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Staccato Loxapine in Migraine (Out Patient)

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

Intervention: High dose (Drug); Low dose (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Alexza Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Roger K. Cady, MD, Principal Investigator, Affiliation: Clinvest, A Division of Banyan Group Inc.
Peter J. Bellafiore, MD, Principal Investigator, Affiliation: CNS Research, Inc.
Arthur Elkind, MD, Principal Investigator, Affiliation: Elkind Headache Center


Assess the safety and efficacy of Staccato Loxapine in patients with moderate to severe migraine headache with or without aura in an outpatient setting.

Clinical Details

Official title: A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Efficacy and Safety Study of StaccatoŽ Loxapine for Inhalation in Outpatients With Migraine Headache

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

Primary outcome: Pain-Relief

Secondary outcome: Pain free, Nausea, Photophobia, Phonophobia


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


Inclusion Criteria:

- History of migraine headache with or without aura, pain rating of Moderate or Severe

(on a None-Mild- Moderate-Severe Scale) prior to dosing.

Locations and Contacts

Roger K. Cady, Springfield, Missouri 65807, United States

Elkind Headache Center, Mount Vernon, New York 10550, United States

CNS Research, Inc., East Providence, Rhode Island 02916, United States

Additional Information

Starting date: January 2009
Last updated: August 28, 2009

Page last updated: August 23, 2015

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