlorperazine 5 mg
Inhaled Prochlorperazine 5 mg
• Staccato Prochlorperazine 10 mg
Inhaled Prochlorperazine10 mg

Locations

Country	Name	City	State
United States	Arthur H. Elkind, MD	Mount Vernon	New York

Sponsors (1)

Lead Sponsor	Collaborator
Alexza Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Avram MJ, Spyker DA, Henthorn TK, Cassella JV. The pharmacokinetics and bioavailability of prochlorperazine delivered as a thermally generated aerosol in a single breath to volunteers. Clin Pharmacol Ther. 2009 Jan;85(1):71-7. doi: 10.1038/clpt.2008.184. Epub 2008 Oct 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Pain Relief at 2 hr Post-dose by 2-point Definition	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	2 hours after treatment
Secondary	Survival Analysis for Time to Pain Relief	Survival Analysis for Time to the First Success Based on Pain Relief by 2-Point Definition	from treatment (time = 0) to 2 hours post treatment