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