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Staccato Prochlorperazine in Patients With Migraine Headache

Information source: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine Headache, With or Without Aura

Intervention: Staccato Prochlorperazine (Drug); Staccato Prochlorperazine (Drug); Staccato Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Alexza Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Sheena Auroa, MD, Principal Investigator
Roger K Cady, MD, Principal Investigator
Arthur Elkind, MD, Principal Investigator
Fred Freitag, DO, Principal Investigator
Lisa Mannix, MD, Principal Investigator
Niana T Mathew, MD, Principal Investigator
Egilius LH Spierings, MD, Principal Investigator
Stewart Tepper, MD, Principal Investigator

Summary

Development of Staccato Prochlorperazine for the treatment of migraine headache.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: patient headache pain as measured on the scale: 0=NO headache pain, to 3=severe headache pain Measure: 1 = MILD headache pain Measure: 2 = MODERATE headache pain Measure: 3 = SEVERE headac

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Arthur H. Elkind, MD, Mount Vernon, New York 10550, United States
Additional Information

Starting date: March 2005
Last updated: January 28, 2008

Page last updated: August 23, 2015

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